Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.

Abstract (PubMed)

BACKGROUND: Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. RESULTS: After a median follow-up of 2.2 years, evolocumab significantly reduced the risk of the primary end point (1678 vs 1876 patients; hazard ratio, 0.85; 95% CI, 0.79–0.92; P<0.001) and the key secondary end point of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.73–0.88; P<0.001). CONCLUSIONS: Evolocumab significantly reduced the risk of cardiovascular events in patients with established cardiovascular disease receiving statin therapy.