Table 1.
LDL‐C reductions by evolocumab dosing regimen and patient subgroup
| Subgroup | Evolocumab Q2W vs placebo | Evolocumab QM vs placebo | Evolocumab Q2W vs ezetimibe | Evolocumab QM vs ezetimibe |
|---|---|---|---|---|
| Treatment differencea in percent change from baseline in LDL‐C between evolocumab and control (95% CI) at the mean of 10 and 12 weeks | ||||
| Age, years | ||||
| <65 | −65.4 (−68.2, −62.6) | −65.3 (−68.3, −62.3) | −39.5 (−43.0, −35.9) | −44.0 (−47.2, −40.8) |
| ≥65 | −65.9 (−69.7, −62.0) | −64.4 (−68.8, −60.1) | −40.1 (−44.8, −35.4) | −35.6 (−40.1, −31.0) |
| Interaction P value (quantitative) | 0.86 | 0.74 | 0.83 | 0.003 |
| Interaction P value (qualitative) | NA | NA | NA | 0.5 |
| Gender | ||||
| Male | −68.5 (−71.8, −65.2) | −67.2 (−70.3, −64.1) | −43.0 (−47.3, −38.7) | −43.8 (−47.5, −40.1) |
| Female | −62.6 (−65.7, −59.4) | −62.9 (−66.8, −59.0) | −36.6 (−40.2, −33.0) | −38.8 (−42.5, −35.1) |
| Interaction P value (quantitative) | 0.01 | 0.09 | 0.025 | 0.06 |
| Interaction P value (qualitative) | 0.5 | NA | 0.5 | NA |
| Race | ||||
| Asian | −61.1 (−70.4, −51.8) | −66.3 (−75.6, −56.9) | −41.5 (−55.4, −27.7) | −52.9 (−62.2, −43.7) |
| Black | −72.6 (−82.5, −62.6) | −58.4 (−70.5, −46.3) | −44.3 (−58.9, −29.8) | −47.3 (−61.0, −33.6) |
| White | −65.7 (−68.1, −63.3) | −65.2 (−67.8, −62.5) | −39.2 (−42.2, −36.3) | −40.6 (−43.4, −37.7) |
| Other | −70.5 (−89.1, −52.0) | NA | NA | NA |
| Interaction P value (quantitative) | 0.37 | 0.52 | 0.75 | 0.034 |
| Interaction P value (qualitative) | NA | NA | NA | 0.875 |
| Ethnicity | ||||
| Hispanic | −77.4 (−92.6, −62.3) | −63.5 (−79.0, −48.1) | −36.6 (−46.8, −26.3) | −38.1 (−52.1, −24.2) |
| Non‐Hispanic | −64.9 (−67.2, −62.7) | −65.2 (−67.7, −62.7) | −39.8 (−42.7, −36.9) | −41.6 (−44.2, −38.9) |
| Interaction P value (quantitative) | 0.11 | 0.83 | 0.54 | 0.63 |
| Region | ||||
| Europe | −66.7 (−69.9, −63.6) | −63.2 (−66.8, −59.7) | −38.5 (−43.2, −33.7) | −40.6 (−44.7, −36.4) |
| North America | −65.6 (−69.4, −61.9) | −67.2 (−71.1, −63.2) | −41.4 (−45.0, −37.9) | −42.1 (−45.7, −38.5) |
| Asia Pacific | −57.8 (−64.3, −51.3) | −66.2 (−72.2, −60.2) | −36.5 (−45.0, −28.1) | −48.0 (−55.9, −40.0) |
| Interaction P value (quantitative) | 0.051 | 0.32 | 0.43 | 0.26 |
| Glucose tolerance | ||||
| Diabetic | −66.4 (−74.9, −57.9) | −62.0 (−72.6, −51.3) | −36.5 (−46.3, −26.6) | −42.5 (−52.2, −32.9) |
| Metabolic syndromeb | −70.0 (−74.1, −65.9) | −63.8 (−67.7, −59.8) | −40.9 (−44.8, −37.0) | −44.8 (−49.2, −40.4) |
| No diabetes or metabolic syndrome | −63.5 (−66.5, −60.5) | −66.7 (−69.7, −63.6) | −39.7 (−43.7, −35.6) | −39.1 (−42.5, −35.7) |
| Interaction P value (quantitative) | 0.04 | 0.42 | 0.70 | 0.12 |
| Interaction P value (qualitative) | 0.75 | NA | NA | NA |
| NCEP risk | ||||
| High | −65.0 (−69.1, −61.0) | −64.6 (−69.6, −59.6) | −40.4 (−46.6, −34.2) | −42.0 (−47.9, −36.1) |
| Moderately high | −72.6 (−80.5, −64.6) | −62.0 (−67.9, −56.1) | −48.0 (−57.8, −38.3) | −39.7 (−46.0, −33.4) |
| Moderate | −67.9 (−72.5, −63.4) | −64.9 (−69.5, −60.3) | −39.4 (−43.9, −34.9) | −42.1 (−47.0, −37.2) |
| Low | −61.8 (−65.7, −57.9) | −65.6 (−69.7, −61.6) | −36.7 (−40.9, −32.4) | −41.0 (−44.8, −37.2) |
| Interaction P value (quantitative) | 0.016 | 0.47 | 0.007 | 0.89 |
| Interaction P value (qualitative) | 0.875 | NA | 0.875 | NA |
| ESC/EAS risk | ||||
| Very high | −66.5 (−70.4, −62.5) | −62.7 (−67.2, −58.1) | −41.1 (−46.8, −35.3) | −40.4 (−45.7, −35.1) |
| High | −65.7 (−72.1, −59.3) | −68.9 (−74.9, −62.9) | −44.2 (−54.9, −33.4) | −45.5 (−57.8, −33.2) |
| Moderate | −66.0 (−69.7, −62.3) | −65.0 (−68.9, −61.1) | −37.9 (−41.8, −34.1) | −38.8 (−42.4, −35.3) |
| Low | −60.5 (−67.3, −53.8) | −67.8 (−73.7, −62.0) | −41.5 (−47.4, −35.7) | −48.5 (−54.1, −43.0) |
| Interaction P value (quantitative) | 0.53 | 0.19 | 0.65 | 0.009 |
| Interaction P value (qualitative) | NA | NA | NA | 0.875 |
Abbreviations: CI, confidence interval; EAS, European Atherosclerosis Society; ESC, European Society of Cardiology; LDL‐C, low‐density lipoprotein cholesterol; NA, not applicable; NCEP, National Cholesterol Education Program; Q2W, every 2 weeks; QM, monthly.
All treatment differences between evolocumab and control were statistically significant with a P value of <0.001.
Defined as no type 2 diabetes mellitus and three or more of the following conditions: fasting glucose ≥100 mg/dL, triglycerides ≥150 mg/dL, high blood pressure based on systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg or answer of “Yes” to the hypertension question on case report form (CRF), elevated waist circumference, or answer of “Yes” to the question “Low HDL” on CRF.