Working Group on Future Clinical Research Directions on Omega-3 Fatty Acids and Cardiovascular Disease

Bethesda Marriott Hotel, Pooks Hill

June 2, 2004

Summary of Meeting

A Working Group meeting was held on June 2, 2004 chaired by Dr. Scott Grundy. The main objective of this working group was to review evidence-based reports on the effects of omega-3 fatty acids on CVD and CVD risk factors, recently released by the Agency of Healthcare Quality and Research, and to advise the NHLBI and Office of Dietary Supplements on future directions for research to fill gaps in knowledge on these issues.

The working group concluded that the body of evidence supports the hypothesis that ingestion of omega-3 fatty acids reduces CVD risk but that a definitive trial is needed. The evidence comes from cohort studies conducted in a variety of population samples, including U.S. samples, that consisted mostly of individuals without CVD. There have been few clinical trials conducted, which were generally in men who had experienced a heart attack, and mostly conducted in Europe and elsewhere, where background diets and medical care differ from the U.S. Much of the trial evidence is based on one large trial that had an open-label control group rather than a placebo control group. The benefit does not appear to function through effects on CVD risk factors, but seems to work through an independent mechanism, probably on arrhythmias and sudden cardiac death. The body of evidence is highly suggestive but not definitive that omega-3 fatty acids reduce CVD.

The working group recommended that a randomized clinical trial be conducted to test the effects of omega-3 fatty acids on CVD events. They recommended the trial be conducted in a high-risk population comprised of both high-risk primary prevention as well as secondary prevention participants using a design testing two dietary supplements (fish-based EPA and DHA as well as plant-based alpha- linolenic acid, the latter because of its high public health applicability) and a placebo control group. They recommended that ancillary studies should be encouraged to evaluate mechanisms by which omega-3 fatty acids may reduce CVD and to examine dose-response relationships. A report of the working group meeting is currently under preparation.

Participants List