- 8,179 participants, all with either established cardiovascular disease or diabetes or other risk factors. All participants had high blood triglycerides, and they were undergoing successful statin therapy.
- Participants were randomly assigned to receive 4g/day of EPA or placebo, and they were followed for a median of 4.9 years.
- REDUCE-IT found that the treatment lowered the risk of major cardiovascular events by 25%, and that the risk of other cardiovascular outcomes (like stroke, or myocardial infarction) were reduced by a similar factor.
Residual cardiovascular risk persists despite statins, yet outcome studies of lipid-targeted therapies beyond low-density lipoprotein cholesterol (LDL-C) have not demonstrated added benefit. Triglyceride elevation is an independent risk factor for cardiovascular events. High-dose eicosapentaenoic acid (EPA) reduces triglyceride-rich lipoproteins without raising LDL-C. Omega-3s have postulated pleiotropic cardioprotective benefits beyond triglyceride-lowering. To date, no large, multinational, randomized clinical trial has proved that lowering triglycerides on top of statin therapy improves cardiovascular outcomes.
The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) is a phase 3b randomized, double-blinded, placebo-controlled trial of icosapent ethyl, a highly purified ethyl ester of EPA, vs placebo. The main objective is to evaluate whether treatment with icosapent ethyl reduces ischemic events in statin-treated patients with high triglycerides at elevated cardiovascular risk.
REDUCE-IT enrolled men or women age ?45?years with established cardiovascular disease or age ?50?years with diabetes mellitus and 1 additional risk factor. Randomization required fasting triglycerides ?150?mg/dL and <500?mg/dL and LDL-C >40?mg/dL and ?100?mg/dL with stable statin (± ezetimibe) ?4?weeks prior to qualifying measurements. The primary endpoint is a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary endpoint is the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Several secondary, tertiary, and exploratory endpoints will be assessed.
Approximately 8000 patients have been randomized at approximately 470 centers worldwide. Follow-up will continue in this event-driven trial until approximately 1612 adjudicated primary-efficacy endpoint events have occurred.