Low-dose supplementation with omega 3 EPA/DHA or ALA did not significantly reduce the rate of major cardiovascular events among patients who previously had a heart attack, according to research published in the
New England Journal of Medicine.
For this double-blind, placebo-controlled, multicenter trial, Dutch researchers randomly assigned 4837 patients, 60-80 years of age (78% men), who had had a myocardial infarction and were receiving antihypertensive, antithrombotic and lipid-modifying therapy to receive for 40 months one of four trial margarines: a margarine supplemented with a combination of EPA and DHA (with a targeted additional daily intake of 400 mg of EPA/DHA), a margarine supplemented with ALA (with a targeted additional daily intake of 2 grams of ALA), a margarine supplemented with EPA/DHA and ALA or a placebo margarine.
The primary end point was the rate of major cardiovascular events, which comprised fatal and nonfatal cardiovascular events and cardiac interventions. Data were analyzed according to the intention-to-treat principle, with the use of Cox proportional-hazards models.
The patients consumed, on average, 18.8 grams of margarine per day, which resulted in additional intakes of 226 mg of EPA combined with 150 mg of DHA, 1.9 grams of ALA, or both, in the active-treatment groups. During the follow-up period, a major cardiovascular event occurred in 671 patients (13.9%). Neither EPA/DHA nor ALA reduced this primary end point.
In the prespecified subgroup of women, ALA, as compared with placebo and EPA/DHA alone, was associated with a reduction in the rate of major cardiovascular events that approached significance. The rate of adverse events did not differ significantly among the study groups.