Hypercholesterolemia
Conditions
Brief summary
A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.
Interventions
ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
DRUGatorvastatin
Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
Placebo (unspecified) daily for 12 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is age 65 or older * Patient is willing to maintain cholesterol lowering diet * Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category
Exclusion criteria
* A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study * Patient is unlikely to be compliant in taking study medication * Patient with chronic or unstable medical condition * Patient is taking unstable doses of medication * Patient drinks more than 2 alcoholic drinks per day * Patient has elevations in certain laboratory values (CK, AST, ALT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in LDL-C at Week 6 | Baseline and Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | Week 12 |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | Week 6 |
| Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | Week 12 |
| Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | Week 6 |
Other
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Triglycerides (TG) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Triglycerides (TG) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | Baseline and Week 6 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseine and Week 12 |
| Percent Change From Baseline in Total Cholesterol (TC) at Week 6 | Baseline and Week 6 |
Participant flow
Recruitment details
Phase III First Patient In: 28-Feb-2007; Last Patient Last Visit: 01-Oct-2008 143 centers worldwide (United States, Canada, Poland, Romania, Ukraine and Russia)
Pre-assignment details
Patients were stratified based on baseline LDL-C levels and presence or absence of atherosclerotic vascular disease to achieve balance across treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Atorva 10 mg + EZ \[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks | 526 |
| Atorva 20 mg / Atorva 40 mg Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks | 527 |
| Total | 1,053 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 9 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 7 |
Baseline characteristics
| Characteristic | Atorva 10 mg + EZ | Atorva 20 mg / Atorva 40 mg | Total |
|---|---|---|---|
| Age, Continuous | 71.2 years | 71.2 years | 71.2 years |
| Apo lipoprotein A-I (Apo A-I) | 164.3 mg/dL STANDARD_DEVIATION 28.7 | 164.4 mg/dL STANDARD_DEVIATION 26.8 | 164.4 mg/dL STANDARD_DEVIATION 27.7 |
| Apo lipoprotein B (Apo B) | 103.6 mg/dL STANDARD_DEVIATION 22.8 | 101.8 mg/dL STANDARD_DEVIATION 21.4 | 102.7 mg/dL STANDARD_DEVIATION 22.1 |
| Apo lipoprotein B (Apo B):Apo lipoprotein A-I (Apo A-I) Ratio | 0.6 Ratio STANDARD_DEVIATION 0.2 | 0.6 Ratio STANDARD_DEVIATION 0.2 | 0.6 Ratio STANDARD_DEVIATION 0.2 |
| BMI [Body Mass Index (<30, ≥30 kg/m2)] <30 kg/m2 | 359 Participants | 362 Participants | 721 Participants |
| BMI [Body Mass Index (<30, ≥30 kg/m2)] ≥30 kg/m2 | 165 Participants | 165 Participants | 330 Participants |
| BMI [Body Mass Index (<30, ≥30 kg/m2)] Missing | 2 Participants | 0 Participants | 2 Participants |
| High Density Lipoprotein Cholesterol (HDL-C) | 54.9 mg/dL STANDARD_DEVIATION 13.6 | 54.5 mg/dL STANDARD_DEVIATION 12.3 | 54.7 mg/dL STANDARD_DEVIATION 13 |
| Highly selective C-reactive protein (hs-CRP) | 1.8 mg/L STANDARD_DEVIATION 2.7 | 1.9 mg/L STANDARD_DEVIATION 2.3 | 1.9 mg/L STANDARD_DEVIATION 2.5 |
| Low Density Lipoprotein Cholesterol (LDL-C) | 102.9 mg/dL STANDARD_DEVIATION 27.7 | 101.8 mg/dL STANDARD_DEVIATION 20.7 | 102.3 mg/dL STANDARD_DEVIATION 24.4 |
| Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio | 2.0 Ratio STANDARD_DEVIATION 0.7 | 2.0 Ratio STANDARD_DEVIATION 0.6 | 2.0 Ratio STANDARD_DEVIATION 0.7 |
| Non-High Density Lipoprotein Cholesterol (Non-HDL-C) | 128.2 mg/dL STANDARD_DEVIATION 30.6 | 127.2 mg/dL STANDARD_DEVIATION 25.2 | 127.7 mg/dL STANDARD_DEVIATION 28.1 |
| Non-High Density Lipoprotein Cholesterol (Non-HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ra | 2.5 Ratio STANDARD_DEVIATION 0.9 | 2.5 Ratio STANDARD_DEVIATION 0.8 | 2.5 Ratio STANDARD_DEVIATION 0.9 |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 21 Participants | 17 Participants | 38 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 503 Participants | 505 Participants | 1008 Participants |
| Region of Enrollment Europe | 337 Participants | 330 Participants | 667 Participants |
| Region of Enrollment North America | 189 Participants | 197 Participants | 386 Participants |
| Sex: Female, Male Female | 277 Participants | 286 Participants | 563 Participants |
| Sex: Female, Male Male | 249 Participants | 241 Participants | 490 Participants |
| Total Cholesterol | 183.1 mg/dL STANDARD_DEVIATION 31.8 | 181.8 mg/dL STANDARD_DEVIATION 26.1 | 182.4 mg/dL STANDARD_DEVIATION 29.1 |
| Total Cholesterol (TC):High Density Lipoprotein-C (HDL-C) Ratio | 3.5 Ratio STANDARD_DEVIATION 0.9 | 3.5 Ratio STANDARD_DEVIATION 0.8 | 3.5 Ratio STANDARD_DEVIATION 0.9 |
| Triglycerides (TG) | 112.8 mg/dL STANDARD_DEVIATION 55.3 | 116.5 mg/dL STANDARD_DEVIATION 60 | 114.0 mg/dL STANDARD_DEVIATION 56.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / — | 54 / — |
| serious Total, serious adverse events | 15 / — | 14 / — |
Outcome results
Primary
Percent Change From Baseline in LDL-C at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in LDL-C at Week 6 | -26.7 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in LDL-C at Week 6 | -12.8 Percent Change |
p-value: <0.00195% CI: [-16, -11.7]ANCOVA
Secondary
Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6
Time frame: Week 6
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Atorva 10 mg + EZ | Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | <100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD) | 274 Participants |
| Atorva 10 mg + EZ | Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | >100 mg/dL (w/o AVD) and ≥70 mg/dL (w/AVD) | 241 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | <100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD) | 127 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6 | >100 mg/dL (w/o AVD) and ≥70 mg/dL (w/AVD) | 388 Participants |
p-value: <0.00195% CI: [3.98, 7.55]Regression, Logistic
Secondary
Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12
Time frame: Week 12
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Atorva 10 mg + EZ | Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | <100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD) | 255 Participants |
| Atorva 10 mg + EZ | Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | ≥100 mg/dL (w/o AVD) and ≥70 mg/dL (w/ AVD) | 261 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | <100 mg/dL (w/o AVD) and <70 mg/dL (w/ AVD) | 200 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12 | ≥100 mg/dL (w/o AVD) and ≥70 mg/dL (w/ AVD) | 309 Participants |
p-value: <0.00195% CI: [1.32, 2.31]Regression, Logistic
Secondary
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12
Time frame: Week 12
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Atorva 10 mg + EZ | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | <70 mg/dL | 225 Participants |
| Atorva 10 mg + EZ | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | ≥70 mg/dL | 291 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | <70 mg/dL | 164 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12 | ≥70 mg/dL | 345 Participants |
p-value: <0.00195% CI: [1.4, 2.5]Regression, Logistic
Secondary
Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
Time frame: Week 6
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Atorva 10 mg + EZ | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | <70 mg/dL | 244 Participants |
| Atorva 10 mg + EZ | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | ≥70 mg/dL | 271 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | <70 mg/dL | 92 Participants |
| Atorva 20 mg / Atorva 40 mg | Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 | ≥70 mg/dL | 423 Participants |
p-value: <0.00195% CI: [4.52, 8.84]Regression, Logistic
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -22.5 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -17.9 Percent Change |
p-value: <0.00195% CI: [-7.4, -1.8]ANCOVA
Other Pre-specified
Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12 | 0.7 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12 | -2.0 Percent Change |
p-value: <0.00195% CI: [1.1, 4.2]ANCOVA
Other Pre-specified
Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6 | -1.1 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6 | -1.7 Percent Change |
p-value: 0.40195% CI: [-0.9, 2.1]ANCOVA
Other Pre-specified
Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12 | -13.5 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12 | -8.2 Percent Change |
p-value: <0.00195% CI: [-7.7, -2.9]ANCOVA
Other Pre-specified
Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6 | -14.8 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6 | -5.2 Percent Change |
p-value: <0.00195% CI: [-11.6, -7.5]ANCOVA
Other Pre-specified
Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12 | -14.0 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12 | -10.8 Percent Change |
p-value: <0.00195% CI: [-5.5, -0.9]ANCOVA
Other Pre-specified
Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6 | -16.8 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6 | -7.7 Percent Change |
p-value: <0.00195% CI: [-11, -7.3]ANCOVA
Other Pre-specified
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | 2.4 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | -0.8 Percent Change |
p-value: <0.00195% CI: [1.5, 4.8]ANCOVA
Other Pre-specified
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | 2.5 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6 | 0.7 Percent Change |
p-value: <0.00195% CI: [0.3, 3.5]ANCOVA
Other Pre-specified
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | -22.9 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | -16.0 Percent Change |
p-value: <0.00195% CI: [-10.1, -3.7]ANCOVA
Other Pre-specified
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | -27.2 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | -12.6 Percent Change |
p-value: <0.00195% CI: [-17, -12.2]ANCOVA
Other Pre-specified
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time frame: Baseine and Week 12
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 + EZ | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -20.0 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -15.8 Percent Change |
p-value: <0.00195% CI: [-6.8, -1.7]ANCOVA
Other Pre-specified
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | -23.5 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 | -11.2 Percent Change |
p-value: <0.00195% CI: [-14.2, -10.3]ANCOVA
Other Pre-specified
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | -20.4 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | -13.8 Percent Change |
p-value: <0.00195% CI: [-9.8, -3.6]ANCOVA
Other Pre-specified
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | -24.0 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | -11.1 Percent Change |
p-value: <0.00195% CI: [-15.3, -10.5]ANCOVA
Other Pre-specified
Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12 | -21.7 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12 | -14.6 Percent Change |
p-value: 0.0995% CI: [-15.6, 1.6]Longitudinal Data Analysis (LDA)
Other Pre-specified
Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6 | -13.5 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6 | -10.7 Percent Change |
p-value: 0.53495% CI: [-11.9, 6.4]Longitudinal Data Analysis (LDA)
Other Pre-specified
Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | -13.6 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Total Cholesterol (TC) at Week 12 | -11.6 Percent Change |
p-value: <0.00195% CI: [-3.8, -0.2]ANCOVA
Other Pre-specified
Percent Change From Baseline in Total Cholesterol (TC) at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Total Cholesterol (TC) at Week 6 | -15.9 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Total Cholesterol (TC) at Week 6 | -8.0 Percent Change |
p-value: <0.00195% CI: [-9.4, -6.5]ANCOVA
Other Pre-specified
Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | -14.4 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12 | -9.8 Percent Change |
p-value: <0.00195% CI: [-6.8, -2.4]ANCOVA
Other Pre-specified
Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | -16.9 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 | -7.9 Percent Change |
p-value: <0.00195% CI: [-10.7, -7.3]ANCOVA
Other Pre-specified
Percent Change From Baseline in Triglycerides (TG) at Week 12
Time frame: Baseline and Week 12
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 + EZ | Percent Change From Baseline in Triglycerides (TG) at Week 12 | -11.8 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Triglycerides (TG) at Week 12 | -8.5 Percent Change |
p-value: <0.00195% CI: [-5.2, 1]Nonparametric ANCOVA
Other Pre-specified
Percent Change From Baseline in Triglycerides (TG) at Week 6
Time frame: Baseline and Week 6
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 + EZ | Percent Change From Baseline in Triglycerides (TG) at Week 6 | -12.9 Percent Change |
| Atorva 20 mg / Atorva 40 mg | Percent Change From Baseline in Triglycerides (TG) at Week 6 | -5.7 Percent Change |
p-value: <0.00195% CI: [-9, -3.4]Nonparametric ANCOVA