- Question
- Does adding a carboxylic acid formulation of omega-3 fatty acids (EPA+DHA) to usual statin therapy reduce major adverse cardiovascular events in high-risk patients with hypertriglyceridemia and low HDL-C?
- Design
- Double-blind, randomized, multicenter trial of 13078 patients at 675 hospitals in 22 countries. It was stopped early, after 1384 primary end point events (of 1600 planned), because an interim analysis showed a low probability of clinical benefit.
- Population
- Statin-treated patients at high cardiovascular risk with hypertriglyceridemia and low HDL-C. Mean age was 62.5 years, 35% were women and 70% had diabetes; median triglycerides were 240 mg/dL and median LDL-C was 75.0 mg/dL.
- Intervention
- Omega-3 CA (EPA+DHA) 4 g/day (n = 6539) added to background therapy, including statins.
- Control
- Corn oil 4 g/day (n = 6539), intended as an inert comparator, added to the same background therapy.
- Primary outcome
- Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.
- Results
- The primary end point occurred in 785 patients (12.0%) with omega-3 CA and 795 (12.2%) with corn oil (HR 0.99; 95% CI 0.90-1.09; P = .84), with no significant difference.
- Safety
- Gastrointestinal adverse events were more frequent with omega-3 CA (24.7%) than with corn oil (14.7%).
- Conclusion
- In statin-treated patients at high cardiovascular risk, omega-3 CA did not reduce major adverse cardiovascular events compared with corn oil.
- Why it matters
- The trial did not support the use of this omega-3 formulation to prevent cardiovascular events and fueled the debate over the role of omega-3 fatty acids and the choice of comparator in such trials.
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 14, 2026