Effect of fish oil on ventricular tachyarrhythmia and death in patients with implantable cardioverter defibrillators: the Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) randomized trial
Brouwer IA, Zock PL, Camm AJ, Böcker D, Hauer RN, Wever EF, Dullemeijer C, Ronden JE, Katan MB, Lubinski A, Buschler H, Schouten EG, SOFA Study Group
JAMA · 196 citas
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 independiente
- Universidad u hospital
- Wageningen University and Research
Según 1 financiador declarado.
Publicación
- Publicado
- 2006-06-13 · JAMA · vol. 295 · número 22 · págs. 2613–9
- Editorial
- American Medical Association
- Citado
- 287 citas · más que el 100% de estudios similares · 28.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 33 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Fatty Acid Research and Health · Cardiac electrophysiology and arrhythmias · Cardiac pacing and defibrillation studies
- Palabras clave
- fish oil, omega-3 polyunsaturated fatty acids, ventricular tachyarrhythmia, ventricular fibrillation, implantable cardioverter-defibrillator, sudden cardiac death, myocardial infarction
- MeSH
- humans, heart diseases, tachycardia, ventricular, fatty acids, omega-3, cause of death, proportional hazards models, double-blind method, defibrillators, implantable, dietary supplements, aged, middle aged, female, male
13 autores
- Ingeborg A. Brouwer🇳🇱Wageningen University & Research
- Peter L. Zock🇳🇱Wageningen University & Research
- A. John Camm🇬🇧St George's, University of London
- Dirk Böcker🇩🇪University of Münster
- Richard N.W. Hauer🇳🇱Utrecht University
- ERIC F.D. WEVER🇳🇱Utrecht University
- Carla Dullemeijer🇳🇱Wageningen University & Research
- Jacintha E. Ronden🇳🇱Cardialysis (Netherlands)
- Mira Katan🇳🇱Wageningen University & Research
- Andrzej Lubiński🇵🇱Gdańsk Medical University
- Helga Buschler
- Evert G. Schouten🇳🇱Wageningen University & Research
- for the SOFA Study Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Very-long-chain n-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish are thought to reduce risk of sudden death, possibly by reducing susceptibility to cardiac arrhythmia.
Objective
To study the effect of supplemental fish oil vs placebo on ventricular tachyarrhythmia or death.
Design, setting, and patients
The Study on Omega-3 Fatty acids and ventricular Arrhythmia (SOFA) was a randomized, parallel, placebo-controlled, double-blind trial conducted at 26 cardiology clinics across Europe. A total of 546 patients with implantable cardioverter-defibrillators (ICDs) and prior documented malignant ventricular tachycardia (VT) or ventricular fibrillation (VF) were enrolled between October 2001 and August 2004. Patients were randomly assigned to receive 2 g/d of fish oil (n = 273) or placebo (n = 273) for a median period of 356 days (range, 14-379 days).
Main outcome measure
Appropriate ICD intervention for VT or VF, or all-cause death.
Results
The primary end point occurred in 81 (30%) patients taking fish oil vs 90 (33%) patients taking placebo (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.64-1.16; P = .33). In prespecified subgroup analyses, the HR was 0.91 (95% CI, 0.66-1.26) for fish oil vs placebo in the 411 patients who had experienced VT in the year before the study, and 0.76 (95% CI, 0.52-1.11) for 332 patients with prior myocardial infarctions.
Conclusion
Our findings do not indicate evidence of a strong protective effect of intake of omega-3 PUFAs from fish oil against ventricular arrhythmia in patients with ICDs.
Trial registration
clinicaltrials.gov Identifier: NCT00110838.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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