Brouwer IA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia (SOFA) (Abstract 1336)
The SOFA trial examined whether fish oil affected arrhythmias in patients with an implantable cardioverter defibrillator (ICD). The intake of very-long-chain omega-3 polyunsaturated fatty acids (PUFAs), found mainly in fish oil, has been thought to reduce the risk of sudden death, possibly through an anti-inflammatory effect or through changes in conductivity in the myocardium. Approximately 50% of all cardiovascular disease deaths are sudden and result from arrhythmias, stated SOFA lead investigator Ingeborg A. Brouwer, MD, from the Wageningen Centre for Food Sciences in the Netherlands.
Investigators focused on the incidence of recurrent spontaneous ventricular tachycardia (VT) and all-cause mortality in 546 patients with the ICD from 26 European centers. The participants were randomly selected to take 2 g of fish oil daily (n = 273) or placebo oil (n = 273). Follow-up included complete registration of ICD events at 12 months, with a primary end-point of time to first VT tachycardia/ventricular fibrillation (VT/VF) or death.
An analysis revealed a slight trend in favor of fish oil in event-free survival (P = .24). At 12 months, 30% of the patients taking fish oil had experienced either a life-threatening arrhythmia or death, compared with 33% of the placebo patients. Looking at the subgroups (VT at entry, VF at entry, prior MI, and an ejection fraction of less than 30% at entry), investigators found trends favoring fish oil in each, but none had a significant advantage. Among 342 patients with a prior MI, the trend was strongest (P = .086) for the primary endpoint, occurring in 28% of the fish oil patients and in 35% of the placebo patients. Dr. Brouwer concluded that there was no strong beneficial effect from omega-3 PUFAs on life-threatening cardiac arrhythmias for ICD patients, nor was there any indication of harm from fish oil.
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The Society’s discussant, Luigi Tavazzi, MD, from San Matteo University Hospital in Avia, Italy, pointed out that other trials have reasonably demonstrated reductions of life-threatening cardiac arrhythmias in post-MI patients taking fish oil. Dr. Tavazzi’s large, open-label GISSI-Heart Failure project had found significant benefits in this population. This ongoing randomized trial is now testing the effects of omega-3 fatty acid supplementation versus placebo in 7,057 patients taking fish oil over a period of three years, he said.