• Myocardial Infarction
• Prevention & Screening Clinical Trials

Results from the OMEGA (NCT00251134) trial, presented by Jochen Senges, MD, Heart Center Ludwigshafen, University of Heidelberg, Germany, show that dietary supplementation with omega-3 fatty acids offers no additional benefits when added to optimal medical therapy (OMT) in patients who have suffered a heart attack.

The OMEGA trial primarily evaluated the effect of 1g daily of highly purified omega-3 acid ethylesters for 1 year in addition to OMT on the rate of sudden cardiac death (SCD) in patients with recent acute myocardial infarction (AMI). Secondary endpoints were total mortality, arrhythmic events, and the rates of reinfarction, stroke, and revascularization.

The study involved 3851 subjects with AMI (74.4% males; mean age 64 years), 59% of whom were diagnosed with ST elevated myocardial infarction (STEMI). Approximately 24% of the subjects had an ejection fraction <45%; 66% had hypertension, 50% had hypercholesterolemia, and 27% had diabetes. Coronary angiography was performed in 94% of patients, 78% of subjects underwent percutaneous coronary intervention, and 8% received fibrinolytic therapy.

Three to 14 days after AMI, patients were randomly assigned to 1 year of treatment with highly purified omega-3 fatty acids along with OMT (n=1937) or placebo (1 g olive oil; n=1909) and OMT. At the time of discharge from the hospital, 95% of patients were prescribed aspirin, 88% clopidogrel, 94% beta-blockers, 94% statins, and 83% ACE inhibitors.

After approximately 1 year of follow-up, there was no significant difference on the primary study endpoint of SCD or on any of the secondary endpoints between patients who were assigned to guidelines-based OMT alone or OMT plus omega-3 fatty acids (Table 1). At follow-up, triglyceride levels were very similar between groups (121 vs 127 mg/dL). No additional benefit for omega-3 supplementation in addition to OMT was evident across the prespecified subgroups that were analyzed.

The findings from OMEGA contradict those of previous studies, which suggested that supplementation with omega-3 fatty acids improves long-term survival. “In our study, there was a very low rate of cardiac events after acute myocardial infarction,” Dr. Senges said. “It would be incorrect to say that omega-3 fatty acids are not effective, but we could not find any additional benefits after optimizing medical therapy” after 12 months of therapy. The lower-than-anticipated event rate, resulting in a realized power of ∼50%, and the absence of longer-term follow-up are important limitations of this study.

• © 2009 MD Conference Express