Clinical trials of nonstatin therapy
| Trial | Intervention | Study population, prevention goal | Composite primary outcome | Major findings |
|---|---|---|---|---|
| IMPROVE-IT 201512 | Simvastatin plus ezetimibe vs simvastatin only | 18,144 patients with recent acute coronary syndrome and LDL cholesterol 50–125 mg/dL Secondary prevention | Cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization | Simvastatin + ezetimibe combination reduced primary end point at 7 years (32.7% vs 34.7%) Driven primarily by myocardial infarction and stroke No mortality effect |
| FOURIER 201718 | Evolocumab plus statin vs statin alone | 27,564 patients with ASCVD and LDL cholesterol ≥ 70 mg/dL despite statin use Secondary prevention | Cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization | Evolocumab reduced primary end point at 2.2 years (9.8% vs 11.3%) Driven by myocardial infarction, stroke, need for revascularization No mortality effect |
| ODYSSEY 201819 | Alirocumab + statin vs statin alone | 18,924 patients with recent acute coronary syndrome and elevated lipids despite statin use Secondary prevention | Cardiovascular death, myocardial infarction, stroke, or unstable angina | Alirocumab reduced primary end point at 2.8 years (9.5% vs 11.1%) No significant mortality benefit |
| CLEAR 20238 | Bempedoic acid vs placebo | 13,970 patients with ASCVD or at high risk and unable to take statins Primary and secondary prevention | Cardiovascular death, myocardial infarction, stroke, or coronary revascularization | Bempedoic acid reduced primary end point at 40.6 months (11.7% vs 13.3%) No significant effect on fatal or nonfatal stroke, cardiovascular death, or all-cause mortality |
ASCVD = atherosclerotic cardiovascular disease; LDL = low-density lipoprotein