- Question
- Does adding icosapent ethyl to statin therapy reduce ischemic events in patients with elevated triglycerides and high cardiovascular risk?
- Design
- Multicenter, randomized, double-blind, placebo-controlled trial of 8179 patients with a median follow-up of 4.9 years.
- Population
- Patients with established cardiovascular disease or with diabetes and other risk factors, already receiving statins, with fasting triglycerides of 135 to 499 mg/dL and LDL cholesterol of 41 to 100 mg/dL. 70.7% were in secondary prevention.
- Intervention
- Icosapent ethyl (a highly purified eicosapentaenoic acid ethyl ester), 2 g twice daily (4 g total daily dose), added to statin therapy.
- Control
- Placebo, added to statin therapy.
- Primary outcome
- Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina.
- Results
- A primary end-point event occurred in 17.2% of the icosapent ethyl group versus 22.0% of the placebo group (HR 0.75; 95% CI 0.68 to 0.83; P<0.001). The key secondary end point (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) occurred in 11.2% versus 14.8% (HR 0.74; 95% CI 0.65 to 0.83; P<0.001).
- Safety
- Hospitalization for atrial fibrillation or flutter was more frequent with icosapent ethyl (3.1% vs. 2.1%; P=0.004). Serious bleeding occurred in 2.7% vs. 2.1% (P=0.06).
- Conclusion
- In patients with elevated triglycerides despite statin use, icosapent ethyl significantly reduced ischemic events, including cardiovascular death, compared with placebo.
- Why it matters
- It was the first trial to show that a triglyceride-targeted therapy added to statins reduces cardiovascular events in this patient profile, establishing icosapent ethyl as an additional option for cardiovascular prevention.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026