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
Rauch B, Schiele R, Schneider S, Diller F, Victor N, Gohlke H, Gottwik M, Steinbeck G, Del Castillo U, Sack R, Worth H, Katus H, Spitzer W, Sabin G, Senges J, OMEGA Study Group
Circulation · 420 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2010-11-09 · Circulation · vol. 122 · número 21 · págs. 2152–2159
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 608 citas · más que el 100% de estudios similares · 47.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Acute Myocardial Infarction Research · Cardiac Health and Mental Health
- Palabras clave
- omega-3 fatty acids, omega-3 acid ethyl esters, acute myocardial infarction, sudden cardiac death, all-cause mortality, major adverse cardiovascular events, revascularization, guideline-directed therapy, percutaneous coronary intervention, coronary angiography, cardiovascular risk reduction
- MeSH
- humans, death, sudden, cardiac, myocardial infarction, fatty acids, omega-3, treatment outcome, combined modality therapy, patient discharge, myocardial revascularization, follow-up studies, feeding behavior, patient compliance, placebo effect, seafood, aged, middle aged, female, male, practice guidelines as topic
16 autores
- Bernhard Hermann Rauch🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Rudolf Schiele🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Steffen Schneider🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Frank Diller🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- N. Victor🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- H. Gohlke🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Martin G Gottwik🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Gerhard Steinbeck🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Ulrike Del Castillo🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Rudolf Sack🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- H. Worth🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Hugo Albert Katus🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Wilhelm Spitzer🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Georg V Sabin🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Jochen Senges🇩🇪Heidelberg University; Stiftung Institut für Herzinfarktforschung; Universitäts-Herzzentrum Freiburg-Bad Krozingen
- for the OMEGA Study Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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