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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. - - Methods and Results— - - OMEGA is a randomized, placebo-controlled, double-blind,...

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Main Authors: Rauch, Bernhard (Author) , Schiele, Rudolf (Author) , Schneider, Steffen (Author) , Diller, Frank (Author) , Victor, Norbert (Author) , Gohlke, Helmut (Author) , Gottwik, Martin (Author) , Steinbeck, Gerhard (Author) , Del Castillo, Ulrike (Author) , Sack, Rudolf (Author) , Worth, Heinrich (Author) , Katus, Hugo (Author) , Spitzer, Wilhelm (Author) , Sabin, Georg (Author) , Senges, Jochen (Author)
Format: Article (Journal)
Language:English
Published: 8 Nov 2010
In: Circulation
Year: 2010, Volume: 122, Issue: 21, Pages: 2152-2159
ISSN:1524-4539
DOI:10.1161/CIRCULATIONAHA.110.948562
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1161/CIRCULATIONAHA.110.948562
Verlag, lizenzpflichtig, Volltext: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.110.948562
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Author Notes:Bernhard Rauch, Rudolf Schiele, Steffen Schneider, Frank Diller, Norbert Victor, Helmut Gohlke, Martin Gottwik, Gerhard Steinbeck, Ulrike Del Castillo, Rudolf Sack, Heinrich Worth, Hugo Katus, Wilhelm Spitzer, Georg Sabin, Jochen Senges for the OMEGA Study Group
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Summary: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. - - Methods and 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. - - Clinical Trial Registration— - - URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251134.
Item Description:Gesehen am 10.05.2023
Physical Description:Online Resource
ISSN:1524-4539
DOI:10.1161/CIRCULATIONAHA.110.948562

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