Hypercholesterolemia
Conditions
Keywords
Japanese, High cholesterol, Treatment of high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia, Statin intolerant
Brief summary
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin.
Detailed description
After screening participants who met all inclusion/exclusion criteria were randomized with an allocation ratio of 2:2:1:1 into 4 groups: evolocumab (AMG 145) 420 mg administered by subcutaneous injection monthly and placebo pill daily; evolocumab 140 mg administered by subcutaneous injection every two weeks and placebo pill by mouth daily; placebo 420 mg administered by subcutaneous injection monthly and ezetimibe 10 mg pill daily; placebo 140 mg administered subcutaneous injection every two weeks and ezetimibe 10 mg pill daily. Randomization was stratified by screening LDL-C level and baseline statin use. Participants on low or atypical statin dose therapy must have been on a stable dose for at least 4 weeks prior to screening and throughout the blinded portion of the study; the dose could not be adjusted during screening and for the duration of the study. After Week 12, ezetimibe was discontinued and participants moved to an open-label dose of evolocumab administered by subcutaneous injection either every two weeks or monthly and their standard of care.
Interventions
BIOLOGICALEvolocumab
Administered by subcutaneous injection
DRUGEzetimibe
Tablet for oral administration
Administered by subcutaneous injection
Tablet for oral administration
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 20 to ≤ 80 years of age * Japanese by self-identification * Not on a statin or on a low dose statin with stable dose for at least 4 weeks. * Subject not at LDL-C goal * History of statin intolerance to at least 2 statins * Lipid lowering therapy has been stable prior to screening for at least 4 weeks * Fasting triglycerides ≤ 400 mg/dL
Exclusion criteria
* New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Type 1 diabetes * Poorly controlled type 2 diabetes * Uncontrolled hypothyroidism or hyperthyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis. |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and week 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | Weeks 10 and 12 | Mean low density lipoprotein-cholesterol response was defined as LDL-C \< 70 mg/dL \[1.8 mol/L\]. |
| Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12 | Week 12 | — |
| Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in Total Cholesterol at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 | — |
| Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and week 12 | — |
| Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in Lipoprotein(a) at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in Triglycerides at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in HDL-C at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Percent Change From Baseline in VLDL-C at Week 12 | Baseline and week 12 | — |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | — |
| Change From Baseline in LDL-C at Week 12 | Baseline and week 12 | — |
Countries
Japan
Participant flow
Recruitment details
This study was conducted at 30 centers in Japan. Participants were enrolled from 27 February 2016 to 18 May 2017. The study consisted of a 12-week double-blind (DB) treatment period and a 9-month open-label extension (OLE) period.
Pre-assignment details
Participants were randomized 1:1:2:2 into 1 of 4 treatment groups for the 12-week, double-blind treatment period. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C) level (\< 180 mg/dL vs. ≥ 180 mg/dL) and baseline statin use (yes vs. no).
Participants by arm
| Arm | Count |
|---|---|
| Ezetimibe (Q2W) Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. | 10 |
| Ezetimibe (QM) Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. | 11 |
| Evolocumab Q2W Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. | 19 |
| Evolocumab QM Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks. | 21 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-blind Treatment Period | Subject Request | 1 | 0 | 1 | 1 |
| Open-label Extension Period | Withdrawal by Subject | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Ezetimibe (QM) | Evolocumab Q2W | Ezetimibe (Q2W) | Evolocumab QM |
|---|---|---|---|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 10.6 | 58.7 years STANDARD_DEVIATION 12.5 | 65.1 years STANDARD_DEVIATION 10.5 | 65.2 years STANDARD_DEVIATION 10.8 | 66.4 years STANDARD_DEVIATION 9.3 |
| ApolipoproteinB/Apolipoprotein A1 Ratio | 0.9 ratio STANDARD_DEVIATION 0.3 | 0.8 ratio STANDARD_DEVIATION 0.2 | 1.0 ratio STANDARD_DEVIATION 0.4 | 0.8 ratio STANDARD_DEVIATION 0.2 | 0.9 ratio STANDARD_DEVIATION 0.2 |
| Apolipoprotein B Concentration | 135.1 mg/dL STANDARD_DEVIATION 27.9 | 121.9 mg/dL STANDARD_DEVIATION 29.3 | 140.4 mg/dL STANDARD_DEVIATION 31.7 | 132.1 mg/dL STANDARD_DEVIATION 19.4 | 138.7 mg/dL STANDARD_DEVIATION 26.2 |
| High-density Lipoprotein Cholesterol (HDL-C) Concentration | 60.8 mg/dL STANDARD_DEVIATION 18.6 | 64.1 mg/dL STANDARD_DEVIATION 16.1 | 54.3 mg/dL STANDARD_DEVIATION 18.2 | 62.5 mg/dL STANDARD_DEVIATION 15.6 | 64.1 mg/dL STANDARD_DEVIATION 20.9 |
| Intolerance to Statins Four or more statins | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Intolerance to Statins One statin | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Intolerance to Statins Three statins | 10 Participants | 1 Participants | 3 Participants | 2 Participants | 4 Participants |
| Intolerance to Statins Two statins | 45 Participants | 10 Participants | 14 Participants | 7 Participants | 14 Participants |
| LDL-C Concentration | 189.0 mg/dL STANDARD_DEVIATION 53.9 | 182.7 mg/dL STANDARD_DEVIATION 72.2 | 198.1 mg/dL STANDARD_DEVIATION 64.1 | 181.0 mg/dL STANDARD_DEVIATION 34.7 | 188.0 mg/dL STANDARD_DEVIATION 41.6 |
| Lipoprotein(a) Concentration | 61.7 nmol/L STANDARD_DEVIATION 79.5 | 66.0 nmol/L STANDARD_DEVIATION 83.2 | 61.3 nmol/L STANDARD_DEVIATION 72.6 | 48.0 nmol/L STANDARD_DEVIATION 72.3 | 66.2 nmol/L STANDARD_DEVIATION 91 |
| Non-HDL-C Concentration | 219.8 mg/dL STANDARD_DEVIATION 53.7 | 211.1 mg/dL STANDARD_DEVIATION 71.2 | 227.7 mg/dL STANDARD_DEVIATION 63.3 | 217.5 mg/dL STANDARD_DEVIATION 37.3 | 218.2 mg/dL STANDARD_DEVIATION 42.2 |
| Race/Ethnicity, Customized Japanese | 61 Participants | 11 Participants | 19 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Female | 31 Participants | 5 Participants | 9 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 30 Participants | 6 Participants | 10 Participants | 5 Participants | 9 Participants |
| Stratification Factor: Baseline Statin Use No | 47 Participants | 8 Participants | 16 Participants | 7 Participants | 16 Participants |
| Stratification Factor: Baseline Statin Use Yes | 14 Participants | 3 Participants | 3 Participants | 3 Participants | 5 Participants |
| Stratification Factor: Screening LDL-C Level < 180 mg/dL [4.66 mmol/L] | 30 Participants | 6 Participants | 9 Participants | 5 Participants | 10 Participants |
| Stratification Factor: Screening LDL-C Level ≥ 180 mg/dL [4.66 mmol/L] | 31 Participants | 5 Participants | 10 Participants | 5 Participants | 11 Participants |
| Total Cholesterol Concentration | 280.5 mg/dL STANDARD_DEVIATION 57.3 | 275.2 mg/dL STANDARD_DEVIATION 79.7 | 282.0 mg/dL STANDARD_DEVIATION 63.9 | 280.0 mg/dL STANDARD_DEVIATION 34.4 | 282.3 mg/dL STANDARD_DEVIATION 49.6 |
| Total cholesterol/HDL-C ratio | 5.0 ratio STANDARD_DEVIATION 1.6 | 4.4 ratio STANDARD_DEVIATION 1.1 | 5.7 ratio STANDARD_DEVIATION 2 | 4.8 ratio STANDARD_DEVIATION 1.4 | 4.8 ratio STANDARD_DEVIATION 1.4 |
| Triglycerides Concentration | 153.8 mg/dL STANDARD_DEVIATION 73.7 | 142.3 mg/dL STANDARD_DEVIATION 80.1 | 148.0 mg/dL STANDARD_DEVIATION 59.8 | 183.1 mg/dL STANDARD_DEVIATION 111.1 | 151.0 mg/dL STANDARD_DEVIATION 61.3 |
| Very Low-density Lipoprotein Cholesterol (VLDL) Concentration | 30.7 mg/dL STANDARD_DEVIATION 14.7 | 28.4 mg/dL STANDARD_DEVIATION 16.1 | 29.6 mg/dL STANDARD_DEVIATION 12 | 36.5 mg/dL STANDARD_DEVIATION 21.9 | 30.2 mg/dL STANDARD_DEVIATION 12.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 | 0 / 19 | 0 / 21 | 0 / 59 |
| other Total, other adverse events | 4 / 10 | 8 / 11 | 11 / 19 | 12 / 21 | 44 / 58 |
| serious Total, serious adverse events | 1 / 10 | 1 / 11 | 0 / 19 | 0 / 21 | 4 / 58 |
Outcome results
Primary
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12
For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis.
Time frame: Baseline and Weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | -20.39 percent change | Standard Error 3.19 |
| Evolocumab | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 | -59.75 percent change | Standard Error 2.3 |
p-value: <0.000195% CI: [-47.23, -31.48]Repeated measures linear effects model
Primary
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -19.13 percent change | Standard Error 3.45 |
| Evolocumab | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -59.27 percent change | Standard Error 2.5 |
p-value: <0.000195% CI: [-48.68, -31.6]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -35.6 mg/dL | Standard Error 6.6 |
| Evolocumab | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -113.2 mg/dL | Standard Error 4.8 |
p-value: <0.000195% CI: [-93.9, -61.3]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Change From Baseline in LDL-C at Week 12 | -33.4 mg/dL | Standard Error 7 |
| Evolocumab | Change From Baseline in LDL-C at Week 12 | -112.7 mg/dL | Standard Error 5.1 |
p-value: <0.000195% CI: [-96.7, -62]Repeated measures linear effects model
Secondary
Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12
Time frame: Week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe | Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12 | 0.00 percentage of participants |
| Evolocumab | Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12 | 52.63 percentage of participants |
p-value: <0.000195% CI: [30.36, 67.52]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Mean low density lipoprotein-cholesterol response was defined as LDL-C \< 70 mg/dL \[1.8 mol/L\].
Time frame: Weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 0.00 percentage of participants |
| Evolocumab | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 56.41 percentage of participants |
p-value: <0.000195% CI: [34.1, 70.7]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12 | -15.39 percent change | Standard Error 2.67 |
| Evolocumab | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12 | -52.46 percent change | Standard Error 1.91 |
p-value: <0.000195% CI: [-43.65, -30.5]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -15.62 percent change | Standard Error 2.88 |
| Evolocumab | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -51.91 percent change | Standard Error 2.06 |
p-value: <0.000195% CI: [-43.39, -29.2]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -13.23 percent change | Standard Error 2.69 |
| Evolocumab | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -48.90 percent change | Standard Error 1.93 |
p-value: <0.000195% CI: [-42.3, -29.04]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Apolipoprotein B at Week 12 | -11.32 percent change | Standard Error 2.99 |
| Evolocumab | Percent Change From Baseline in Apolipoprotein B at Week 12 | -47.91 percent change | Standard Error 2.14 |
p-value: <0.000195% CI: [-43.98, -29.22]Repeated measures linear effects model
Secondary
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 3.10 percent change | Standard Error 2.5 |
| Evolocumab | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 11.06 percent change | Standard Error 1.8 |
p-value: 0.01295% CI: [1.78, 14.14]Repeated measures linear effects model
Secondary
Percent Change From Baseline in HDL-C at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in HDL-C at Week 12 | 6.45 percent change | Standard Error 2.59 |
| Evolocumab | Percent Change From Baseline in HDL-C at Week 12 | 12.04 percent change | Standard Error 1.88 |
p-value: 0.08695% CI: [-0.82, 12]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -5.89 percent change | Standard Error 4.34 |
| Evolocumab | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -37.02 percent change | Standard Error 3.11 |
p-value: <0.000195% CI: [-41.83, -20.43]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -5.21 percent change | Standard Error 5.02 |
| Evolocumab | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -36.41 percent change | Standard Error 3.59 |
p-value: <0.000195% CI: [-43.57, -18.84]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | -18.82 percent change | Standard Error 2.77 |
| Evolocumab | Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | -52.35 percent change | Standard Error 2.01 |
p-value: <0.000195% CI: [-40.38, -26.68]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Non-HDL-C at Week 12 | -18.28 percent change | Standard Error 3.03 |
| Evolocumab | Percent Change From Baseline in Non-HDL-C at Week 12 | -51.71 percent change | Standard Error 2.2 |
p-value: <0.000195% CI: [-40.94, -25.94]Repeated measures linear effects model
Secondary
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -15.73 percent change | Standard Error 2.69 |
| Evolocumab | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -44.34 percent change | Standard Error 1.94 |
p-value: <0.000195% CI: [-35.26, -21.97]Repeated measures linear effects model
Secondary
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -17.34 percent change | Standard Error 2.81 |
| Evolocumab | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -44.39 percent change | Standard Error 2.04 |
p-value: <0.000195% CI: [-34, -20.09]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 | -13.80 percent change | Standard Error 2.17 |
| Evolocumab | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 | -39.24 percent change | Standard Error 1.57 |
p-value: <0.000195% CI: [-30.8, -20.08]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Total Cholesterol at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Total Cholesterol at Week 12 | -12.69 percent change | Standard Error 2.34 |
| Evolocumab | Percent Change From Baseline in Total Cholesterol at Week 12 | -38.52 percent change | Standard Error 1.7 |
p-value: <0.000195% CI: [-31.63, -20.04]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -5.21 percent change | Standard Error 5.92 |
| Evolocumab | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -1.73 percent change | Standard Error 4.28 |
p-value: 0.6395% CI: [-11.15, 18.13]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in Triglycerides at Week 12 | -9.87 percent change | Standard Error 7.71 |
| Evolocumab | Percent Change From Baseline in Triglycerides at Week 12 | 1.92 percent change | Standard Error 5.6 |
p-value: 0.2295% CI: [-7.29, 30.87]Repeated measures linear effects model
Secondary
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 | -4.67 percent change | Standard Error 5.89 |
| Evolocumab | Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 | -5.34 percent change | Standard Error 4.25 |
p-value: 0.9395% CI: [-15.22, 13.87]Repeated measures linear effects model
Secondary
Percent Change From Baseline in VLDL-C at Week 12
Time frame: Baseline and week 12
Population: All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe | Percent Change From Baseline in VLDL-C at Week 12 | -9.06 percent change | Standard Error 8 |
| Evolocumab | Percent Change From Baseline in VLDL-C at Week 12 | -1.42 percent change | Standard Error 5.8 |
p-value: 0.4495% CI: [-12.15, 27.43]Repeated measures linear effects model