Hypercholesterolemia, Metabolic Syndrome
Conditions
Brief summary
A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.
Interventions
Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.
Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
DRUGComparator: Placebo (unspecified)
Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets. ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets. Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category
Exclusion criteria
* A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study * Patient is likely to be greater than 20% noncompliant in taking study medications * Patients with chronic medical conditions * Patients with unstable doses of medications * Pregnant or lactating women, women intending to become pregnant * Patient is currently receiving prescription therapy with statins or other lipid-altering medications * Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | Baseline and 6 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 | Baseline and 6 weeks |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) | Baseline and 6 Weeks |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) | Baseline and 6 Weeks |
| Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 | Baseline and 6 Weeks |
| Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 | Baseline and 6 Weeks |
Participant flow
Recruitment details
Phase III First Patient In 06-Feb-2007:; Last Patient Last Visit 16-Jul-2008 110 centers worldwide (International, 12 countries) Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease.
Pre-assignment details
Patients were randomized to 1 of 5 treatment groups: ezetimibe/simvastatin combination tablet or atorvastatin alone for 6 weeks stratified according to their baseline risk category stratum (high risk patients with atherosclerotic vascular disease or high risk patients without atherosclerotic vascular disease and moderately high risk patients).
Participants by arm
| Arm | Count |
|---|---|
| Atorva 10 mg Atorvastatin 10 mg once daily for 6 weeks | 229 |
| EZ/Simva 10 mg/20 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg | 229 |
| Atorva 20mg Atorvastatin 20 mg once daily for 6 weeks | 229 |
| EZ/Simva 10 mg/40 mg Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg | 228 |
| Atorva 40 mg Atorvastatin 40 mg once daily for 6 weeks | 228 |
| Total | 1,143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 4 | 2 | 6 |
| Overall Study | Lack of Eligibility | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 1 | 2 | 3 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 3 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Atorva 10 mg | EZ/Simva 10 mg/20 mg | Atorva 20mg | EZ/Simva 10 mg/40 mg | Atorva 40 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 59.7 years | 59.7 years | 58.2 years | 59.5 years | 58.4 years | 59.1 years |
| Race/Ethnicity, Customized Asian | 17 participants | 15 participants | 15 participants | 18 participants | 21 participants | 86 participants |
| Race/Ethnicity, Customized Black | 13 participants | 18 participants | 18 participants | 12 participants | 14 participants | 75 participants |
| Race/Ethnicity, Customized Other | 27 participants | 27 participants | 19 participants | 27 participants | 26 participants | 126 participants |
| Race/Ethnicity, Customized White | 172 participants | 169 participants | 177 participants | 171 participants | 167 participants | 856 participants |
| Sex: Female, Male Female | 97 Participants | 87 Participants | 106 Participants | 104 Participants | 104 Participants | 498 Participants |
| Sex: Female, Male Male | 132 Participants | 142 Participants | 123 Participants | 124 Participants | 124 Participants | 645 Participants |
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 | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / — | 14 / — | 22 / — | 13 / — | 13 / — |
| serious Total, serious adverse events | 4 / — | 0 / — | 1 / — | 1 / — | 4 / — |
Outcome results
Primary
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | -36.5 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | -49.6 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | -39.4 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | -53.9 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6 | -46.0 Percent Change |
p-value: <0.00195% CI: [-16.5, -9.8]ANOVA
p-value: <0.00195% CI: [-13.6, -6.9]ANOVA
p-value: <0.00195% CI: [-11.3, -4.6]ANOVA
Secondary
Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 | 0.8 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 | 3.2 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 | 1.0 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 | 3.0 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6 | 1.4 Percent Change |
p-value: 0.04295% CI: [0.1, 4.8]ANOVA
p-value: <0.00195% CI: [-0.2, 4.5]ANOVA
p-value: <0.00195% CI: [-7, 4]ANOVA
Secondary
Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 | -27.9 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 | -37.2 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 | -31.9 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 | -41.1 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6 | -35.8 Percent Change |
p-value: <0.00195% CI: [-12.1, -6.6]ANOVA
p-value: <0.00195% CI: [-8.1, -2.6]ANOVA
p-value: <0.00195% CI: [-8, -2.5]ANOVA
Secondary
Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6
Time frame: Baseline and 6 weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 | -27.4 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 | -38.4 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 | -32.0 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 | -41.9 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6 | -36.2 Percent Change |
p-value: <0.00195% CI: [-9.4, -3.3]ANOVA
p-value: <0.00195% CI: [-8.7, -2.7]ANOVA
p-value: <0.00195% CI: [-14, -8]ANOVA
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | 3.4 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | 6.8 Percent Change |
| Atorva 20mg | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | 5.6 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | 8.8 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | 4.9 Percent Change |
p-value: 0.01395% CI: [0.7, 6]ANOVA
p-value: 0.37895% CI: [-1.5, 3.8]ANOVA
p-value: 0.00395% CI: [1.3, 6.6]ANOVA
Secondary
Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 | -16.8 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 | -17.2 Percent Change |
| Atorva 20mg | Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 | -22.4 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 | -27.6 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6 | -30.0 Percent Change |
p-value: 0.4295% CI: [-11, 5]Non-parametric ANOVA
p-value: 0.55595% CI: [-9.5, 7.2]Non-parametric ANOVA
p-value: 0.4195% CI: [-5.1, 9.6]Non-parametric ANOVA
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | -37.8 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | -51.8 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | -42.1 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | -56.6 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6 | -48.2 Percent Change |
p-value: <0.00195% CI: [-17.6, -10.5]ANOVA
p-value: <0.00195% CI: [-13.2, -6.1]ANOVA
p-value: <0.00195% CI: [-12, -4.9]ANOVA
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) | -37.1 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) | -48.7 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) | -36.9 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) | -56.1 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD) | -45.8 Percent Change |
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) | -36.3 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) | -50.1 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) | -40.3 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) | -53.2 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD) | -46.1 Percent Change |
Secondary
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 | -34.7 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 | -46.2 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 | -39.2 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 | -51.2 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6 | -43.5 Percent Change |
p-value: <0.00195% CI: [-15, -8.1]ANOVA
p-value: <0.00195% CI: [-10.4, -3.6]ANOVA
p-value: <0.00195% CI: [-11.2, -4.3]ANOVA
Secondary
Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | -33.5 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | -43.8 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | -36.5 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | -48.3 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | -41.4 Percent Change |
p-value: <0.00195% CI: [-13.3, -7.3]ANOVA
p-value: <0.00195% CI: [-10.2, -4.3]ANOVA
p-value: <0.00195% CI: [-9.9, -3.9]ANOVA
Secondary
Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | -28.1 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | -36.9 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | -31.5 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | -41.2 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6 | -35.3 Percent Change |
p-value: <0.00195% CI: [-11.6, -6]ANOVA
p-value: <0.00195% CI: [-8.2, -2.5]ANOVA
p-value: <0.00195% CI: [-8.7, -3.1]ANOVA
Secondary
Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | -26.5 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | -33.7 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | -28.3 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | -37.3 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6 | -32.8 Percent Change |
p-value: <0.00195% CI: [-9.6, -4.8]ANOVA
p-value: <0.00195% CI: [-7.8, -2.9]ANOVA
p-value: <0.00195% CI: [-6.8, -2]ANOVA
Secondary
Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 | -21.7 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 | -23.3 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 | -27.5 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 | -29.5 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6 | -30.0 Percent Change |
p-value: 0.6995% CI: [-5.4, 3.3]Non-parametric ANOVA
p-value: 0.295% CI: [-1.6, 7.1]Non-parametric ANOVA
p-value: 0.4895% CI: [-4.7, 3.9]Non-parametric ANOVA
Secondary
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6
Time frame: Baseline and 6 Weeks
Population: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Atorva 10 mg | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | -17.7 Percent Change |
| EZ/Simva 10 mg/20 mg | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | -18.3 Percent Change |
| Atorva 20mg | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | -21.6 Percent Change |
| EZ/Simva 10 mg/40 mg | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | -23.4 Percent Change |
| Atorva 40 mg | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6 | -22.7 Percent Change |
p-value: 0.80995% CI: [-5.7, 4.5]ANOVA
p-value: 0.21795% CI: [-1.9, 8.4]ANOVA
p-value: 0.79695% CI: [-5.8, 4.4]ANOVA