- Adding omega-3 fatty acids to statin therapy in patients at high cardiovascular risk yields no benefit in terms of major adverse cardiac events (MACE).
- This randomized controlled trial was stopped early.
Why this matters
- Studies of omega-3s have yielded mixed results.
- This trial used a carboxylic acid formulation containing eicosapentaenoic acid and docosahexaenoic acid.
- Editor’s note says no one can be confident that omega-3s offer any health benefit, calls for postmarketing clinical trial of high-dose icosapent ethyl vs corn oil, the comparator used in this study.
- Editorial: findings counter positive results from REDUCE-IT trial, which used the icosapent ethyl formulation.
- 13,078 patients, 675 sites, 22 countries, enrolled October 30, 2014-June 14, 2017.
- Median treatment period for study drug: 38.2 (interquartile range, 30.5-44.9) months.
- Trial halted at interim analysis because results indicated low likelihood that the intervention was offering any clinical benefit.
- 12.0% in omega-3 group had the primary endpoint (MACE) vs 12.2% receiving corn oil.
- Those in the omega-3 group had more gastrointestinal complaints.
- Participants received 4 g/day omega-3 (n=6539) or corn oil (n=6539); continued regular therapies, including statins.
- Funding: AstraZeneca AB.
- All patients had high MACE risk, so generalization unclear.
- Single dose evaluated.