Hyperlipidemia
Conditions
Keywords
Hypercholesterolemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Brief summary
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
Interventions
BIOLOGICALEvolocumab
Administered by subcutaneous injection
Administered by subcutaneous injection
Sponsors
The TIMI Study Group
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 to ≤ 80 years of age * On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks * Fasting LDL-C ≥ 85 mg/dL * Fasting triglycerides ≤ 400 mg/dL
Exclusion criteria
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization * Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) \> 8.5%) * Uncontrolled hypertension * New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction \< 30% * Uncontrolled cardiac arrhythmia
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
Canada, Czechia, Denmark, Hungary, United States
Participant flow
Recruitment details
This study enrolled adults aged 18 - 80 years who were on a statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL. The first patient enrolled on 18 July 2011 and the last patient enrolled on 22 December 2011.
Pre-assignment details
Eligible participants were randomized equally into 1 of 8 treatment groups. Randomization was stratified by screening LDL-C level (\< 130 mg/dL or ≥ 130 mg/dL) and ezetimibe use at baseline (yes or no).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Q2W Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | 78 |
| Placebo Q4W Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. | 77 |
| Evolocumab 70 mg Q2W Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | 79 |
| Evolocumab 105 mg Q2W Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | 79 |
| Evolocumab 140 mg Q2W Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | 78 |
| Evolocumab 280 mg Q4W Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | 79 |
| Evolocumab 350 mg Q4W Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | 79 |
| Evolocumab 420 mg Q4W Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | 80 |
| Total | 629 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo Q4W | Placebo Q2W | Total | Evolocumab 420 mg Q4W | Evolocumab 350 mg Q4W | Evolocumab 280 mg Q4W | Evolocumab 140 mg Q2W | Evolocumab 105 mg Q2W | Evolocumab 70 mg Q2W |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 9.6 | 60.2 years STANDARD_DEVIATION 8.8 | 60.5 years STANDARD_DEVIATION 9.5 | 60.9 years STANDARD_DEVIATION 10.3 | 61.9 years STANDARD_DEVIATION 8.8 | 60.3 years STANDARD_DEVIATION 8.4 | 62.4 years STANDARD_DEVIATION 10.2 | 58.8 years STANDARD_DEVIATION 9.7 | 59.4 years STANDARD_DEVIATION 9.9 |
| Apolipoprotein B/Apolipoprotein A-1 Ratio | 0.676 ratio STANDARD_DEVIATION 0.194 | 0.660 ratio STANDARD_DEVIATION 0.155 | 0.670 ratio STANDARD_DEVIATION 0.184 | 0.653 ratio STANDARD_DEVIATION 0.177 | 0.687 ratio STANDARD_DEVIATION 0.175 | 0.662 ratio STANDARD_DEVIATION 0.199 | 0.649 ratio STANDARD_DEVIATION 0.155 | 0.695 ratio STANDARD_DEVIATION 0.219 | 0.675 ratio STANDARD_DEVIATION 0.191 |
| Apolipoprotein B Concentration | 101.6 mg/dL STANDARD_DEVIATION 20 | 99.9 mg/dL STANDARD_DEVIATION 17 | 100.9 mg/dL STANDARD_DEVIATION 19 | 99.9 mg/dL STANDARD_DEVIATION 18.6 | 102.6 mg/dL STANDARD_DEVIATION 18.9 | 101.3 mg/dL STANDARD_DEVIATION 21.2 | 98.8 mg/dL STANDARD_DEVIATION 16.6 | 103.6 mg/dL STANDARD_DEVIATION 22.3 | 99.9 mg/dL STANDARD_DEVIATION 16.8 |
| LDL-C Concentration | 124.9 mg/dL STANDARD_DEVIATION 30.6 | 122.2 mg/dL STANDARD_DEVIATION 27.1 | 122.8 mg/dL STANDARD_DEVIATION 27.7 | 120.8 mg/dL STANDARD_DEVIATION 26.5 | 123.2 mg/dL STANDARD_DEVIATION 27.1 | 122.0 mg/dL STANDARD_DEVIATION 28.8 | 120.9 mg/dL STANDARD_DEVIATION 25.1 | 127.4 mg/dL STANDARD_DEVIATION 32.1 | 121.4 mg/dL STANDARD_DEVIATION 24.4 |
| Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration | 150.2 mg/dL STANDARD_DEVIATION 36.5 | 146.9 mg/dL STANDARD_DEVIATION 29.9 | 147.4 mg/dL STANDARD_DEVIATION 31.8 | 144.4 mg/dL STANDARD_DEVIATION 31.2 | 150.0 mg/dL STANDARD_DEVIATION 29.1 | 146.3 mg/dL STANDARD_DEVIATION 33.3 | 145.3 mg/dL STANDARD_DEVIATION 26.2 | 151.2 mg/dL STANDARD_DEVIATION 37.2 | 145.3 mg/dL STANDARD_DEVIATION 29.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 3 participants | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 0 participants | 12 participants | 1 participants | 2 participants | 2 participants | 1 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 6 participants | 50 participants | 9 participants | 4 participants | 8 participants | 9 participants | 8 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 6 participants | 1 participants | 21 participants | 2 participants | 0 participants | 1 participants | 6 participants | 0 participants | 5 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 3 participants | 0 participants | 0 participants | 2 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 71 participants | 77 participants | 608 participants | 78 participants | 79 participants | 78 participants | 72 participants | 79 participants | 74 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 3 participants | 0 participants | 1 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 74 participants | 72 participants | 558 participants | 70 participants | 72 participants | 64 participants | 67 participants | 67 participants | 72 participants |
| Sex: Female, Male Female | 41 Participants | 42 Participants | 319 Participants | 44 Participants | 38 Participants | 40 Participants | 45 Participants | 25 Participants | 44 Participants |
| Sex: Female, Male Male | 36 Participants | 36 Participants | 310 Participants | 36 Participants | 41 Participants | 39 Participants | 33 Participants | 54 Participants | 35 Participants |
| Stratification Factor: Baseline Ezetimibe Use No | 69 participants | 71 participants | 572 participants | 73 participants | 72 participants | 72 participants | 71 participants | 72 participants | 72 participants |
| Stratification Factor: Baseline Ezetimibe Use Yes | 8 participants | 7 participants | 57 participants | 7 participants | 7 participants | 7 participants | 7 participants | 7 participants | 7 participants |
| Stratification Factor: LDL-C Level < 130 mg/dL | 51 participants | 51 participants | 412 participants | 53 participants | 52 participants | 51 participants | 52 participants | 51 participants | 51 participants |
| Stratification Factor: LDL-C Level ≥ 130 mg/dL | 26 participants | 27 participants | 217 participants | 27 participants | 27 participants | 28 participants | 26 participants | 28 participants | 28 participants |
| Total Cholesterol/HDL-C ratio | 4.057 ratio STANDARD_DEVIATION 1.303 | 3.940 ratio STANDARD_DEVIATION 1.016 | 4.008 ratio STANDARD_DEVIATION 1.184 | 3.885 ratio STANDARD_DEVIATION 1.09 | 4.118 ratio STANDARD_DEVIATION 0.963 | 4.007 ratio STANDARD_DEVIATION 1.3 | 3.932 ratio STANDARD_DEVIATION 1.022 | 4.128 ratio STANDARD_DEVIATION 1.473 | 4.002 ratio STANDARD_DEVIATION 1.243 |
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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 78 | 17 / 77 | 20 / 79 | 28 / 79 | 27 / 78 | 21 / 79 | 23 / 79 | 30 / 80 |
| serious Total, serious adverse events | 4 / 78 | 0 / 77 | 0 / 79 | 1 / 79 | 4 / 78 | 2 / 79 | 2 / 79 | 2 / 80 |
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 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 | 2.76 percent change | Standard Error 2.39 |
| Placebo Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -0.98 percent change | Standard Error 2.51 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -39.06 percent change | Standard Error 2.39 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -57.48 percent change | Standard Error 2.39 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -63.34 percent change | Standard Error 2.4 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -42.82 percent change | Standard Error 2.52 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -50.98 percent change | Standard Error 2.51 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -51.31 percent change | Standard Error 2.53 |
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: [-71.48, -60.72]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: [-65.61, -54.88]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: [-47.18, -36.45]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: [-56.04, -44.62]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: [-55.69, -44.31]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: [-47.55, -36.13]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 data at Week 12 were imputed using LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Change From Baseline in LDL-C at Week 12 | -0.2 mg/dL | Standard Error 3.4 |
| Placebo Q4W | Change From Baseline in LDL-C at Week 12 | -3.2 mg/dL | Standard Error 3.3 |
| Evolocumab 70 mg Q2W | Change From Baseline in LDL-C at Week 12 | -50.9 mg/dL | Standard Error 3.4 |
| Evolocumab 105 mg Q2W | Change From Baseline in LDL-C at Week 12 | -77.6 mg/dL | Standard Error 3.5 |
| Evolocumab 140 mg Q2W | Change From Baseline in LDL-C at Week 12 | -79.5 mg/dL | Standard Error 3.4 |
| Evolocumab 280 mg Q4W | Change From Baseline in LDL-C at Week 12 | -53.7 mg/dL | Standard Error 3.3 |
| Evolocumab 350 mg Q4W | Change From Baseline in LDL-C at Week 12 | -64.3 mg/dL | Standard Error 3.3 |
| Evolocumab 420 mg Q4W | Change From Baseline in LDL-C at Week 12 | -64.3 mg/dL | Standard Error 3.3 |
p-value: <0.00195% CI: [-87, -71.5]ANCOVA
p-value: <0.00195% CI: [-85.2, -69.6]ANCOVA
p-value: <0.00195% CI: [-58.5, -43]ANCOVA
p-value: <0.00195% CI: [-68.6, -53.7]ANCOVA
p-value: <0.00195% CI: [-68.5, -53.7]ANCOVA
p-value: <0.00195% CI: [-58, -43.1]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 | -0.30 percent change | Standard Error 2.13 |
| Placebo Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -0.35 percent change | Standard Error 2.38 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -35.04 percent change | Standard Error 2.13 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -47.60 percent change | Standard Error 2.12 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -53.73 percent change | Standard Error 2.14 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -34.11 percent change | Standard Error 2.4 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -42.74 percent change | Standard Error 2.39 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 | -43.28 percent change | Standard Error 2.4 |
p-value: <0.00195% CI: [-58.23, -48.65]ANCOVA
p-value: <0.00195% CI: [-52.08, -42.52]ANCOVA
p-value: <0.00195% CI: [-39.53, -29.97]ANCOVA
p-value: <0.00195% CI: [-48.36, -37.5]ANCOVA
p-value: <0.00195% CI: [-47.81, -36.98]ANCOVA
p-value: <0.00195% CI: [-39.2, -28.33]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 | 5.86 percent change | Standard Error 2.15 |
| Placebo Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 3.22 percent change | Standard Error 2.25 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -28.88 percent change | Standard Error 2.15 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -44.29 percent change | Standard Error 2.14 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -50.59 percent change | Standard Error 2.15 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -31.16 percent change | Standard Error 2.26 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -37.55 percent change | Standard Error 2.26 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -38.81 percent change | Standard Error 2.27 |
p-value: <0.00195% CI: [-61.28, -51.61]ANCOVA
p-value: <0.00195% CI: [-54.97, -45.33]ANCOVA
p-value: <0.00195% CI: [-39.56, -29.92]ANCOVA
p-value: <0.00195% CI: [-47.16, -36.9]ANCOVA
p-value: <0.00195% CI: [-45.88, -35.66]ANCOVA
p-value: <0.00195% CI: [-39.51, -29.25]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 | 2.21 percent change | Standard Error 2.2 |
| Placebo Q4W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -1.26 percent change | Standard Error 2.26 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -36.23 percent change | Standard Error 2.2 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -53.21 percent change | Standard Error 2.2 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -59.19 percent change | Standard Error 2.21 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -39.05 percent change | Standard Error 2.27 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -47.05 percent change | Standard Error 2.26 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | -48.83 percent change | Standard Error 2.27 |
p-value: <0.00195% CI: [-66.37, -56.43]ANCOVA
p-value: <0.00195% CI: [-60.37, -50.47]ANCOVA
p-value: <0.00195% CI: [-43.39, -33.48]ANCOVA
p-value: <0.00195% CI: [-52.72, -42.44]ANCOVA
p-value: <0.00195% CI: [-50.92, -40.67]ANCOVA
p-value: <0.00195% CI: [-42.94, -32.65]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 | 2.64 percent change | Standard Error 1.97 |
| Placebo Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -2.00 percent change | Standard Error 1.9 |
| Evolocumab 70 mg Q2W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -28.76 percent change | Standard Error 1.97 |
| Evolocumab 105 mg Q2W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -40.73 percent change | Standard Error 1.97 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -45.09 percent change | Standard Error 1.98 |
| Evolocumab 280 mg Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -29.73 percent change | Standard Error 1.91 |
| Evolocumab 350 mg Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -37.97 percent change | Standard Error 1.91 |
| Evolocumab 420 mg Q4W | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | -37.66 percent change | Standard Error 1.92 |
p-value: <0.00195% CI: [-52.18, -43.29]ANCOVA
p-value: <0.00195% CI: [-47.81, -38.94]ANCOVA
p-value: <0.00195% CI: [-35.83, -26.97]ANCOVA
p-value: <0.00195% CI: [-39.99, -31.32]ANCOVA
p-value: <0.00195% CI: [-40.29, -31.65]ANCOVA
p-value: <0.00195% CI: [-32.06, -23.39]ANCOVA