title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00110838.
authors.affiliation: Wageningen Centre for Food Sciences, Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands. ingeborg.brouwer@wur.nl
authors.forename: Ingeborg A
authors.initials: IA
authors.lastname: Brouwer
authors.forename: Peter L
authors.initials: PL
authors.lastname: Zock
authors.forename: A John
authors.initials: AJ
authors.lastname: Camm
authors.forename: Dirk
authors.initials: D
authors.lastname: Böcker
authors.forename: Richard N W
authors.initials: RN
authors.lastname: Hauer
authors.forename: Eric F D
authors.initials: EF
authors.lastname: Wever
authors.forename: Carla
authors.initials: C
authors.lastname: Dullemeijer
authors.forename: Jacintha E
authors.initials: JE
authors.lastname: Ronden
authors.forename: Martijn B
authors.initials: MB
authors.lastname: Katan
authors.forename: Andrzej
authors.initials: A
authors.lastname: Lubinski
authors.forename: Helga
authors.initials: H
authors.lastname: Buschler
authors.forename: Evert G
authors.initials: EG
authors.lastname: Schouten
mesh_terms: D000368:Aged; D002423:Cause of Death; D017147:Defibrillators, Implantable; D019587:Dietary Supplements; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D006331:Heart Diseases / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D017180:Tachycardia, Ventricular / Q000453:epidemiology*
chemical_list: D015525:Fatty Acids, Omega-3