REDUCE-IT: Cardiovascular Risk Reduction with Icosapent Ethyl
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA
New England Journal of Medicine • January 2019
Plain Language Summary
The REDUCE-IT trial was a groundbreaking study showing that taking high-dose purified fish oil (4 grams daily of EPA) significantly reduced heart attacks, strokes, and cardiovascular deaths by 25% in people with elevated triglycerides already taking statins. This led to FDA approval of prescription-strength omega-3 for reducing cardiovascular risk. The dose used (4g/day) is higher than typical supplements.
Key Findings
- 125% relative risk reduction in major adverse cardiovascular events (HR 0.75, 95% CI 0.68-0.83)
- 220% reduction in cardiovascular death
- 331% reduction in myocardial infarction
- 428% reduction in stroke
- 5Benefits seen regardless of baseline triglyceride levels
Abstract
The REDUCE-IT trial was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated the effects of icosapent ethyl (highly purified EPA omega-3) at a dose of 4g daily in patients with elevated triglycerides who were receiving statin therapy.
The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina.
Study Limitations
- Mineral oil placebo may have affected LDL-C levels in control group
- Study used purified EPA only, not EPA+DHA combination
- Higher rate of atrial fibrillation in treatment group (5.3% vs 3.9%)
- All participants were on statin therapy