Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.

Abstract (PubMed)

BACKGROUND: Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter. The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. RESULTS: A total of 8179 patients were enrolled. The primary end point occurred in 17.2% in the icosapent ethyl group versus 22.0% in the placebo group (hazard ratio, 0.75; 95% CI, 0.68–0.83; P<0.001). CONCLUSIONS: Among patients with elevated triglyceride levels despite statin therapy, icosapent ethyl significantly reduced the incidence of ischemic events.