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ALPHA OMEGA: n-3 fatty acids did not reduce major CV events in patients with history of MI
Kromhout D. Session 706007 – 706008.
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European Society of Cardiology Congress 2010
Low doses of n-3 fatty acids given in the form of margarine spreads did not lower the risk for major cardiovascular events in patients from the ALPHA OMEGA multicenter, randomized, double blind, placebo-controlled trial.
This study, the results of which were presented at the 2010 European Society of Cardiology Congress in Stockholm, included patients (n=4,837, mean age 69 years) enrolled from April 2002 to December 2006 after experiencing myocardial infarction. The patients were randomly assigned to different margarine spreads that provided low doses of n-3 fatty acids — 400 mg per day of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) or approximately 2 g per day of alpha-linolenic acid (ALA) — or placebo. Patients were followed for 40 months.
During follow-up, 671 patients developed a major CV event. According to study results, event risk was not reduced in patients receiving EPA plus DHA or ALA vs. placebo. Researchers noted a 27% reduction (HR=0.73; 95% CI, 0.51-1.03) in major CV events in women who received ALA, as well as a 49% reduction (HR=0.51; 95% CI, 0.27-0.97) in CHD mortality in patients who received EPA plus DHA.
“In the total patient population, low doses of n-3 fatty acids were not related to major CV events,” Daan Kromhout, MD, professor of public health research at Wageningen University, The Netherlands, and researcher on the study, said in the concluding comment of his presentation. “ALA may prevent major CV events in women, which needs confirmation.”
The ALPHA OMEGA Trial investigators are to be praised for this independent, investigator-initiated, food-based trial that was conducted with limited governmental funds. The pragmatic approach of the trial has to be reinforced, specifically the fact that this is food-based, because this is a model of a serious attempt to give a scientific basis to the wide-spreading advising of the potentially or hypothetical beneficial effect of food.
The pragmatic approach of the trial, the low dose of polyunsaturated 3 fatty acids and the relatively small sample size with respect of the event occurrence do not allow us to draw firm conclusions about the effect of the n-3 polyunsaturated fatty acids in this population of post-MI patients.
– Luigi Tavazzi , MD
Scientific Director, GVM Hospitals of Care and Research,
Cotignola, Italy
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