Dyslipidemias
Conditions
Brief summary
To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.
Interventions
DRUGAtorvastatin
Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Is a Korean , dyslipidemic outpatient 2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk \< 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk \> 20 %) 3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline
Exclusion criteria
1. Is pregnant or lactating 2. Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis 3. Has history of intolerance or hypersensitivity to atorvastatin or other statins 4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg) 5. Has HbAlc \> 10% 6. Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. | Week 8 | LDL-C Responders by visit and by risk group - full analysis set (FAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Weeks 4 and 8 | Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride |
| Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | weeks 4 and 8 | Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride |
| Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | 8 weeks | LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF) |
| Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | 8 weeks | LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF) |
| Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. | Week 4 | LDL-C Responders by visit and by risk group - FAS |
| Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | 4 and 8 weeks | Percent change from baseline in hs-CRP by risk group - FAS |
| Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | Baseline, and 8 weeks | Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS |
| Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | 8 weeks | Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS |
| Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | 4 and 8 weeks | Median baseline, and change from baseline in hs-CRP by risk group - FAS |
Countries
South Korea
Participant flow
Recruitment details
Study was conducted at 20 centers in Korea
Pre-assignment details
Participants who were on antilipidemic medications at the time of screening required a 6-week washout period prior to study treatment
Participants by arm
| Arm | Count |
|---|---|
| Total Treatment Group (All Subjects Who Received Atorvastatin) this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors | 425 |
| Total | 425 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse event not related to study drug | 7 |
| Overall Study | Adverse event related to study drug | 10 |
| Overall Study | Protocol violation, & subject schedule | 12 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Total Treatment Group (All Subjects Who Received Atorvastatin) |
|---|---|
| Age, Continuous Females between 18 and 80 years | 62.9 Years STANDARD_DEVIATION 8.6 |
| Age, Continuous Males between 18 and 80 years | 58.6 Years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 195 Participants |
| Sex: Female, Male Male | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / — |
| serious Total, serious adverse events | 3 / — |
Outcome results
Primary
Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.
LDL-C Responders by visit and by risk group - full analysis set (FAS)
Time frame: Week 8
Population: N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total | Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. | 86.0 Percentage of participants |
| Low Risk | Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. | 92.9 Percentage of participants |
| Medium Risk | Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. | 95.5 Percentage of participants |
| High Risk | Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. | 84.3 Percentage of participants |
Secondary
Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Median baseline, and change from baseline in hs-CRP by risk group - FAS
Time frame: 4 and 8 weeks
Population: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Baseline | 0.108 mg/dL |
| Total | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 8) | -0.015 mg/dL |
| Total | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 4) | -0.008 mg/dL |
| Low Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Baseline | 0.082 mg/dL |
| Low Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 8) | -0.011 mg/dL |
| Low Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 4) | -0.008 mg/dL |
| Medium Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 4) | -0.002 mg/dL |
| Medium Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Baseline | 0.075 mg/dL |
| Medium Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 8) | -0.001 mg/dL |
| High Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Baseline | 0.122 mg/dL |
| High Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 8) | -0.018 mg/dL |
| High Risk | Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median change from baseline (week 4) | -0.010 mg/dL |
Secondary
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
Time frame: Baseline, and 8 weeks
Population: Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 baseline | 302.7 pg/dL |
| Total | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 change from baseline (week 8) | 39.8 pg/dL |
| Total | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 baseline | 0.40 pg/dL |
| Total | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 change from baseline (week 8) | 0.00 pg/dL |
| Total | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha baseline | 0.10 pg/dL |
| Total | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha change from baseline (week 8) | 0.00 pg/dL |
| Low Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha change from baseline (week 8) | 0.00 pg/dL |
| Low Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 change from baseline (week 8) | 0.00 pg/dL |
| Low Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 baseline | 305.2 pg/dL |
| Low Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 baseline | 0.30 pg/dL |
| Low Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 change from baseline (week 8) | -15.0 pg/dL |
| Low Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha baseline | 0.10 pg/dL |
| Medium Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 change from baseline (week 8) | -22.4 pg/dL |
| Medium Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 baseline | 0.40 pg/dL |
| Medium Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 change from baseline (week 8) | -0.10 pg/dL |
| Medium Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha change from baseline (week 8) | 0.00 pg/dL |
| Medium Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha baseline | 0.20 pg/dL |
| Medium Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 baseline | 317.7 pg/dL |
| High Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha baseline | 0.10 pg/dL |
| High Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha change from baseline (week 8) | 0.00 pg/dL |
| High Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 change from baseline (week 8) | 59.4 pg/dL |
| High Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 change from baseline (week 8) | 0.00 pg/dL |
| High Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 baseline | 301.6 pg/dL |
| High Risk | Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 baseline | 0.50 pg/dL |
Secondary
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Time frame: Weeks 4 and 8
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio baseline | 3.2 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 8) | -70.7 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 8) | 0.5 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 8) | -29.3 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 4) | -69.4 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C baseline | 175.5 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG baseline | 154.1 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 8) | -70.4 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 8) | -65.3 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C baseline | 151.7 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 4) | -69.4 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC baseline | 223.9 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C baseline | 48.3 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 4) | -29.1 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 8 | -1.4 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 4 | -1.4 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 4) | 0.1 mg/dL (ratio for Scalar) |
| Total | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 4) | -63.5 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 8) | -77.6 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C baseline | 187.0 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 4) | -73.8 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C baseline | 50.5 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 4) | -0.8 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 8) | 2.1 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C baseline | 209.9 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 4) | -75.4 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 8) | -80.9 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio baseline | 3.7 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 4 | -1.4 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 8 | -1.6 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC baseline | 262.3 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 4) | -78.2 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 8) | -80.7 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG baseline | 150.7 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 4) | -11.5 mg/dL (ratio for Scalar) |
| Low Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 8) | -20.9 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 4) | 3.3 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio baseline | 3.4 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 4 | -1.5 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C baseline | 48.0 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 8) | -18.5 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 8 | -1.5 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 4) | -16.6 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC baseline | 235.1 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 8) | -64.2 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 4) | -68.0 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C baseline | 160.6 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 8) | -69.1 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 4) | -65.1 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C baseline | 187.1 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 8) | 3.0 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 4) | -71.3 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG baseline | 152.3 mg/dL (ratio for Scalar) |
| Medium Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 8) | -72.1 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C baseline | 171.1 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG baseline | 154.7 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 4) | -68.8 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio baseline | 3.2 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C baseline | 48.2 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C baseline | 147.7 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 4) | -62.4 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 4 | -1.3 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 4) | -0.2 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 8) | -31.4 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC (week 8) | -69.7 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C Ratio (Scalar) week 8 | -1.4 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C (week 8) | -64.4 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C (week 8) | 0.0 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 8) | -69.7 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC baseline | 219.3 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C (week 4) | -68.6 mg/dL (ratio for Scalar) |
| High Risk | Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG (week 4) | -32.1 mg/dL (ratio for Scalar) |
Secondary
Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Percent change from baseline in hs-CRP by risk group - FAS
Time frame: 4 and 8 weeks
Population: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 4) | -12.346 percentage |
| Total | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 8) | -18.605 percentage |
| Low Risk | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 8) | -18.621 percentage |
| Low Risk | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 4) | -13.941 percentage |
| Medium Risk | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 4) | -2.553 percentage |
| Medium Risk | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 8) | -1.472 percentage |
| High Risk | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 4) | -16.197 percentage |
| High Risk | Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment | Median % change from baseline (week 8) | -20.561 percentage |
Secondary
Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Time frame: weeks 4 and 8
Population: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 8) | -30.7 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 8) | -9.8 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 8) | -42.6 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 4) | -40.9 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 4) | -30.3 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 4) | 1.7 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 8) | 2.6 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 8) | -42.0 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 4) | -8.2 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 4) | -38.7 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 8) | -39.4 Percent |
| Total | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 4) | -41.3 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 8) | -41.2 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 4) | -36.7 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 8) | 5.6 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 4) | -29.7 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 8) | -30.4 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 8) | -41.6 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 4) | -39.5 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 8) | -38.2 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 4) | -35.5 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 4) | -0.2 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 8) | -6.3 Percent |
| Low Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 4) | 4.4 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 8) | -42.9 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 4) | -39.6 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 8) | -39.3 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 4) | 7.7 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 8) | 6.7 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 4) | -37.7 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 8) | -38.3 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 4) | -44.1 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 4) | -28.5 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 8) | -29.2 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 4) | -8.3 Percent |
| Medium Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 8) | -7.0 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 8) | -39.7 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | Non-HDL-C % change from baseline (week 4) | -39.1 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 4) | -41.2 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 8) | -31.0 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 8) | 1.8 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | HDL-C % change from baseline (week 4) | 1.1 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 8) | -10.5 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TG % change from baseline (week 4) | -9.3 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 8) | -42.6 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C/HDL-C ratio % change from baseline (week 4) | -41.4 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | LDL-C % change from baseline (week 8) | -42.5 Percent |
| High Risk | Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment | TC % change from baseline (week 4) | -30.6 Percent |
Secondary
Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
Time frame: 8 weeks
Population: Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 % change (week 8) | 14.0 percent |
| Total | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha % change (week 8) | 0.00 percent |
| Total | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 % change (week 8) | 0.00 percent |
| Low Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 % change (week 8) | -5.6 percent |
| Low Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha % change (week 8) | 0.00 percent |
| Low Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 % change (week 8) | 0.00 percent |
| Medium Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 % change (week 8) | -12.50 percent |
| Medium Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 % change (week 8) | -8.0 percent |
| Medium Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha % change (week 8) | 0.00 percent |
| High Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | MCP-1 % change (week 8) | 18.2 percent |
| High Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | TNF-alpha % change (week 8) | 0.00 percent |
| High Risk | Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. | IL-6 % change (week 8) | 0.00 percent |
Secondary
Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.
LDL-C Responders by visit and by risk group - FAS
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total | Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. | 81.9 Percent subjects achieved LDL-C target |
| Low Risk | Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. | 85.7 Percent subjects achieved LDL-C target |
| Medium Risk | Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. | 95.5 Percent subjects achieved LDL-C target |
| High Risk | Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. | 79.9 Percent subjects achieved LDL-C target |
Secondary
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Time frame: 8 weeks
Population: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Total | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, no titration | 89.1 percentage of participants |
| Total | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, 1-step titration | 82.1 percentage of participants |
| Total | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, no titration | 91.1 percentage of participants |
| Total | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, 1-step titration | 83.0 percentage of participants |
| Total | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), no titration | 89.0 percentage of participants |
| Total | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), 1-step titration | 82.1 percentage of participants |
| Low Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), 1-step titration | 100.0 percentage of participants |
| Low Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, 1-step titration | 100.0 percentage of participants |
| Low Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, no titration | 95.8 percentage of participants |
| Low Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, no titration | 95.5 percentage of participants |
| Low Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, 1-step titration | 100.0 percentage of participants |
| Low Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), no titration | 95.8 percentage of participants |
| Medium Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, 1-step titration | 100.0 percentage of participants |
| Medium Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, no titration | 97.4 percentage of participants |
| Medium Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, 1-step titration | 100.0 percentage of participants |
| Medium Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), 1-step titration | 100.0 percentage of participants |
| Medium Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), no titration | 97.6 percentage of participants |
| Medium Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, no titration | 97.6 percentage of participants |
| High Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), no titration | 87.1 percentage of participants |
| High Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF), 1-step titration | 80.8 percentage of participants |
| High Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, 1-step titration | 80.8 percentage of participants |
| High Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, 1-step titration | 81.6 percentage of participants |
| High Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population, no titration | 87.2 percentage of participants |
| High Risk | Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population, no titration | 89.8 percentage of participants |
Secondary
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Time frame: 8 weeks
Population: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) no titration | 336 Participants |
| Total | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders 1-step titration | 56 Participants |
| Total | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) 1-step titration | 56 Participants |
| Total | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders no titration | 305 Participants |
| Total | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders 1-step titration | 53 Participants |
| Total | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders no titration | 339 Participants |
| Low Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders no titration | 22 Participants |
| Low Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders no titration | 24 Participants |
| Low Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) no titration | 24 Participants |
| Low Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders 1-step titration | 3 Participants |
| Low Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) 1-step titration | 3 Participants |
| Low Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders 1-step titration | 3 Participants |
| Medium Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) 1-step titration | 1 Participants |
| Medium Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders 1-step titration | 1 Participants |
| Medium Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders 1-step titration | 1 Participants |
| Medium Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders no titration | 39 Participants |
| Medium Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders no titration | 41 Participants |
| Medium Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) no titration | 41 Participants |
| High Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) 1-step titration | 52 Participants |
| High Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders no titration | 274 Participants |
| High Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population responders 1-step titration | 52 Participants |
| High Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders no titration | 244 Participants |
| High Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | EVAL population responders 1-step titration | 49 Participants |
| High Risk | Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. | FAS population (no LOCF) no titration | 271 Participants |