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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
Open accessAbstract
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.
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Citations
Cites
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Self-citationFish Oil for the Treatment of Cardiovascular Disease
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Metadata
- Authors
- Brouwer, I. A., Zock, P. L., Camm, A. J., Böcker, D., Hauer, R. N. W., Wever, E. F. D., Dullemeijer, C., Ronden, J. E., Katan, M. B., Lubinski, A., Buschler, H., Schouten, E. G., & SOFA Study Group, F. T.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2006-06-14
- Volume
- 295
- Issue
- 22
- Pages
- 2613-9
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2099831545
- Cited by
- 287
- References
- 9
- FWCI
- 28.89
- Type
- journal article
- Language
- en
- Open access
- green
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