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

Ingeborg A. Brouwer*, Peter L Zock, A. John Camm, Dirk Böcker, Richard N W Hauer, Eric F D Wever, Carla Dullemeijer, Jacintha E. Ronden, Martijn B. Katan, Andrzej Lubinski, Helga Buschler, Evert G. Schouten

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)2613-2619
Number of pages7
JournalJAMA
Volume295
Issue number22
DOIs
Publication statusPublished - 14 Jun 2006
Externally publishedYes

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