Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia (REDUCE-IT)

REDUCE-IT randomized 8,179 statin-treated patients with elevated triglycerides (135-499 mg/dL) to 4 g/day icosapent ethyl (purified EPA ethyl ester) or mineral oil placebo. Over 4.9 years median follow-up, the primär composite endpoint (cardiovascular death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina) occurred in 17.2% vs 22.0% (HR 0.75, 95% CI 0.68-0.83, P<0.001). Cardiovascular death was reduced by 20% (4.3% vs 5.2%, HR 0.80, P=0.03). The key secondary endpoint (CV death, MI, stroke) was reduced by 26%. Number needed to treat was 21 for the primär endpoint. Atrial fibrillation was significantly increased (5.3% vs 3.9%, P<0.001), as was bleeding requiring hospitalization. The mineral oil placebo raised LDL cholesterol by 2.2%, which may have inflated the apparent benefit.

Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo.