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.
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.
Brouwer
Ingeborg A
IA
Wageningen Centre for Food Sciences, Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands. ingeborg.brouwer@wur.nl
Zock
Peter L
PL
Camm
A John
AJ
Böcker
Dirk
D
Hauer
Richard N W
RN
Wever
Eric F D
EF
Dullemeijer
Carla
C
Ronden
Jacintha E
JE
Katan
Martijn B
MB
Lubinski
Andrzej
A
Buschler
Helga
H
Schouten
Evert G
EG
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*
D015525:Fatty Acids, Omega-3