NMA: Nonprescription Medicines Academy

Fish Oil Supplements Not Useful for Preventing Cardiovascular Disease or Death

May 29th, 2013

In the community-based Risk and Prevention Study in Italy, daily treatment with omega-3 fatty acids derived from fish failed to reduce cardiovascular mortality and morbidity.

The study enrolled 12,513 men and women with multiple cardiovascular risk factors or atherosclerotic vascular disease but not myocardial infarction. Patients were randomly assigned to receive 1 g of omega-3 fatty acids (polyunsaturated fatty acid ethyl esters with eicosapentaenoic acid and docosahexaenoic acid content not <85%, in a ratio that could range from 0.9:1 to 1.5:1) or an olive oil placebo, administered as a single daily capsule. The initially specified primary end point was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke; because the event rate was found to be lower than anticipated at 1 year, the primary end point was revised as time to death from cardiovascular causes or admission to the hospital for cardiovascular causes.

With a median of 5 years of follow-up, the primary end point occurred in 1,478 of 12,505 patients included in the analysis (11.8%). Of those 1,478 patients, 733 of 6,239 (11.7%) had received omega-3 fatty acids and 745 of 6,266 (11.9%) had received placebo (adjusted hazard ratio with omega-3 fatty acids, 0.97; 95% CI, 0.88–1.08; P = 0.58). The same null results were observed for all secondary end points.

N Engl J Med. 2013;368:1800-8.