Hyperlipidemia
Conditions
Keywords
High cholesterol, Proprotein convertase subtilisin/kexin type 9 (PCSK9), Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Brief summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Interventions
BIOLOGICALEvolocumab
Administered by subcutaneous injection
DRUGEzetimibe
Administered orally once a day
Administered by subcutaneous injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 to ≤ 75 years of age * Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and \< 190 mg/dL * Framingham risk score of 10% or less * Fasting triglycerides \< 400 mg/dL
Exclusion criteria
* History of coronary heart disease * New York Heart Association (NYHA) II - IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 | LDL-C was measured using ultracentrifugation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 | LDL-C was measured using ultracentrifugation. |
| Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Baseline and Week 12 | — |
| Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 | — |
| Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and Week 12 | — |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | Baseline and Week 12 | — |
Countries
Australia, Belgium, Canada, Denmark, United States
Participant flow
Recruitment details
This study enrolled adults 18 - 75 years with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and \< 190 mg/dL, fasting triglycerides ≤ 400 mg/dL and a National Cholesterol Education Program Adult Treatment Panel III Framingham risk score of 10% or less. First patient enrolled 06 July 2011, last patient enrolled 25 November 2011.
Pre-assignment details
Participants were randomized with equal allocation into 1 of 9 treatment groups. Randomization was stratified on the basis of screening LDL-C concentration (\< 130 mg/dL \[3.4 mmol/L\] or ≥ 130 mg/dL).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Q2W Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | 45 |
| Placebo Q4W Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. | 45 |
| Ezetimibe Participants received 10 mg ezetimibe orally once a day for 12 weeks. | 45 |
| Evolocumab 70 mg Q2W Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | 45 |
| Evolocumab 105 mg Q2W Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | 46 |
| Evolocumab 140 mg Q2W Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | 45 |
| Evolocumab 280 mg Q4W Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | 45 |
| Evolocumab 350 mg Q4W Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | 45 |
| Evolocumab 420 mg Q4W Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | 45 |
| Total | 406 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Other | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo Q4W | Total | Evolocumab 420 mg Q4W | Evolocumab 350 mg Q4W | Evolocumab 280 mg Q4W | Evolocumab 140 mg Q2W | Placebo Q2W | Evolocumab 105 mg Q2W | Evolocumab 70 mg Q2W | Ezetimibe |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 12.6 | 50.6 years STANDARD_DEVIATION 11.8 | 50.1 years STANDARD_DEVIATION 12 | 50.9 years STANDARD_DEVIATION 13.1 | 49.3 years STANDARD_DEVIATION 10.3 | 52.8 years STANDARD_DEVIATION 11.6 | 52.5 years STANDARD_DEVIATION 9.8 | 48.3 years STANDARD_DEVIATION 11.8 | 50.9 years STANDARD_DEVIATION 12.9 | 50.0 years STANDARD_DEVIATION 12 |
| Apolipoprotein B/Apolipoprotein A-1 Ratio | 0.785 ratio STANDARD_DEVIATION 0.322 | 0.738 ratio STANDARD_DEVIATION 0.196 | 0.758 ratio STANDARD_DEVIATION 0.191 | 0.706 ratio STANDARD_DEVIATION 0.185 | 0.751 ratio STANDARD_DEVIATION 0.161 | 0.709 ratio STANDARD_DEVIATION 0.175 | 0.729 ratio STANDARD_DEVIATION 0.18 | 0.744 ratio STANDARD_DEVIATION 0.168 | 0.705 ratio STANDARD_DEVIATION 0.161 | 0.752 ratio STANDARD_DEVIATION 0.176 |
| Apolipoprotein B Concentration | 110.4 mg/dL STANDARD_DEVIATION 17.2 | 109.1 mg/dL STANDARD_DEVIATION 16.5 | 110.2 mg/dL STANDARD_DEVIATION 18.4 | 105.8 mg/dL STANDARD_DEVIATION 15.9 | 109.2 mg/dL STANDARD_DEVIATION 15.7 | 107.2 mg/dL STANDARD_DEVIATION 16.3 | 111.7 mg/dL STANDARD_DEVIATION 17.1 | 108.5 mg/dL STANDARD_DEVIATION 15.2 | 108.7 mg/dL STANDARD_DEVIATION 15.7 | 109.9 mg/dL STANDARD_DEVIATION 17.7 |
| LDL-C Concentration | 142.3 mg/dL STANDARD_DEVIATION 24.3 | 141.6 mg/dL STANDARD_DEVIATION 22.3 | 138.9 mg/dL STANDARD_DEVIATION 21.9 | 136.6 mg/dL STANDARD_DEVIATION 20.8 | 141.1 mg/dL STANDARD_DEVIATION 21.8 | 139.8 mg/dL STANDARD_DEVIATION 21.1 | 147.0 mg/dL STANDARD_DEVIATION 21 | 141.5 mg/dL STANDARD_DEVIATION 22.3 | 143.1 mg/dL STANDARD_DEVIATION 21.7 | 144.2 mg/dL STANDARD_DEVIATION 25.8 |
| Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration | 169.1 mg/dL STANDARD_DEVIATION 27.7 | 167.8 mg/dL STANDARD_DEVIATION 27.4 | 167.9 mg/dL STANDARD_DEVIATION 29.6 | 161.1 mg/dL STANDARD_DEVIATION 26.1 | 166.3 mg/dL STANDARD_DEVIATION 27.8 | 163.8 mg/dL STANDARD_DEVIATION 23.7 | 173.8 mg/dL STANDARD_DEVIATION 30.5 | 169.2 mg/dL STANDARD_DEVIATION 24.3 | 169.0 mg/dL STANDARD_DEVIATION 24.5 | 170.0 mg/dL STANDARD_DEVIATION 32 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 3 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 17 participants | 2 participants | 2 participants | 1 participants | 2 participants | 2 participants | 3 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 7 participants | 64 participants | 10 participants | 6 participants | 8 participants | 4 participants | 8 participants | 5 participants | 7 participants | 9 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 6 participants | 56 participants | 10 participants | 5 participants | 7 participants | 8 participants | 5 participants | 5 participants | 5 participants | 5 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized ot Hispanic or Latino | 39 participants | 350 participants | 35 participants | 40 participants | 38 participants | 37 participants | 40 participants | 41 participants | 40 participants | 40 participants |
| Race/Ethnicity, Customized White | 36 participants | 319 participants | 33 participants | 36 participants | 35 participants | 39 participants | 35 participants | 37 participants | 33 participants | 35 participants |
| Sex: Female, Male Female | 30 Participants | 267 Participants | 26 Participants | 33 Participants | 28 Participants | 36 Participants | 25 Participants | 33 Participants | 30 Participants | 26 Participants |
| Sex: Female, Male Male | 15 Participants | 139 Participants | 19 Participants | 12 Participants | 17 Participants | 9 Participants | 20 Participants | 13 Participants | 15 Participants | 19 Participants |
| Stratification Factor: LDL-C level < 130 mg/dL | 14 participants | 131 participants | 14 participants | 15 participants | 15 participants | 14 participants | 15 participants | 15 participants | 14 participants | 15 participants |
| Stratification Factor: LDL-C level ≥ 130 mg/dL | 31 participants | 275 participants | 31 participants | 30 participants | 30 participants | 31 participants | 30 participants | 31 participants | 31 participants | 30 participants |
| Total Cholesterol/HDL-C Ratio | 4.793 ratio STANDARD_DEVIATION 1.836 | 4.512 ratio STANDARD_DEVIATION 1.351 | 4.741 ratio STANDARD_DEVIATION 1.656 | 4.335 ratio STANDARD_DEVIATION 1.282 | 4.500 ratio STANDARD_DEVIATION 1.154 | 4.181 ratio STANDARD_DEVIATION 1.131 | 4.477 ratio STANDARD_DEVIATION 1.293 | 4.571 ratio STANDARD_DEVIATION 1.269 | 4.335 ratio STANDARD_DEVIATION 1.09 | 4.670 ratio STANDARD_DEVIATION 1.258 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 45 | 10 / 45 | 14 / 45 | 11 / 45 | 11 / 46 | 14 / 45 | 7 / 45 | 11 / 45 | 9 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 | 0 / 45 | 0 / 45 | 1 / 46 | 1 / 45 | 0 / 45 | 1 / 45 | 0 / 45 |
Outcome results
Primary
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation.
Time frame: Baseline and Week 12
Population: Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -3.71 percent change | Standard Error 2.66 |
| Placebo Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 4.54 percent change | Standard Error 2.64 |
| Ezetimibe | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -14.26 percent change | Standard Error 2.6 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -40.98 percent change | Standard Error 2.64 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -43.87 percent change | Standard Error 2.6 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -50.93 percent change | Standard Error 2.66 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -39.02 percent change | Standard Error 2.57 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -43.20 percent change | Standard Error 2.57 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -47.98 percent change | Standard Error 2.58 |
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-54.52, -39.93]ANCOVA
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-47.38, -32.95]ANCOVA
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-44.53, -30.02]ANCOVA
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-59.67, -45.38]ANCOVA
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-54.89, -40.6]ANCOVA
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-50.71, -36.42]ANCOVA
Secondary
Change From Baseline in LDL-C at Week 12
LDL-C was measured using ultracentrifugation.
Time frame: Baseline and Week 12
Population: Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Change From Baseline in LDL-C at Week 12 | -3.4 mg/dL | Standard Error 3.9 |
| Placebo Q4W | Change From Baseline in LDL-C at Week 12 | 7.3 mg/dL | Standard Error 3.7 |
| Ezetimibe | Change From Baseline in LDL-C at Week 12 | -19.2 mg/dL | Standard Error 3.6 |
| Evolocumab 70 mg Q2W | Change From Baseline in LDL-C at Week 12 | -55.7 mg/dL | Standard Error 3.7 |
| Evolocumab 105 mg Q2W | Change From Baseline in LDL-C at Week 12 | -66.0 mg/dL | Standard Error 3.7 |
| Evolocumab 140 mg Q2W | Change From Baseline in LDL-C at Week 12 | -69.3 mg/dL | Standard Error 3.6 |
| Evolocumab 280 mg Q4W | Change From Baseline in LDL-C at Week 12 | -53.5 mg/dL | Standard Error 3.6 |
| Evolocumab 350 mg Q4W | Change From Baseline in LDL-C at Week 12 | -56.7 mg/dL | Standard Error 3.6 |
| Evolocumab 420 mg Q4W | Change From Baseline in LDL-C at Week 12 | -65.0 mg/dL | Standard Error 3.6 |
p-value: <0.00195% CI: [-76.3, -55.6]ANCOVA
p-value: <0.00195% CI: [-73.2, -52.2]ANCOVA
p-value: <0.00195% CI: [-62.7, -41.9]ANCOVA
p-value: <0.00195% CI: [-82.2, -62.4]ANCOVA
p-value: <0.00195% CI: [-73.9, -54]ANCOVA
p-value: <0.00195% CI: [-70.7, -50.9]ANCOVA
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | 2.03 percent change | Standard Error 2.4 |
| Placebo Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | 0.14 percent change | Standard Error 2.46 |
| Ezetimibe | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -12.35 percent change | Standard Error 2.33 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -32.80 percent change | Standard Error 2.38 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -38.30 percent change | Standard Error 2.35 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -48.13 percent change | Standard Error 2.4 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -36.10 percent change | Standard Error 2.39 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -40.43 percent change | Standard Error 2.39 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -45.33 percent change | Standard Error 2.4 |
p-value: <0.00195% CI: [-56.75, -43.58]ANCOVA
p-value: <0.00195% CI: [-46.84, -33.82]ANCOVA
p-value: <0.00195% CI: [-41.38, -28.28]ANCOVA
p-value: <0.00195% CI: [-52.12, -38.82]ANCOVA
p-value: <0.00195% CI: [-47.22, -33.92]ANCOVA
p-value: <0.00195% CI: [-42.9, -29.6]ANCOVA
Secondary
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -0.33 percent change | Standard Error 2.28 |
| Placebo Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 0.19 percent change | Standard Error 2.28 |
| Ezetimibe | Percent Change From Baseline in Apolipoprotein B at Week 12 | -11.17 percent change | Standard Error 2.19 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -32.66 percent change | Standard Error 2.26 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -36.20 percent change | Standard Error 2.23 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -44.52 percent change | Standard Error 2.28 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -33.04 percent change | Standard Error 2.21 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -37.73 percent change | Standard Error 2.21 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -42.29 percent change | Standard Error 2.22 |
p-value: <0.00195% CI: [-50.45, -37.94]ANCOVA
p-value: <0.00195% CI: [-42.06, -29.69]ANCOVA
p-value: <0.00195% CI: [-38.55, -26.11]ANCOVA
p-value: <0.00195% CI: [-48.63, -36.32]ANCOVA
p-value: <0.00195% CI: [-44.07, -31.76]ANCOVA
p-value: <0.00195% CI: [-39.38, -27.07]ANCOVA
Secondary
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -2.89 percent change | Standard Error 2.4 |
| Placebo Q4W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -0.25 percent change | Standard Error 2.3 |
| Ezetimibe | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -15.53 percent change | Standard Error 2.36 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -37.95 percent change | Standard Error 2.38 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -39.68 percent change | Standard Error 2.34 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -48.04 percent change | Standard Error 2.4 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -37.94 percent change | Standard Error 2.24 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -42.14 percent change | Standard Error 2.24 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -47.36 percent change | Standard Error 2.25 |
p-value: <0.00195% CI: [-51.72, -38.58]ANCOVA
p-value: <0.00195% CI: [-43.29, -30.29]ANCOVA
p-value: <0.00195% CI: [-41.59, -28.52]ANCOVA
p-value: <0.00195% CI: [-53.33, -40.89]ANCOVA
p-value: <0.00195% CI: [-48.11, -35.67]ANCOVA
p-value: <0.00195% CI: [-43.92, -31.47]ANCOVA
Secondary
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set; missing data at Week 12 were imputed using LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -1.21 percent change | Standard Error 2.17 |
| Placebo Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -3.39 percent change | Standard Error 2.11 |
| Ezetimibe | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -16.65 percent change | Standard Error 1.99 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -30.07 percent change | Standard Error 2.15 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -33.13 percent change | Standard Error 2.12 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -38.70 percent change | Standard Error 2.17 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -32.07 percent change | Standard Error 2.05 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -34.60 percent change | Standard Error 2.05 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -39.97 percent change | Standard Error 2.06 |
p-value: <0.00195% CI: [-43.43, -31.54]ANCOVA
p-value: <0.00195% CI: [-37.79, -26.04]ANCOVA
p-value: <0.00195% CI: [-34.77, -22.95]ANCOVA
p-value: <0.00195% CI: [-42.29, -30.88]ANCOVA
p-value: <0.00195% CI: [-36.92, -25.51]ANCOVA
p-value: <0.00195% CI: [-34.39, -22.98]ANCOVA