Hypercholesterolemia, Hypertension
Conditions
Brief summary
To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.
Interventions
Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)
Exclusion criteria
* Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment. * Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 | Baseline, Month 12 | Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 | Baseline, Month 12 | European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12). |
| European SCORE 10-year Risk of Fatal CVD at Month 4 | Baseline, Month 4 | European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4). |
| Framingham 10-year Risk of Stroke at Month 12 | Baseline, Month 12 | Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12). |
| Framingham 10-year Risk of Stroke at Month 4 | Baseline, Month 4 | Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12). |
| Change From Baseline in Framingham 10-year Risk of Developing Total CHD | Baseline, Month 4, Month 12 | Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline. |
| Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | Month 4, Month 12 | Goal set at \<100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at \<80 mg/dL according to the European (EU) Society of Cardiology guidelines. |
| Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | Baseline, Month 4, Month 12 | European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline. |
| Mean Systolic and Diastolic Blood Pressure at Month 4 | Month 4 | — |
| Mean Systolic and Diastolic Blood Pressure at Month 12 | Month 12 | — |
| Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 | Baseline, Month 4 | — |
| Framingham 10-year Risk of Total CHD at Month 4 | Baseline, Month 4 | Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4). |
| Change From Baseline in SBP at Month 12 | Baseline, Month 12 | — |
| Change From Baseline in DBP at Month 12 | Baseline, Month 12 | — |
| Mean Lipid Parameters at Month 4 | Month 4 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. |
| Mean Lipid Parameters at Month 12 | Month 12 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. |
| Change From Baseline in Lipid Parameters at Month 4 | Baseline, Month 4 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline. |
| Change From Baseline in Lipid Parameters at Month 12 | Baseline, Month 12 | Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. |
| Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | Month 4, Month 12 | Goals set at \<140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and \<140/90 mm Hg or \<130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines. |
| Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4, Month 12 | Treatments indicative of prescribed medications other than study provided Caduet. |
| Number of Participants With Increase of Treatment Dosages After 4 Months. | Month 4 | Treatments indicative of prescribed medications other than study provided Caduet. |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 | Baseline, Month 4 | — |
Countries
Costa Rica, Croatia, Czechia, Dominican Republic, Indonesia, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Panama, Philippines, Russia, Saudi Arabia, South Korea, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, Venezuela
Participant flow
Recruitment details
This was a cluster randomized study: the unit of randomization was the investigator, ie, participants were screened before the investigator was randomized. A total of 136 sites were cluster randomized.
Pre-assignment details
Prior to group assignment of investigators (who were the unit of randomization), participants were consented and screened for enrollment eligibility; participant selection for enrollment took place before investigator assignment. A total of 1,531 participants were enrolled and attended baseline visit; 1,461 participants received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Caduet as Assigned Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion. | 783 |
| Usual Care as Assigned Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice. | 678 |
| Total | 1,461 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 36 | 0 |
| Overall Study | Death | 5 | 2 |
| Overall Study | Lost to Follow-up | 12 | 19 |
| Overall Study | Other | 6 | 7 |
| Overall Study | Withdrawal by Subject | 34 | 16 |
Baseline characteristics
| Characteristic | Caduet as Assigned | Usual Care as Assigned | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 58 participants | 55 participants | 113 participants |
| Age, Customized < 18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized 45 to 64 years | 450 participants | 361 participants | 811 participants |
| Age, Customized > = 65 years | 275 participants | 262 participants | 537 participants |
| Sex: Female, Male Female | 368 Participants | 334 Participants | 702 Participants |
| Sex: Female, Male Male | 415 Participants | 344 Participants | 759 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 356 / 779 | 289 / 682 |
| serious Total, serious adverse events | 51 / 779 | 22 / 682 |
Outcome results
Primary
Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Time frame: Baseline, Month 12
Population: Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caduet | Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 | 12.5 percent risk | Standard Deviation 8.26 |
| Usual Care | Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 | 16.3 percent risk | Standard Deviation 10.51 |
Comparison: It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.p-value: <0.00195% CI: [-5.55, -3.89]Mixed-effect linear model
Secondary
Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.
Time frame: Baseline, Month 4, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Caduet | Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | Month 4 | -1.8438 percent risk |
| Caduet | Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | Month 12 | -1.9693 percent risk |
| Usual Care | Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | Month 4 | -0.9678 percent risk |
| Usual Care | Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD | Month 12 | -0.9963 percent risk |
Secondary
Change From Baseline in DBP at Month 12
Time frame: Baseline, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Caduet | Change From Baseline in DBP at Month 12 | -10.0128 mmHg |
| Usual Care | Change From Baseline in DBP at Month 12 | -6.8429 mmHg |
p-value: <0.00195% CI: [-4.42, -1.92]Mixed-effect linear model
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4
Time frame: Baseline, Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Caduet | Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 | -8.3024 mmHG |
| Usual Care | Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4 | -6.6908 mmHG |
p-value: <0.01195% CI: [-2.86, -0.37]Mixed-effect linear model
Secondary
Change From Baseline in Framingham 10-year Risk of Developing Total CHD
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.
Time frame: Baseline, Month 4, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Caduet | Change From Baseline in Framingham 10-year Risk of Developing Total CHD | Month 4 | -7.2705 percent risk |
| Caduet | Change From Baseline in Framingham 10-year Risk of Developing Total CHD | Month 12 | -7.2374 percent risk |
| Usual Care | Change From Baseline in Framingham 10-year Risk of Developing Total CHD | Month 4 | -2.5155 percent risk |
| Usual Care | Change From Baseline in Framingham 10-year Risk of Developing Total CHD | Month 12 | -2.5167 percent risk |
Secondary
Change From Baseline in Lipid Parameters at Month 12
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Time frame: Baseline, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Caduet | Change From Baseline in Lipid Parameters at Month 12 | TC | -37.1024 mg/dL |
| Caduet | Change From Baseline in Lipid Parameters at Month 12 | LDL | -33.2420 mg/dL |
| Caduet | Change From Baseline in Lipid Parameters at Month 12 | HDL | -0.4339 mg/dL |
| Caduet | Change From Baseline in Lipid Parameters at Month 12 | Triglycerides | -15.2270 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 12 | Triglycerides | 3.0398 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 12 | TC | -4.0368 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 12 | HDL | -1.0105 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 12 | LDL | -3.4168 mg/dL |
Comparison: Total cholesterolp-value: <0.00195% CI: [-37.57, -28.56]Mixed-effect linear model
Comparison: LDLp-value: <0.00195% CI: [-33.7, -25.95]Mixed-effect linear model
Comparison: HDLp-value: 0.37995% CI: [-0.71, 1.86]mixed-effect linear model
Comparison: Triglyceridesp-value: <0.00195% CI: [-28.72, -7.81]Mixed-effect linear model
Secondary
Change From Baseline in Lipid Parameters at Month 4
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.
Time frame: Baseline, Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Caduet | Change From Baseline in Lipid Parameters at Month 4 | HDL | -0.2060 mg/dL |
| Caduet | Change From Baseline in Lipid Parameters at Month 4 | TC | -42.7542 mg/dL |
| Caduet | Change From Baseline in Lipid Parameters at Month 4 | Triglycerides | -20.5645 mg/dL |
| Caduet | Change From Baseline in Lipid Parameters at Month 4 | LDL | -38.2765 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 4 | Triglycerides | 3.0828 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 4 | TC | -3.8144 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 4 | HDL | -1.1978 mg/dL |
| Usual Care | Change From Baseline in Lipid Parameters at Month 4 | LDL | -2.9628 mg/dL |
Comparison: TCp-value: <0.00195% CI: [-43.71, -34.17]Mixed-effect linear model
Comparison: LDLp-value: <0.00195% CI: [-39.64, -30.99]Mixed-effect linear model
Comparison: HDLp-value: 0.08795% CI: [-0.14, 2.13]mixed-effect linear model
Comparison: Triglyceridesp-value: <0.00195% CI: [-32.6, -14.7]Mixed-effect linear model
Secondary
Change From Baseline in SBP at Month 12
Time frame: Baseline, Month 12
Population: FAS, number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Caduet | Change From Baseline in SBP at Month 12 | -18.2409 mmHg |
| Usual Care | Change From Baseline in SBP at Month 12 | -12.4903 mmHg |
p-value: <0.00195% CI: [-8, -3.5]Mixed-effect linear model
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) at Month 4
Time frame: Baseline, Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Caduet | Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 | -15.3088 mmHG |
| Usual Care | Change From Baseline in Systolic Blood Pressure (SBP) at Month 4 | -12.1619 mmHG |
p-value: <0.00795% CI: [-5.42, -0.88]Mixed-effect linear model
Secondary
European SCORE 10-year Risk of Fatal CVD at Month 4
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).
Time frame: Baseline, Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caduet | European SCORE 10-year Risk of Fatal CVD at Month 4 | 3.1 percent risk | Standard Deviation 3.13 |
| Usual Care | European SCORE 10-year Risk of Fatal CVD at Month 4 | 3.7 percent risk | Standard Deviation 3.69 |
p-value: <0.00195% CI: [-1.16, -0.59]Mixed-effect linear model
Secondary
European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12
European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).
Time frame: Baseline, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caduet | European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 | 3.0 percent risk | Standard Deviation 2.89 |
| Usual Care | European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12 | 3.7 percent risk | Standard Deviation 3.69 |
p-value: <0.00195% CI: [-1.23, -0.72]Mixed-effect linear model
Secondary
Framingham 10-year Risk of Stroke at Month 12
Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Time frame: Baseline, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caduet | Framingham 10-year Risk of Stroke at Month 12 | 3.7 percent risk | Standard Deviation 2.25 |
| Usual Care | Framingham 10-year Risk of Stroke at Month 12 | 4.9 percent risk | Standard Deviation 2.87 |
p-value: <0.00195% CI: [-1.56, -1.15]Mixed-effect linear model
Secondary
Framingham 10-year Risk of Stroke at Month 4
Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific calibration factor for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).
Time frame: Baseline, Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caduet | Framingham 10-year Risk of Stroke at Month 4 | 3.7 percent risk | Standard Deviation 2.21 |
| Usual Care | Framingham 10-year Risk of Stroke at Month 4 | 4.9 percent risk | Standard Deviation 2.81 |
p-value: <0.00195% CI: [-1.57, -1.14]Mixed-effect linear model
Secondary
Framingham 10-year Risk of Total CHD at Month 4
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).
Time frame: Baseline, Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caduet | Framingham 10-year Risk of Total CHD at Month 4 | 12.5 percent risk | Standard Deviation 7.96 |
| Usual Care | Framingham 10-year Risk of Total CHD at Month 4 | 16.3 percent risk | Standard Deviation 10.8 |
p-value: <0.00195% CI: [-5.58, -3.93]Mixed-effect linear model
Secondary
Mean Lipid Parameters at Month 12
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Time frame: Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Mean Lipid Parameters at Month 12 | TC | 163.3 mg/dL | Standard Deviation 38.42 |
| Caduet | Mean Lipid Parameters at Month 12 | HDL | 47.3 mg/dL | Standard Deviation 13.48 |
| Caduet | Mean Lipid Parameters at Month 12 | LDL | 87.1 mg/dL | Standard Deviation 32.4 |
| Caduet | Mean Lipid Parameters at Month 12 | Triglycerides | 151.5 mg/dL | Standard Deviation 98.61 |
| Usual Care | Mean Lipid Parameters at Month 12 | Triglycerides | 166.4 mg/dL | Standard Deviation 98.53 |
| Usual Care | Mean Lipid Parameters at Month 12 | TC | 196.6 mg/dL | Standard Deviation 36.36 |
| Usual Care | Mean Lipid Parameters at Month 12 | LDL | 117.3 mg/dL | Standard Deviation 31.57 |
| Usual Care | Mean Lipid Parameters at Month 12 | HDL | 47.1 mg/dL | Standard Deviation 13.61 |
Comparison: TCp-value: <0.00195% CI: [-37.57, -28.56]Mixed-effect linear model
Comparison: LDLp-value: <0.00195% CI: [-33.7, -25.95]Mixed-effect linear model
Comparison: HDLp-value: 0.37995% CI: [-0.71, 1.86]Mixed-effect linear model
Comparison: Triglyceridesp-value: <0.00195% CI: [-28.72, -7.81]Mixed-effect linear model
Secondary
Mean Lipid Parameters at Month 4
Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.
Time frame: Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Mean Lipid Parameters at Month 4 | TC | 156.0 mg/dL | Standard Deviation 34.14 |
| Caduet | Mean Lipid Parameters at Month 4 | LDL | 80.9 mg/dL | Standard Deviation 28.47 |
| Caduet | Mean Lipid Parameters at Month 4 | HDL | 47.6 mg/dL | Standard Deviation 13.93 |
| Caduet | Mean Lipid Parameters at Month 4 | Triglycerides | 143.5 mg/dL | Standard Deviation 83.26 |
| Usual Care | Mean Lipid Parameters at Month 4 | Triglycerides | 164.8 mg/dL | Standard Deviation 95.74 |
| Usual Care | Mean Lipid Parameters at Month 4 | TC | 195.2 mg/dL | Standard Deviation 37.03 |
| Usual Care | Mean Lipid Parameters at Month 4 | HDL | 46.8 mg/dL | Standard Deviation 13.49 |
| Usual Care | Mean Lipid Parameters at Month 4 | LDL | 116.4 mg/dL | Standard Deviation 32.47 |
Comparison: TCp-value: <0.00195% CI: [-43.71, -34.17]Mixed-effect linear model
Comparison: LDLp-value: <0.00195% CI: [-39.64, -30.99]Mixed-effect linear model
Comparison: HDLp-value: 0.08795% CI: [-0.14, 2.13]Mixed-effect linear model
Comparison: Triglyceridesp-value: <0.00195% CI: [-32.6, -14.7]Mixed-effects linear model
Secondary
Mean Systolic and Diastolic Blood Pressure at Month 12
Time frame: Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing to data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Mean Systolic and Diastolic Blood Pressure at Month 12 | Systolic | 130.6 mmHg | Standard Deviation 13.84 |
| Caduet | Mean Systolic and Diastolic Blood Pressure at Month 12 | Diastolic | 79.2 mmHg | Standard Deviation 8.39 |
| Usual Care | Mean Systolic and Diastolic Blood Pressure at Month 12 | Systolic | 134.3 mmHg | Standard Deviation 15.21 |
| Usual Care | Mean Systolic and Diastolic Blood Pressure at Month 12 | Diastolic | 81.1 mmHg | Standard Deviation 9.27 |
Secondary
Mean Systolic and Diastolic Blood Pressure at Month 4
Time frame: Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caduet | Mean Systolic and Diastolic Blood Pressure at Month 4 | Systolic | 133.5 mmHg | Standard Deviation 14.32 |
| Caduet | Mean Systolic and Diastolic Blood Pressure at Month 4 | Diastolic | 80.7 mmHg | Standard Deviation 8.74 |
| Usual Care | Mean Systolic and Diastolic Blood Pressure at Month 4 | Systolic | 134.5 mmHg | Standard Deviation 14.96 |
| Usual Care | Mean Systolic and Diastolic Blood Pressure at Month 4 | Diastolic | 81.1 mmHg | Standard Deviation 9.32 |
Secondary
Number of Participants With Increase of Treatment Dosages After 4 Months.
Treatments indicative of prescribed medications other than study provided Caduet.
Time frame: Month 4
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caduet | Number of Participants With Increase of Treatment Dosages After 4 Months. | increase in either medication | 4 Participants |
| Caduet | Number of Participants With Increase of Treatment Dosages After 4 Months. | Increased dose | 30 Participants |
| Caduet | Number of Participants With Increase of Treatment Dosages After 4 Months. | increased dose of anti-hypertensive medications | 30 Participants |
| Caduet | Number of Participants With Increase of Treatment Dosages After 4 Months. | increased dose of lipid lowering medications | 0 Participants |
| Caduet | Number of Participants With Increase of Treatment Dosages After 4 Months. | increase in both medications | 0 Participants |
| Usual Care | Number of Participants With Increase of Treatment Dosages After 4 Months. | increase in both medications | 0 Participants |
| Usual Care | Number of Participants With Increase of Treatment Dosages After 4 Months. | increased dose of lipid lowering medications | 2 Participants |
| Usual Care | Number of Participants With Increase of Treatment Dosages After 4 Months. | Increased dose | 90 Participants |
| Usual Care | Number of Participants With Increase of Treatment Dosages After 4 Months. | increase in either medication | 45 Participants |
| Usual Care | Number of Participants With Increase of Treatment Dosages After 4 Months. | increased dose of anti-hypertensive medications | 88 Participants |
Secondary
Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months
Treatments indicative of prescribed medications other than study provided Caduet.
Time frame: Month 4, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: anti-hypertensive and/or lipid lowering | 648 participants |
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: anti-hypertensive | 647 participants |
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: lipid lowering | 45 participants |
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: anti-hypertensive and lipid lowering | 44 participants |
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: anti-hypertensive and/or lipid lowering | 655 participants |
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: anti-hypertensive | 654 participants |
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: lipid lowering | 46 participants |
| Caduet | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: anti-hypertensive and lipid lowering | 45 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: anti-hypertensive and lipid lowering | 204 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: anti-hypertensive and/or lipid lowering | 642 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: anti-hypertensive and/or lipid lowering | 642 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: anti-hypertensive | 637 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: lipid lowering | 208 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: lipid lowering | 202 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 12: anti-hypertensive | 638 participants |
| Usual Care | Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months | Month 4: anti-hypertensive and lipid lowering | 197 participants |
Secondary
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months
Goals set at \<140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and \<140/90 mm Hg or \<130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.
Time frame: Month 4, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | JNC Month 4 | 65.2 percentage of participants |
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | JNC Month 12 | 76.1 percentage of participants |
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | ESC Month 4 | 48.6 percentage of participants |
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | ESC Month 12 | 58.2 percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | ESC Month 12 | 47.5 percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | JNC Month 4 | 62.6 percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | ESC Month 4 | 46.0 percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months | JNC Month 12 | 60.6 percentage of participants |
Secondary
Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months
Goal set at \<100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at \<80 mg/dL according to the European (EU) Society of Cardiology guidelines.
Time frame: Month 4, Month 12
Population: FAS. Number of participants analyzed refers to number of participants contributing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | US Month 4 | 77.3 Percentage of participants |
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | US Month 12 | 71.9 Percentage of participants |
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | EU Month 4 | 52.4 Percentage of participants |
| Caduet | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | EU Month 12 | 46.7 Percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | EU Month 12 | 11.5 Percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | US Month 4 | 28.2 Percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | EU Month 4 | 13.3 Percentage of participants |
| Usual Care | Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months | US Month 12 | 28.8 Percentage of participants |