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.
BACKGROUND
There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction.


RESULTS
OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (n=3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (P=0.84); total mortality, 4.6% and 3.7% (P=0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (P=0.1); and revascularization in survivors, 27.6% and 29.1% (P=0.34).


CONCLUSIONS
Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251134.
Institut für Herzinfarktforschung Ludwigshafenan der Universität Heidelberg, Germany. rauch@zar-kardio-ludwigshafen.de
Bernhard
B
Rauch
Rudolf
R
Schiele
Steffen
S
Schneider
Frank
F
Diller
Norbert
N
Victor
Helmut
H
Gohlke
Martin
M
Gottwik
Gerhard
G
Steinbeck
Ulrike
U
Del Castillo
Rudolf
R
Sack
Heinrich
H
Worth
Hugo
H
Katus
Wilhelm
W
Spitzer
Georg
G
Sabin
Jochen
J
Senges
D000368:Aged; D003131:Combined Modality Therapy; D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000517:prevention & control*; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage* / Q000009:adverse effects; D005247:Feeding Behavior; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality; D009204:Myocardial Revascularization; D010349:Patient Compliance; D010351:Patient Discharge; D015990:Placebo Effect; D017410:Practice Guidelines as Topic; D017747:Seafood; D016896:Treatment Outcome
D015525:Fatty Acids, Omega-3