OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction.

Description

The aim of this study was to examine the effect of highly purified omega-3 fatty acids on the rate of sudden cardiac death in patients surviving acute myocardial infarction (AMI). The OMEGA trial is a randomized, placebo-controlled, double-blind, multicentre trial including 3,851 patients (female=25.6%; mean age=64.0 years). Patients were randomized 3 to 14 days after AMI and acute coronary angiography was performed in 93.8%, and acute percutaneous coronary intervention in 77.8% of all patients. The study drug was given over a period of 12 months in addition to current guideline-adjusted treatment of AMI. Results showed a low rate of sudden cardiac deaths, total mortality, and major adverse cerebrovascular and cardiovascular events within 1 year of follow-up after guideline-adjusted treatment and secondary prevention of AMI. However, these results suggest that supplementation with highly purified omega-3 fatty acids did not further reduce these low event rates. In his editorial comment, Eckel RH pointed out the interesting fact that, after the AMI, fish consumption increased significantly in both groups. He also discussed the fact that the dose used in the OMEGA trial was quite modest and that a more highly powered study with higher doses of omega-3 fatty acids would be interesting to perform.