Pharmacological supplementation with 1 g of omega-3 supplements for 1 year did not reduce recurrent atrial fibrillation in patients with normal sinus rhythm, a prospective, randomized trial reported.
Researchers conducted FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation Fish Oil Research with omega-3 for Atrial fibrillation Recurrence Delaying). This was a double-blind, placebo-controlled, multicenter trial in 42 Argentinian centers with 586 outpatients with confirmed symptomatic paroxysmal atrial fibrillation. Among the cohort, 428 required cardioversion, 55 had at least 2 episodes of atrial fibrillation in the previous 6 months, and 103 had both.
FORWARD was stopped early because the trial's Steering Committee determined that a slower-than-expected recruitment rate and lower event rates meant that continuing it would not likely lead to a positive finding.
Results appeared Dec. 19 in the Journal of the American College of Cardiology.
There were no significant differences between patients allocated to placebo and those who received omega-3 supplements. At 12 months, 56 of 297 participants (18.9%) in the placebo group and 69 of 289 participants (24.0%) in the omega-3 group had a recurrent symptomatic atrial fibrillation (hazard ratio [HR], 1.28; 95% confidence interval [CI], 0.90 to 1.83; P=0.17).
Also, there was no difference between treatment and control groups for a composite of all-cause mortality, nonfatal stroke, nonfatal acute myocardial infarction, systemic embolism, heart failure development, or severe bleeding that occurred in 20 (6.7%) receiving placebo and 16 (5.5%) patients receiving omega-3s, (HR, 0.86; 95% CI, 0.44 to 1.66; P=0.65).
Although the FORWARD trial was stopped early, which might result in an underpowered clinical trial unable to verify its hypothesis, researchers noted of this and another trial of omega-3s, "[T]ogether they contributed >70% of patients and events in clinical research of this question and might constitute a refutation of the hypothesis of a protective role of these agents for this indication."