Coronary Artery Disease, Hypercholesterolemia, Hypertension
Conditions
Brief summary
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。
Interventions
OTHERNo intervention
Because this is a non-interventional study, there is no intervention here.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥18 years; * Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia. * Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy. * Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.
Exclusion criteria
* Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment * Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall | 12 weeks | Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up. |
| Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | 12 weeks | Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Baseline to Week 12 | Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline data was reported. |
| Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Baseline to Week 12 | Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported. |
| Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Day 1 to Week 12 | Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12 |
| Study Drug Exposure for Overall - Daily Dose | Day 1 to Week 12 | Daily dose was calculated by total dose divided by the total days of receiving atorvastatin. |
| Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Day 1 to Week 12 | Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Day 1 to Week 12 | Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 ) | All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 ) | All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Number of Participants With Adverse Events of Special Interest (AESI) for Overall | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16) | AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death. |
| Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Change From Baseline for Lipid Parameters at Week 12 for Overall | Baseline to Week 12 | Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline data was reported. |
| Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Change From Baseline for Clinical Laboratory Overall- ALT and AST | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported. |
| Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported. |
| Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported. |
| Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16) | The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5%\ 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%\ 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Precentage of Participants With Discontinuation From the Study for Overall | 12 weeks of follow-up | Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall. |
| Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | 12 weeks of follow-up | Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. |
| Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16) | The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range. |
| Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Baseline to Week 12 | Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin <=10 mg Participants received Atorvastatin \<=10 mg daily according to doctor's prescription. | 291 |
| Atorvastatin 20 mg Participants received Atorvastatin 20 mg daily according to doctor's prescription. | 3,080 |
| Atorvastatin 30 mg Participants received Atorvastatin 30 mg daily according to doctor's prescription. | 21 |
| Atorvastatin 40 mg Participants received Atorvastatin 40 mg daily according to doctor's prescription. | 101 |
| Atorvastatin Unknown Dosage Participants didn't complete dosing information including dosing page recording 'NOT DONE', or missing Week 12 dosing event, or records with missing stop date of dosing. | 1,055 |
| Total | 4,548 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 0 | 9 |
| Overall Study | Death | 0 | 1 | 0 | 0 | 4 |
| Overall Study | Lost to Follow-up | 0 | 4 | 0 | 1 | 765 |
| Overall Study | Not meeting eligibility criteria | 0 | 7 | 0 | 0 | 25 |
| Overall Study | Not willing to participate in study | 2 | 21 | 0 | 1 | 169 |
| Overall Study | Reason not defined | 0 | 2 | 0 | 1 | 62 |
| Overall Study | Untreated | 0 | 0 | 0 | 0 | 567 |
Baseline characteristics
| Characteristic | Atorvastatin <=10 mg | Atorvastatin 20 mg | Atorvastatin 30 mg | Atorvastatin 40 mg | Atorvastatin Unknown Dosage | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 64.2 Years STANDARD_DEVIATION 12 | 61.3 Years STANDARD_DEVIATION 11.6 | 59.5 Years STANDARD_DEVIATION 8.4 | 63.2 Years STANDARD_DEVIATION 11.3 | 62.2 Years STANDARD_DEVIATION 12.3 | 61.7 Years STANDARD_DEVIATION 11.8 |
| Height | 163.3 cm STANDARD_DEVIATION 7.8 | 164.6 cm STANDARD_DEVIATION 7.8 | 166.0 cm STANDARD_DEVIATION 6.9 | 163.8 cm STANDARD_DEVIATION 8.4 | 164.1 cm STANDARD_DEVIATION 7.7 | 164.4 cm STANDARD_DEVIATION 7.8 |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 144 Participants | 1390 Participants | 11 Participants | 39 Participants | 483 Participants | 2067 Participants |
| Sex: Female, Male Male | 147 Participants | 1690 Participants | 10 Participants | 62 Participants | 572 Participants | 2481 Participants |
| Weight | 64.9 kg STANDARD_DEVIATION 11 | 67.9 kg STANDARD_DEVIATION 11.8 | 68.6 kg STANDARD_DEVIATION 8.2 | 67.5 kg STANDARD_DEVIATION 11.4 | 66.0 kg STANDARD_DEVIATION 12.2 | 67.3 kg STANDARD_DEVIATION 11.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 291 | 2 / 3,080 | 0 / 21 | 0 / 101 | 5 / 1,055 |
| other Total, other adverse events | 0 / 291 | 0 / 3,080 | 0 / 21 | 0 / 101 | 0 / 1,055 |
| serious Total, serious adverse events | 5 / 291 | 68 / 3,080 | 0 / 21 | 3 / 101 | 9 / 1,055 |
Outcome results
Primary
Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: 12 weeks
Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin <=10 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | High risk | 0.77 Ratio |
| Atorvastatin <=10 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Low risk | 1.00 Ratio |
| Atorvastatin <=10 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Very High risk | 0.53 Ratio |
| Atorvastatin <=10 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Moderate risk | 1.00 Ratio |
| Atorvastatin 20 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Moderate risk | 0.89 Ratio |
| Atorvastatin 20 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Low risk | 0.93 Ratio |
| Atorvastatin 20 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | High risk | 0.68 Ratio |
| Atorvastatin 20 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Very High risk | 0.48 Ratio |
| Atorvastatin 30 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | High risk | 0.83 Ratio |
| Atorvastatin 40 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Low risk | 1.00 Ratio |
| Atorvastatin 40 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Very High risk | 0.45 Ratio |
| Atorvastatin 40 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | Moderate risk | 0.78 Ratio |
| Atorvastatin 40 mg | Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level | High risk | 0.56 Ratio |
Primary
Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall
Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.
Time frame: 12 weeks
Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin <=10 mg | Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall | 0.79 Ratio |
| Atorvastatin 20 mg | Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall | 0.67 Ratio |
| Atorvastatin 30 mg | Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall | 0.83 Ratio |
| Atorvastatin 40 mg | Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall | 0.57 Ratio |
Secondary
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (Low risk)- unplanned visit | -2.80 IU/L | Standard Deviation 7.463 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (moderate risk)- unplanned visit | 0.00 IU/L | Standard Deviation 17.146 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT(very high risk)- Week 12 | -17.98 IU/L | Standard Deviation 56.864 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (moderate risk)-unplanned visit | 2.80 IU/L | Standard Deviation 13.828 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (very high risk)-Week 12 | -14.62 IU/L | Standard Deviation 38.588 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT(very high risk)- unplanned visit | -1.75 IU/L | Standard Deviation 8.382 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (high risk)- Week 12 | 5.27 IU/L | Standard Deviation 14.774 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (very high risk)-unplanned visit | -1.75 IU/L | Standard Deviation 3.862 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (low risk)-Week 12 | -0.76 IU/L | Standard Deviation 9.684 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (Low risk)- Week 12 | -0.28 IU/L | Standard Deviation 14.557 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (high risk)-unplanned visit | -0.75 IU/L | Standard Deviation 5.299 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (low risk)- unplanned visit | -1.00 IU/L | Standard Deviation 2.915 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (moderate risk)- Week 12 | -3.68 IU/L | Standard Deviation 15.438 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (high risk)- unplanned visit | 0.99 IU/L | Standard Deviation 12.118 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (moderate risk)-Week 12 | -5.36 IU/L | Standard Deviation 16.276 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (high risk)-Week 12 | 1.89 IU/L | Standard Deviation 13.031 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (moderate risk)-Week 12 | -1.49 IU/L | Standard Deviation 20.569 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (moderate risk)-unplanned visit | -1.66 IU/L | Standard Deviation 5.743 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (very high risk)-unplanned visit | -30.13 IU/L | Standard Deviation 106.059 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (Low risk)- unplanned visit | 2.21 IU/L | Standard Deviation 15.514 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (moderate risk)- Week 12 | 0.83 IU/L | Standard Deviation 19.97 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (moderate risk)- unplanned visit | -2.40 IU/L | Standard Deviation 16.196 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (high risk)- Week 12 | 3.10 IU/L | Standard Deviation 31.018 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (very high risk)-Week 12 | -17.79 IU/L | Standard Deviation 79.278 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (high risk)- unplanned visit | 4.02 IU/L | Standard Deviation 12.412 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (Low risk)- Week 12 | 1.68 IU/L | Standard Deviation 11.964 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT(very high risk)- Week 12 | -0.66 IU/L | Standard Deviation 25.035 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT(very high risk)- unplanned visit | 1.14 IU/L | Standard Deviation 24.172 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (high risk)-unplanned visit | 0.79 IU/L | Standard Deviation 12.214 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (low risk)-Week 12 | 0.76 IU/L | Standard Deviation 7.857 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (low risk)- unplanned visit | -0.28 IU/L | Standard Deviation 6.874 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (high risk)-Week 12 | -0.21 IU/L | Standard Deviation 21.587 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (high risk)-unplanned visit | 9.00 IU/L | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (high risk)- Week 12 | 1.40 IU/L | Standard Deviation 8.414 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (high risk)- unplanned visit | 5.00 IU/L | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (high risk)-Week 12 | 3.60 IU/L | Standard Deviation 2.966 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (low risk)- unplanned visit | -8.56 IU/L | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (very high risk)-unplanned visit | -164.5 IU/L | Standard Deviation 204.461 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (high risk)-Week 12 | 1.38 IU/L | Standard Deviation 7.432 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (low risk)-Week 12 | 2.50 IU/L | Standard Deviation 7.778 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT(very high risk)- unplanned visit | -17.86 IU/L | Standard Deviation 37.039 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (moderate risk)- Week 12 | 0.77 IU/L | Standard Deviation 6.612 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT(very high risk)- Week 12 | -7.36 IU/L | Standard Deviation 15.789 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (high risk)- Week 12 | 5.79 IU/L | Standard Deviation 11.825 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (very high risk)-Week 12 | -85.34 IU/L | Standard Deviation 111.577 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (Low risk)- unplanned visit | -29.23 IU/L | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | ALT (Low risk)- Week 12 | 4.00 IU/L | Standard Deviation 15.556 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST | AST (moderate risk)-Week 12 | -30.51 IU/L | Standard Deviation 92.532 |
Secondary
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (high risk)- week 12 | -4.70 mg/dL | Standard Deviation 101.889 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (high risk)-week 12 | -27.72 mg/dL | Standard Deviation 44.199 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(high risk)-unplanned | -1.38 mg/dL | Standard Deviation 4.248 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (high risk)- unplanned | -47.56 mg/dL | Standard Deviation 70.51 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (very high risk)-unplanned | 0.04 mg/dL | Standard Deviation 0.053 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (low risk)- Week 12 | -0.01 mg/dL | Standard Deviation 0.237 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (very high risk)- Week 12 | 0.09 mg/dL | Standard Deviation 0.2 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(high risk)-Week 12 | 0.10 mg/dL | Standard Deviation 5.191 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (low risk)- unplanned visit | -0.07 mg/dL | Standard Deviation 0.236 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (low risk)- week 12 | -45.48 mg/dL | Standard Deviation 47.189 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (moderate risk)- Week 12 | 0.02 mg/dL | Standard Deviation 0.191 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (high risk)- unplanned | 0.00 mg/dL | Standard Deviation 0.091 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(moderate risk)-unplanned | -0.83 mg/dL | Standard Deviation 2.386 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (moderate risk)- unplanned visit | -0.21 mg/dL | Standard Deviation 0.237 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (moderate risk)-Week 12 | -0.10 mg/dL | Standard Deviation 0.299 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (high risk)- Week 12 | 0.02 mg/dL | Standard Deviation 0.271 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (low risk)-Week 12 | -0.33 mg/dL | Standard Deviation 0.838 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(moderate risk)-Week 12 | 1.18 mg/dL | Standard Deviation 6.721 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(low risk)-unplanned visit | -0.80 mg/dL | Standard Deviation 0.783 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (high risk)- unplanned visit | 0.03 mg/dL | Standard Deviation 0.294 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (low risk)-unplanned | 0.01 mg/dL | Standard Deviation 0.067 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(low risk)-Week 12 | -1.08 mg/dL | Standard Deviation 3.499 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (very high risk)- Week 12 | 0.06 mg/dL | Standard Deviation 0.209 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (low risk)-unplanned | -0.13 mg/dL | Standard Deviation 0.337 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (very high risk)- unplanned visit | 0.07 mg/dL | Standard Deviation 0.457 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (low risk)-Week 12 | 0.01 mg/dL | Standard Deviation 0.119 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (moderate risk)-Week12 | -0.84 mg/dL | Standard Deviation 2.753 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (low risk)-unplanned | -47.41 mg/dL | Standard Deviation 28.986 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (very high risk)-unplanned | -39.96 mg/dL | Standard Deviation 15.081 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (moderate risk)-unplanned | -0.87 mg/dL | Standard Deviation 0.833 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (very high risk)-unplanned | -0.55 mg/dL | Standard Deviation 1.039 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (high risk)-week 12 | -0.38 mg/dL | Standard Deviation 1.875 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (very high risk)-week 12 | 4.63 mg/dL | Standard Deviation 31.528 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (high risk)-unplanned | -42.78 mg/dL | Standard Deviation 32.877 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (high risk)-unplanned | -0.13 mg/dL | Standard Deviation 0.879 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (moderate risk)-unplanned | -0.07 mg/dL | Standard Deviation 0.089 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (very high risk)-week 12 | -407.9 mg/dL | Standard Deviation 1732.17 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen (Very high risk)- unplanned | -0.89 mg/dL | Standard Deviation 1.766 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (high risk)-Week 12 | 0.02 mg/dL | Standard Deviation 0.175 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (moderate risk)-unplanned | -44.59 mg/dL | Standard Deviation 48.524 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (low risk)- unplanned | 21.42 mg/dL | Standard Deviation 28.999 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen (Very high risk)- Week 12 | 0.21 mg/dL | Standard Deviation 4.794 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (moderate risk)-Week 12 | -27.71 mg/dL | Standard Deviation 41.919 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (moderate risk)- week 12 | 0.00 mg/dL | Standard Deviation 42.967 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (very high risk)- unplanned | -63.50 mg/dL | Standard Deviation 89.174 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (low risk)-Week 12 | -57.68 mg/dL | Standard Deviation 46.926 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (moderate risk)- unplanned | -32.08 mg/dL | Standard Deviation 14.674 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (very high risk)- week 12 | 23.34 mg/dL | Standard Deviation 113.398 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (very high risk)- week 12 | -25.34 mg/dL | Standard Deviation 102.889 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (low risk)-Week 12 | -47.63 mg/dL | Standard Deviation 56.296 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (moderate risk)-Week 12 | -43.23 mg/dL | Standard Deviation 49.231 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (high risk)-week 12 | -56.65 mg/dL | Standard Deviation 551.937 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (moderate risk)-unplanned | -0.01 mg/dL | Standard Deviation 0.101 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (high risk)-Week 12 | 0.01 mg/dL | Standard Deviation 0.201 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (high risk)- unplanned | -0.01 mg/dL | Standard Deviation 0.137 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (moderate risk)-Week12 | -0.16 mg/dL | Standard Deviation 1.335 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (moderate risk)-unplanned | -0.47 mg/dL | Standard Deviation 1.493 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (high risk)-week 12 | -0.07 mg/dL | Standard Deviation 1.447 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (high risk)-unplanned | -0.16 mg/dL | Standard Deviation 1.047 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (very high risk)-week 12 | -0.05 mg/dL | Standard Deviation 1.568 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen (Very high risk)- unplanned | 0.12 mg/dL | Standard Deviation 5.484 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (low risk)- unplanned | -75.82 mg/dL | Standard Deviation 101.162 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (moderate risk)- week 12 | -22.32 mg/dL | Standard Deviation 70.978 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (moderate risk)- unplanned | -53.27 mg/dL | Standard Deviation 61.766 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (high risk)- week 12 | -29.87 mg/dL | Standard Deviation 116.122 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (high risk)- unplanned | -54.85 mg/dL | Standard Deviation 189.895 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (low risk)- Week 12 | -0.03 mg/dL | Standard Deviation 0.27 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (low risk)- unplanned visit | 0.08 mg/dL | Standard Deviation 0.225 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (moderate risk)- Week 12 | 0.01 mg/dL | Standard Deviation 0.305 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (moderate risk)- unplanned visit | 0.01 mg/dL | Standard Deviation 0.219 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (high risk)- Week 12 | 0.03 mg/dL | Standard Deviation 0.333 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (high risk)- unplanned visit | -0.01 mg/dL | Standard Deviation 0.273 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (very high risk)- Week 12 | 0.02 mg/dL | Standard Deviation 0.324 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (very high risk)- unplanned visit | 0.09 mg/dL | Standard Deviation 0.35 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(low risk)-Week 12 | 0.24 mg/dL | Standard Deviation 2.99 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(low risk)-unplanned visit | -0.98 mg/dL | Standard Deviation 4.594 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(moderate risk)-Week 12 | -0.14 mg/dL | Standard Deviation 3.887 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(moderate risk)-unplanned | 1.91 mg/dL | Standard Deviation 2.925 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(high risk)-Week 12 | 0.20 mg/dL | Standard Deviation 4.841 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (low risk)-unplanned | -70.43 mg/dL | Standard Deviation 46.727 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (moderate risk)-unplanned | -81.23 mg/dL | Standard Deviation 42.498 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (high risk)-unplanned | -56.26 mg/dL | Standard Deviation 39.587 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (very high risk)-week 12 | -25.78 mg/dL | Standard Deviation 49.06 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (very high risk)-unplanned | -40.75 mg/dL | Standard Deviation 37.827 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (low risk)-Week 12 | -0.01 mg/dL | Standard Deviation 0.306 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (low risk)-unplanned | 0.01 mg/dL | Standard Deviation 0.146 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (moderate risk)-Week 12 | 0.00 mg/dL | Standard Deviation 0.108 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (very high risk)- Week 12 | 0.01 mg/dL | Standard Deviation 0.258 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (very high risk)-unplanned | 0.03 mg/dL | Standard Deviation 0.119 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (low risk)- week 12 | -31.41 mg/dL | Standard Deviation 114.297 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(high risk)-unplanned | -0.36 mg/dL | Standard Deviation 5.678 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (very high risk)- unplanned | -19.08 mg/dL | Standard Deviation 85.039 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (low risk)-Week 12 | -0.06 mg/dL | Standard Deviation 0.98 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (low risk)-unplanned | 0.23 mg/dL | Standard Deviation 1.139 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (very high risk)-unplanned | 0.60 mg/dL | Standard Deviation 1.051 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen (Very high risk)- Week 12 | -0.03 mg/dL | Standard Deviation 5.975 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (high risk)- unplanned | -100.9 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (high risk)-unplanned | -0.30 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (high risk)- unplanned visit | 0.08 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (high risk)-week 12 | -40.35 mg/dL | Standard Deviation 44.527 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (high risk)- week 12 | -83.19 mg/dL | Standard Deviation 151.512 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(high risk)-Week 12 | -1.18 mg/dL | Standard Deviation 2.989 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (high risk)- unplanned | 0.01 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (high risk)-unplanned | -37.84 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(high risk)-unplanned | 3.11 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (high risk)-Week 12 | -0.09 mg/dL | Standard Deviation 0.158 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (high risk)- Week 12 | -0.01 mg/dL | Standard Deviation 0.132 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (high risk)-week 12 | -0.07 mg/dL | Standard Deviation 0.795 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (low risk)-Week 12 | 0.32 mg/dL | Standard Deviation 0.933 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (high risk)-week 12 | -0.58 mg/dL | Standard Deviation 1.664 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (low risk)-unplanned | 0.14 mg/dL | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (moderate risk)-Week 12 | -0.05 mg/dL | Standard Deviation 0.081 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (very high risk)-unplanned | 0.08 mg/dL | Standard Deviation 0.062 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (very high risk)- Week 12 | 0.06 mg/dL | Standard Deviation 0.324 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (very high risk)-week 12 | 0.32 mg/dL | Standard Deviation 1.237 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (very high risk)- unplanned visit | -0.36 mg/dL | Standard Deviation 0.19 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (very high risk)- Week 12 | 0.02 mg/dL | Standard Deviation 0.102 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(low risk)-Week 12 | -2.38 mg/dL | Standard Deviation 3.366 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (high risk)- Week 12 | -0.04 mg/dL | Standard Deviation 0.31 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(low risk)-unplanned visit | -3.67 mg/dL | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (low risk)-Week 12 | -94.98 mg/dL | Standard Deviation 71.53 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(moderate risk)-Week 12 | 1.56 mg/dL | Standard Deviation 4.723 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (moderate risk)- Week 12 | -0.09 mg/dL | Standard Deviation 0.245 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (high risk)-Week 12 | 0.00 mg/dL | Standard Deviation 0.12 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin (low risk)- Week 12 | 0.07 mg/dL | Standard Deviation 0.167 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (very high risk)-unplanned | 0.90 mg/dL | Standard Deviation 1.786 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen(high risk)-Week 12 | -0.99 mg/dL | Standard Deviation 3.19 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (high risk)- week 12 | -46.98 mg/dL | Standard Deviation 127.625 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (moderate risk)- week 12 | -18.19 mg/dL | Standard Deviation 61.094 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (very high risk)- week 12 | 4.47 mg/dL | Standard Deviation 217.543 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (low risk)- unplanned | -188.5 mg/dL | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (low risk)-unplanned | -122.8 mg/dL | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (low risk)- week 12 | -14.16 mg/dL | Standard Deviation 35.044 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (high risk)-week 12 | -38.43 mg/dL | Standard Deviation 49.029 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (moderate risk)-Week 12 | -5.28 mg/dL | Standard Deviation 61.38 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | triglycerides (very high risk)- unplanned | -47.79 mg/dL | Standard Deviation 71.981 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (very high risk)-week 12 | -43.16 mg/dL | Standard Deviation 51.923 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (moderate risk)-Week12 | -0.61 mg/dL | Standard Deviation 1.285 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen (Very high risk)- unplanned | 7.43 mg/dL | Standard Deviation 5.237 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | cholesterol (very high risk)-unplanned | -64.29 mg/dL | Standard Deviation 58.435 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | uric acid (low risk)-unplanned | 0.00 mg/dL | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen (Very high risk)- Week 12 | -0.09 mg/dL | Standard Deviation 5.417 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | creatinine (low risk)-Week 12 | 0.01 mg/dL | Standard Deviation 0.007 |
Secondary
Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5%\ 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%\ 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(Low risk-unplanned visit | 3.00 U/L | Standard Deviation 16.793 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(high risk)-unplanned visit | 10.96 U/L | Standard Deviation 62.211 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(Low risk-Week 12 | 15.40 U/L | Standard Deviation 47.148 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(moderate risk)-Week 12 | 0.45 U/L | Standard Deviation 46.688 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(moderate risk)-unplanned visit | 8.00 U/L | — |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(high risk)-Week 12 | -1.99 U/L | Standard Deviation 118.333 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(very high risk)-Week 12 | -102.0 U/L | Standard Deviation 387.028 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(very high risk)-unplanned visit | 31.50 U/L | Standard Deviation 90.246 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(moderate risk)-Week 12 | 0.03 U/L | Standard Deviation 73.412 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(moderate risk)-unplanned visit | 6.76 U/L | Standard Deviation 30.302 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(high risk)-Week 12 | 14.49 U/L | Standard Deviation 209.095 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(high risk)-unplanned visit | 3.17 U/L | Standard Deviation 87.977 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(very high risk)-unplanned visit | -134.0 U/L | Standard Deviation 479.298 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(Low risk-Week 12 | 22.89 U/L | Standard Deviation 135.208 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(Low risk-unplanned visit | 29.41 U/L | Standard Deviation 112.521 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(very high risk)-Week 12 | -132.5 U/L | Standard Deviation 637.616 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(high risk)-unplanned visit | 22.00 U/L | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(high risk)-Week 12 | -7.60 U/L | Standard Deviation 24.572 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(very high risk)-Week 12 | -607.2 U/L | Standard Deviation 800.209 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(high risk)-Week 12 | -0.25 U/L | Standard Deviation 18.669 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(moderate risk)-Week 12 | -363.4 U/L | Standard Deviation 1078.11 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(Low risk-Week 12 | 15.75 U/L | Standard Deviation 22.274 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase | Creatine Kinase(very high risk)-unplanned visit | -335.2 U/L | Standard Deviation 469.795 |
Secondary
Change From Baseline for Clinical Laboratory Overall- ALT and AST
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- week 12 | -1.50 IU/L | Standard Deviation 18.833 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Week 12 | 0.39 IU/L | Standard Deviation 25.362 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Unplanned | -0.04 IU/L | Standard Deviation 11.639 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- unplanned | -0.38 IU/L | Standard Deviation 6.605 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Unplanned | 2.25 IU/L | Standard Deviation 17.861 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Week 12 | 1.60 IU/L | Standard Deviation 27.048 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- week 12 | -5.54 IU/L | Standard Deviation 47.298 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- unplanned | -8.43 IU/L | Standard Deviation 58.715 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Week 12 | 1.40 IU/L | Standard Deviation 8.414 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- unplanned | 9.00 IU/L | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Unplanned | 5.00 IU/L | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- week 12 | 3.60 IU/L | Standard Deviation 2.966 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Week 12 | -0.25 IU/L | Standard Deviation 14.079 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- unplanned | -125.5 IU/L | Standard Deviation 184.247 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- week 12 | -37.78 IU/L | Standard Deviation 87.382 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Unplanned | -20.70 IU/L | Standard Deviation 30.772 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Unplanned | 1.22 IU/L | Standard Deviation 13 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- ALT and AST | ALT-Week 12 | -1.00 IU/L | Standard Deviation 21.058 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- unplanned | 2.22 IU/L | Standard Deviation 10.169 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- ALT and AST | AST- week 12 | -17.48 IU/L | Standard Deviation 61.362 |
Secondary
Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen- unplanned visit | -1.18 mg/dL | Standard Deviation 3.495 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen-Week 12 | 0.16 mg/dL | Standard Deviation 5.238 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Unplanned | -0.01 mg/dL | Standard Deviation 0.301 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- Week 12 | -3.95 mg/dL | Standard Deviation 93.668 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- unplanned visit | -0.29 mg/dL | Standard Deviation 0.859 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- Week 12 | -52.83 mg/dL | Standard Deviation 621.039 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- unplanned | 0.00 mg/dL | Standard Deviation 0.087 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- Week 12 | 0.01 mg/dL | Standard Deviation 0.202 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- unplanned visit | -43.38 mg/dL | Standard Deviation 31.472 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Week 12 | 0.02 mg/dL | Standard Deviation 0.248 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- unplanned | -36.84 mg/dL | Standard Deviation 67.068 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- week 12 | -26.13 mg/dL | Standard Deviation 44.751 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- Week 12 | -27.88 mg/dL | Standard Deviation 108.151 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- unplanned visit | 0.12 mg/dL | Standard Deviation 1.159 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Week 12 | 0.02 mg/dL | Standard Deviation 0.323 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Unplanned | 0.04 mg/dL | Standard Deviation 0.293 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen-Week 12 | 0.10 mg/dL | Standard Deviation 5.001 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen- unplanned visit | -0.08 mg/dL | Standard Deviation 5.326 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- week 12 | -45.15 mg/dL | Standard Deviation 393.221 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- unplanned visit | -55.38 mg/dL | Standard Deviation 41.996 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- Week 12 | 0.01 mg/dL | Standard Deviation 0.224 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- unplanned | 0.01 mg/dL | Standard Deviation 0.13 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- unplanned | -46.19 mg/dL | Standard Deviation 144.402 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- Week 12 | -0.08 mg/dL | Standard Deviation 1.438 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- unplanned visit | -37.84 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen-Week 12 | -1.18 mg/dL | Standard Deviation 2.989 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- unplanned | 0.01 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Week 12 | -0.01 mg/dL | Standard Deviation 0.132 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- Week 12 | -0.07 mg/dL | Standard Deviation 0.795 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- Week 12 | -0.09 mg/dL | Standard Deviation 0.158 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- week 12 | -40.35 mg/dL | Standard Deviation 44.527 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- unplanned visit | -0.30 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen- unplanned visit | 3.11 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Unplanned | 0.08 mg/dL | — |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- Week 12 | -83.19 mg/dL | Standard Deviation 151.512 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- unplanned | -100.9 mg/dL | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Week 12 | 0.00 mg/dL | Standard Deviation 0.301 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- Week 12 | -0.20 mg/dL | Standard Deviation 1.468 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen- unplanned visit | 4.66 mg/dL | Standard Deviation 7.005 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- week 12 | -36.98 mg/dL | Standard Deviation 54.175 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- unplanned visit | -75.98 mg/dL | Standard Deviation 56.967 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- unplanned visit | 0.68 mg/dL | Standard Deviation 1.526 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- unplanned | -75.93 mg/dL | Standard Deviation 88.578 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- Week 12 | 0.00 mg/dL | Standard Deviation 0.106 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- unplanned | 0.09 mg/dL | Standard Deviation 0.06 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- Week 12 | -20.97 mg/dL | Standard Deviation 160.296 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Unplanned | -0.36 mg/dL | Standard Deviation 0.19 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen-Week 12 | -0.29 mg/dL | Standard Deviation 4.417 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- unplanned | -0.05 mg/dL | Standard Deviation 0.131 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- Week 12 | -0.04 mg/dL | Standard Deviation 1.781 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Uric acid- unplanned visit | -0.28 mg/dL | Standard Deviation 0.957 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen- unplanned visit | -1.16 mg/dL | Standard Deviation 3.911 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- week 12 | -27.20 mg/dL | Standard Deviation 38.056 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Blood urea nitrogen-Week 12 | -0.86 mg/dL | Standard Deviation 9.287 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Unplanned | 0.09 mg/dL | Standard Deviation 0.387 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Bilirubin-Week 12 | -0.08 mg/dL | Standard Deviation 0.38 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Creatinine- Week 12 | 0.01 mg/dL | Standard Deviation 0.165 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- unplanned | -25.67 mg/dL | Standard Deviation 39.725 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Cholesterol- unplanned visit | -24.23 mg/dL | Standard Deviation 22.633 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid | Triglycerides- Week 12 | 8.22 mg/dL | Standard Deviation 49.616 |
Secondary
Change From Baseline for Clinical Laboratory Overall- Creatine Kinase
The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Week 12 | -12.77 U/L | Standard Deviation 168.37 |
| Atorvastatin <=10 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Unplanned visit | 12.65 U/L | Standard Deviation 59.88 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Week 12 | -30.49 U/L | Standard Deviation 388.838 |
| Atorvastatin 20 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Unplanned visit | -26.74 U/L | Standard Deviation 256.628 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Week 12 | -7.60 U/L | Standard Deviation 24.572 |
| Atorvastatin 30 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Unplanned visit | 22.00 U/L | — |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Unplanned visit | -335.2 U/L | Standard Deviation 469.795 |
| Atorvastatin 40 mg | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Week 12 | -300.8 U/L | Standard Deviation 698.733 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Week 12 | -139.0 U/L | Standard Deviation 431.288 |
| Atorvastatin Unknown Dosage | Change From Baseline for Clinical Laboratory Overall- Creatine Kinase | Unplanned visit | 23.67 U/L | Standard Deviation 27.609 |
Secondary
Change From Baseline for Lipid Parameters at Week 12 for Overall
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline data was reported.
Time frame: Baseline to Week 12
Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -24.81 milligram/deciliter (mg/dL) | Standard Deviation 43.971 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | 0.55 milligram/deciliter (mg/dL) | Standard Deviation 10.619 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -25.26 milligram/deciliter (mg/dL) | Standard Deviation 35.375 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | -2.69 milligram/deciliter (mg/dL) | Standard Deviation 94.228 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | 0.44 milligram/deciliter (mg/dL) | Standard Deviation 13.643 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -31.47 milligram/deciliter (mg/dL) | Standard Deviation 38.285 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | -27.55 milligram/deciliter (mg/dL) | Standard Deviation 107.785 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -45.12 milligram/deciliter (mg/dL) | Standard Deviation 394.177 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -31.40 milligram/deciliter (mg/dL) | Standard Deviation 34.152 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | 0.13 milligram/deciliter (mg/dL) | Standard Deviation 7.421 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | -83.19 milligram/deciliter (mg/dL) | Standard Deviation 151.512 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -40.35 milligram/deciliter (mg/dL) | Standard Deviation 44.527 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | -20.97 milligram/deciliter (mg/dL) | Standard Deviation 160.296 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | -0.17 milligram/deciliter (mg/dL) | Standard Deviation 8.493 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -36.98 milligram/deciliter (mg/dL) | Standard Deviation 54.175 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -36.00 milligram/deciliter (mg/dL) | Standard Deviation 40.783 |
Secondary
Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline data was reported.
Time frame: Baseline to Week 12
Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol-Low risk | -51.42 mg/dL | Standard Deviation 42.967 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol- High risk | -27.04 mg/dL | Standard Deviation 43.996 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Low risk | -0.29 mg/dL | Standard Deviation 8.445 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Moderate risk | 1.27 mg/dL | Standard Deviation 10.964 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- High risk | -26.61 mg/dL | Standard Deviation 35.093 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol-Moderate risk | -26.97 mg/dL | Standard Deviation 42.807 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol- Very high risk | 4.63 mg/dL | Standard Deviation 31.528 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- High risk | 0.18 mg/dL | Standard Deviation 11.112 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Very high risk | 1.99 mg/dL | Standard Deviation 9.675 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Low risk | -49.29 mg/dL | Standard Deviation 37.689 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Moderate risk | -26.07 mg/dL | Standard Deviation 33.338 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Very high risk | -2.99 mg/dL | Standard Deviation 26.243 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Low risk | -42.92 mg/dL | Standard Deviation 48.34 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Moderate risk | 1.52 mg/dL | Standard Deviation 43.42 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- High risk | -3.85 mg/dL | Standard Deviation 102.165 |
| Atorvastatin <=10 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Very high risk | 23.34 mg/dL | Standard Deviation 113.398 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- High risk | -33.10 mg/dL | Standard Deviation 39.149 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol-Low risk | -47.99 mg/dL | Standard Deviation 56.938 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Very high risk | 1.25 mg/dL | Standard Deviation 14.585 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol-Moderate risk | -43.23 mg/dL | Standard Deviation 49.231 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Moderate risk | -0.92 mg/dL | Standard Deviation 10.398 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- High risk | -29.73 mg/dL | Standard Deviation 116.182 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol- High risk | -56.59 mg/dL | Standard Deviation 552.696 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Very high risk | -25.34 mg/dL | Standard Deviation 102.889 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Moderate risk | -37.50 mg/dL | Standard Deviation 37.162 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol- Very high risk | -25.78 mg/dL | Standard Deviation 49.06 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Moderate risk | -22.32 mg/dL | Standard Deviation 70.978 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- High risk | 0.64 mg/dL | Standard Deviation 14.169 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Very high risk | -23.41 mg/dL | Standard Deviation 35.895 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Low risk | -1.80 mg/dL | Standard Deviation 9.943 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Low risk | -42.37 mg/dL | Standard Deviation 37.719 |
| Atorvastatin 20 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Low risk | -28.67 mg/dL | Standard Deviation 110.49 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol- High risk | -40.35 mg/dL | Standard Deviation 44.527 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- High risk | -31.40 mg/dL | Standard Deviation 34.152 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- High risk | 0.13 mg/dL | Standard Deviation 7.421 |
| Atorvastatin 30 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- High risk | -83.19 mg/dL | Standard Deviation 151.512 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Very high risk | 4.47 mg/dL | Standard Deviation 217.543 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Low risk | -14.16 mg/dL | Standard Deviation 35.044 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol- Very high risk | -43.16 mg/dL | Standard Deviation 51.923 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Moderate risk | 5.06 mg/dL | Standard Deviation 10.908 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- High risk | -46.98 mg/dL | Standard Deviation 127.625 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- High risk | 1.21 mg/dL | Standard Deviation 5.473 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Very high risk | -3.02 mg/dL | Standard Deviation 7.447 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Triglycerides- Moderate risk | -18.19 mg/dL | Standard Deviation 61.094 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Low risk | -74.71 mg/dL | Standard Deviation 53.238 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Moderate risk | -25.91 mg/dL | Standard Deviation 32.562 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- High risk | -34.61 mg/dL | Standard Deviation 44.918 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol-Low risk | -94.98 mg/dL | Standard Deviation 71.53 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol-Moderate risk | -5.28 mg/dL | Standard Deviation 61.38 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol- High risk | -38.43 mg/dL | Standard Deviation 49.029 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (HDL)- Low risk | -8.30 mg/dL | Standard Deviation 24.298 |
| Atorvastatin 40 mg | Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group | Cholesterol (LDL)- Very high risk | -38.05 mg/dL | Standard Deviation 38.867 |
Secondary
Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level
AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atorvastatin <=10 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Low risk | 1 Participants |
| Atorvastatin <=10 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Moderate risk | 3 Participants |
| Atorvastatin <=10 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | High risk | 11 Participants |
| Atorvastatin <=10 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Very high risk | 3 Participants |
| Atorvastatin 20 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Moderate risk | 11 Participants |
| Atorvastatin 20 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | High risk | 81 Participants |
| Atorvastatin 20 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Very high risk | 45 Participants |
| Atorvastatin 20 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Low risk | 9 Participants |
| Atorvastatin 30 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | High risk | 1 Participants |
| Atorvastatin 30 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Moderate risk | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Very high risk | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Low risk | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Very high risk | 3 Participants |
| Atorvastatin 40 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Moderate risk | 1 Participants |
| Atorvastatin 40 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | Low risk | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level | High risk | 1 Participants |
Secondary
Number of Participants With Adverse Events of Special Interest (AESI) for Overall
AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atorvastatin <=10 mg | Number of Participants With Adverse Events of Special Interest (AESI) for Overall | 18 Participants |
| Atorvastatin 20 mg | Number of Participants With Adverse Events of Special Interest (AESI) for Overall | 146 Participants |
| Atorvastatin 30 mg | Number of Participants With Adverse Events of Special Interest (AESI) for Overall | 1 Participants |
| Atorvastatin 40 mg | Number of Participants With Adverse Events of Special Interest (AESI) for Overall | 5 Participants |
| Atorvastatin Unknown Dosage | Number of Participants With Adverse Events of Special Interest (AESI) for Overall | 7 Participants |
Secondary
Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk
The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Moderate risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Very high risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Low risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Low risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (High risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (High risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Low risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (High risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (High risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Low risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Low risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Low risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (High risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Very high risk) | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (High risk) | 1 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Low risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (High risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Low risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (High risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Low risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (High risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Very high risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Low risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Low risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (High risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Very high risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (High risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (Very high risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | AST>3*ULN (High risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | ALT>3*ULN (Moderate risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk | CK >= 10*ULN (Low risk) | 0 Participants |
Secondary
Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall
The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range.
Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | ALT>3*ULN | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | CK >= 10*ULN | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | AST>3*ULN | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | AST>3*ULN | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | ALT>3*ULN | 0 Participants |
| Atorvastatin 20 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | CK >= 10*ULN | 1 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | AST>3*ULN | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | ALT>3*ULN | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | CK >= 10*ULN | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | ALT>3*ULN | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | CK >= 10*ULN | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | AST>3*ULN | 0 Participants |
| Atorvastatin Unknown Dosage | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | AST>3*ULN | 0 Participants |
| Atorvastatin Unknown Dosage | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | ALT>3*ULN | 0 Participants |
| Atorvastatin Unknown Dosage | Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall | CK >= 10*ULN | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level
All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Low risk) | 1 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Moderate risk) | 8 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (High risk) | 22 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Very high risk) | 5 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Low risk) | 0 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Moderate risk) | 3 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (High risk) | 10 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Very high risk) | 4 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Moderate risk) | 9 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Low risk) | 7 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Moderate risk) | 27 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Very high risk) | 25 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (High risk) | 66 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Very high risk) | 70 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (High risk) | 126 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Low risk) | 18 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (High risk) | 1 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (High risk) | 1 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Very high risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Low risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Moderate risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Very high risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Low risk) | 0 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Moderate risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (High risk) | 1 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Very high risk) | 4 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Moderate risk) | 1 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | All causalities (Low risk) | 1 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Low risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Very high risk) | 1 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (High risk) | 0 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level | Treatment-related (Moderate risk) | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall
All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.
Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | Treatment-related | 17 Participants |
| Atorvastatin <=10 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | All causalities | 36 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | All causalities | 241 Participants |
| Atorvastatin 20 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | Treatment-related | 107 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | All causalities | 1 Participants |
| Atorvastatin 30 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | Treatment-related | 1 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | Treatment-related | 2 Participants |
| Atorvastatin 40 mg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | All causalities | 7 Participants |
| Atorvastatin Unknown Dosage | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | All causalities | 19 Participants |
| Atorvastatin Unknown Dosage | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall | Treatment-related | 6 Participants |
Secondary
Percent Change From Baseline for Lipid Parameters at Week 12 for Overall
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.
Time frame: Baseline to Week 12
Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -17.40 Percent Change (%) | Standard Deviation 32.437 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | 3.68 Percent Change (%) | Standard Deviation 26.013 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -9.96 Percent Change (%) | Standard Deviation 24.219 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | 12.03 Percent Change (%) | Standard Deviation 82.582 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -13.66 Percent Change (%) | Standard Deviation 34.091 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -20.11 Percent Change (%) | Standard Deviation 50.643 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | -4.04 Percent Change (%) | Standard Deviation 52.636 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | 4.18 Percent Change (%) | Standard Deviation 25.386 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | -27.55 Percent Change (%) | Standard Deviation 33.921 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -17.33 Percent Change (%) | Standard Deviation 19.989 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | 1.52 Percent Change (%) | Standard Deviation 15.985 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -22.57 Percent Change (%) | Standard Deviation 26.524 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (LDL) | -23.68 Percent Change (%) | Standard Deviation 25.476 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol (HDL) | 0.91 Percent Change (%) | Standard Deviation 15.835 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Cholesterol | -3.07 Percent Change (%) | Standard Deviation 104.388 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 for Overall | Triglycerides | -12.33 Percent Change (%) | Standard Deviation 34.679 |
Secondary
Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level
Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.
Time frame: Baseline to Week 12
Population: The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- moderate risk | -11.66 Percent Change | Standard Deviation 23.157 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- moderate risk | 4.08 Percent Change | Standard Deviation 20.094 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- very high risk | 6.09 Percent Change | Standard Deviation 22.562 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- low risk | -21.06 Percent Change | Standard Deviation 18.145 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- high risk | 3.41 Percent Change | Standard Deviation 29.176 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- high risk | 13.35 Percent Change | Standard Deviation 92.014 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- moderate risk | -18.59 Percent Change | Standard Deviation 29.052 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- high risk | -11.53 Percent Change | Standard Deviation 24.302 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- very high risk | 6.02 Percent Change | Standard Deviation 22.796 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- very high risk | 0.78 Percent Change | Standard Deviation 34.076 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- high risk | -19.16 Percent Change | Standard Deviation 32.501 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- low risk | -31.33 Percent Change | Standard Deviation 26.408 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- moderate risk | 3.98 Percent Change | Standard Deviation 40.156 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- very high risk | 36.01 Percent Change | Standard Deviation 89.326 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- low risk | -21.40 Percent Change | Standard Deviation 32.03 |
| Atorvastatin <=10 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL) - low risk | 1.21 Percent Change | Standard Deviation 15.236 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- moderate risk | 0.29 Percent Change | Standard Deviation 18.265 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- very high risk | -12.68 Percent Change | Standard Deviation 79.286 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- very high risk | -11.07 Percent Change | Standard Deviation 29.007 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- low risk | -9.65 Percent Change | Standard Deviation 39.61 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- moderate risk | -8.81 Percent Change | Standard Deviation 39.316 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- high risk | -3.77 Percent Change | Standard Deviation 50.582 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL) - low risk | -1.55 Percent Change | Standard Deviation 17.047 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- very high risk | -1.17 Percent Change | Standard Deviation 62.412 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- moderate risk | -18.50 Percent Change | Standard Deviation 24.651 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- high risk | 4.59 Percent Change | Standard Deviation 25.053 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- very high risk | 6.55 Percent Change | Standard Deviation 29.457 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- high risk | -13.91 Percent Change | Standard Deviation 34.085 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- low risk | -27.43 Percent Change | Standard Deviation 22.633 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- moderate risk | -27.12 Percent Change | Standard Deviation 27.917 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- low risk | -15.39 Percent Change | Standard Deviation 53.309 |
| Atorvastatin 20 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- high risk | -21.81 Percent Change | Standard Deviation 31.964 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- high risk | -22.57 Percent Change | Standard Deviation 26.524 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- high risk | -17.33 Percent Change | Standard Deviation 19.989 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- high risk | 1.52 Percent Change | Standard Deviation 15.985 |
| Atorvastatin 30 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- high risk | -27.55 Percent Change | Standard Deviation 33.921 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- very high risk | -10.55 Percent Change | Standard Deviation 36.114 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- low risk | -36.33 Percent Change | Standard Deviation 23.292 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- moderate risk | 73.60 Percent Change | Standard Deviation 253.741 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- high risk | -15.34 Percent Change | Standard Deviation 18.104 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol- very high risk | -18.58 Percent Change | Standard Deviation 24.524 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL) - low risk | -7.03 Percent Change | Standard Deviation 35.153 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- moderate risk | 12.12 Percent Change | Standard Deviation 22.325 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- high risk | 2.42 Percent Change | Standard Deviation 11.126 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (HDL)- very high risk | -4.53 Percent Change | Standard Deviation 13.6 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- low risk | -47.37 Percent Change | Standard Deviation 30.298 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- moderate risk | -20.86 Percent Change | Standard Deviation 24.354 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- high risk | -20.59 Percent Change | Standard Deviation 26.181 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Cholesterol (LDL)- very high risk | -25.92 Percent Change | Standard Deviation 25.288 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- low risk | -9.63 Percent Change | Standard Deviation 32.475 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- moderate risk | -10.93 Percent Change | Standard Deviation 37.268 |
| Atorvastatin 40 mg | Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level | Triglycerides- high risk | -14.81 Percent Change | Standard Deviation 34.606 |
Secondary
Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level
Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: 12 weeks of follow-up
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Low risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Moderate risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (High risk) | 0.57 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Low risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (High risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Very high risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Low risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Moderate risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined(Very high risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Very high risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (High risk) | 1.14 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Low risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Very high risk) | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (High risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Very high risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Very high risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Moderate risk) | 2.43 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Low risk) | 0.36 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Low risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Low risk) | 0.36 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (High risk) | 0.06 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (High risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (High risk) | 1.07 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (High risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Moderate risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Very high risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined(Very high risk) | 0.97 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Low risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Low risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (High risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (High risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (High risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (High risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Very high risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined(Very high risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Very high risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Very high risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Low risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Low risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Low risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Moderate risk) | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Moderate risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (High risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Low risk) | 0.32 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Very high risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined(Very high risk) | 2.00 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Moderate risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Low risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Very high risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (High risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Moderate risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (High risk) | 2.70 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (Low risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Moderate risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Relation to study drug not defined (Low risk) | 20.0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Death (High risk) | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level | Not related to study drug (Very high risk) | 0 Percent |
Secondary
Precentage of Participants With Discontinuation From the Study for Overall
Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.
Time frame: 12 weeks of follow-up
Population: The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Related to study drug | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study for Overall | Death | 0 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study for Overall | Relation to study drug not defined | 0.68 Percent |
| Atorvastatin <=10 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Not related to study drug | 0.34 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study for Overall | Relation to study drug not defined | 1.10 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study for Overall | Death | 0.03 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Related to study drug | 0.03 Percent |
| Atorvastatin 20 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Not related to study drug | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study for Overall | Death | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Not related to study drug | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study for Overall | Relation to study drug not defined | 0 Percent |
| Atorvastatin 30 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Related to study drug | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study for Overall | Death | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Not related to study drug | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study for Overall | AE Related to study drug | 0 Percent |
| Atorvastatin 40 mg | Precentage of Participants With Discontinuation From the Study for Overall | Relation to study drug not defined | 2.97 Percent |
| Atorvastatin Unknown Dosage | Precentage of Participants With Discontinuation From the Study for Overall | Relation to study drug not defined | 96.77 Percent |
| Atorvastatin Unknown Dosage | Precentage of Participants With Discontinuation From the Study for Overall | Death | 0.37 Percent |
| Atorvastatin Unknown Dosage | Precentage of Participants With Discontinuation From the Study for Overall | AE Not related to study drug | 0.37 Percent |
| Atorvastatin Unknown Dosage | Precentage of Participants With Discontinuation From the Study for Overall | AE Related to study drug | 0.47 Percent |
Secondary
Study Drug Exposure for Overall - Daily Dose
Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.
Time frame: Day 1 to Week 12
Population: The analysis set included all participants who received at least 1 dose of atorvastatin and evaluable for specified category (daily dose).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin <=10 mg | Study Drug Exposure for Overall - Daily Dose | 10.43 mg/day | Standard Deviation 1.633 |
| Atorvastatin 20 mg | Study Drug Exposure for Overall - Daily Dose | 20.00 mg/day | Standard Deviation 0.423 |
| Atorvastatin 30 mg | Study Drug Exposure for Overall - Daily Dose | 29.00 mg/day | Standard Deviation 2.646 |
| Atorvastatin 40 mg | Study Drug Exposure for Overall - Daily Dose | 39.96 mg/day | Standard Deviation 0.314 |
| Atorvastatin Unknown Dosage | Study Drug Exposure for Overall - Daily Dose | 20.09 mg/day | Standard Deviation 3.74 |
Secondary
Study Drug Exposure for Overall - Total Dose and Week 12 Dose
Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12
Time frame: Day 1 to Week 12
Population: The analysis set included all participants who received at least 1 dose of atorvastatin. Atorvastatin Unknown Dosage did not have Week 12 dose. Number analyzed refers to number of participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Total dose | 958.90 mg | Standard Deviation 240.812 |
| Atorvastatin <=10 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Week 12 dose | 9.96 mg | Standard Deviation 0.422 |
| Atorvastatin 20 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Week 12 dose | 20.00 mg | Standard Deviation 0 |
| Atorvastatin 20 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Total dose | 1816.63 mg | Standard Deviation 376.664 |
| Atorvastatin 30 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Week 12 dose | 30.00 mg | Standard Deviation 0 |
| Atorvastatin 30 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Total dose | 2506.19 mg | Standard Deviation 314.555 |
| Atorvastatin 40 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Week 12 dose | 40.00 mg | Standard Deviation 0 |
| Atorvastatin 40 mg | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Total dose | 3326.93 mg | Standard Deviation 631.053 |
| Atorvastatin Unknown Dosage | Study Drug Exposure for Overall - Total Dose and Week 12 Dose | Total dose | 178.90 mg | Standard Deviation 136.33 |
Secondary
Study Drug Exposure Within Each CVD Risk Group -Daily Dose
Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Day 1 to Week 12
Population: The analysis set included all participants who received at least 1 dose of atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (High risk) | 10.39 mg/day | Standard Deviation 1.678 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Moderate risk) | 10.53 mg/day | Standard Deviation 1.572 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Very high risk) | 10.29 mg/day | Standard Deviation 1.486 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Low risk) | 10.81 mg/day | Standard Deviation 1.721 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Low risk) | 20.00 mg/day | Standard Deviation 0 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Very high risk) | 20.00 mg/day | Standard Deviation 0.136 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Moderate risk) | 20.03 mg/day | Standard Deviation 0.719 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (High risk) | 20.00 mg/day | Standard Deviation 0.508 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (High risk) | 28.38 mg/day | Standard Deviation 3.254 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Low risk) | 30.00 mg/day | — |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Very high risk) | 30.00 mg/day | Standard Deviation 0 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Moderate risk) | 30.00 mg/day | Standard Deviation 0 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Very high risk) | 39.94 mg/day | Standard Deviation 0.424 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Low risk) | 40.00 mg/day | Standard Deviation 0 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (Moderate risk) | 40.00 mg/day | Standard Deviation 0 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group -Daily Dose | Daily dose (High risk) | 39.97 mg/day | Standard Deviation 0.164 |
Secondary
Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose
Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk \<5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.
Time frame: Day 1 to Week 12
Population: The analysis set included all participants who received at least 1 dose of atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Very high risk) | 964.04 mg | Standard Deviation 152.396 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose(Moderate risk) | 10.00 mg | Standard Deviation 0 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Low risk) | 975.00 mg | Standard Deviation 312.567 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Very high risk) | 10.00 mg | Standard Deviation 0 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Moderate risk) | 914.47 mg | Standard Deviation 224.965 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (High risk) | 964.63 mg | Standard Deviation 254.036 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Low risk) | 10.00 mg | Standard Deviation 0 |
| Atorvastatin <=10 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (High risk) | 10.39 mg | Standard Deviation 1.678 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Very high risk) | 1804.61 mg | Standard Deviation 328.691 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Low risk) | 20.00 mg | Standard Deviation 0 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose(Moderate risk) | 20.00 mg | Standard Deviation 0 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Very high risk) | 20.00 mg | Standard Deviation 0 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Moderate risk) | 1781.18 mg | Standard Deviation 415.197 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (High risk) | 1842.03 mg | Standard Deviation 383.312 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Low risk) | 1760.84 mg | Standard Deviation 449.801 |
| Atorvastatin 20 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (High risk) | 20.00 mg | Standard Deviation 0.508 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Low risk) | 2790.00 mg | — |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Moderate risk) | 2542.50 mg | Standard Deviation 261.964 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (High risk) | 2419.23 mg | Standard Deviation 342.332 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Very high risk) | 2740.00 mg | Standard Deviation 96.437 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Low risk) | 30.00 mg | — |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose(Moderate risk) | 30.00 mg | Standard Deviation 0 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (High risk) | 28.38 mg | Standard Deviation 3.254 |
| Atorvastatin 30 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Very high risk) | 30.00 mg | Standard Deviation 0 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (High risk) | 3525.95 mg | Standard Deviation 373.954 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Moderate risk) | 3524.44 mg | Standard Deviation 464.519 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Very high risk) | 40.00 mg | Standard Deviation 0 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (High risk) | 39.97 mg | Standard Deviation 0.164 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Low risk) | 3456.00 mg | Standard Deviation 1245.986 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose (Low risk) | 40.00 mg | Standard Deviation 0 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Total dose (Very high risk) | 3131.20 mg | Standard Deviation 685.669 |
| Atorvastatin 40 mg | Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose | Week 12 dose(Moderate risk) | 40.00 mg | Standard Deviation 0 |