Trial Summary Omega-3 Fatty Acids for the Prevention of Recurrent Atrial Fibrillation Title: Omega-3 Fatty Acids for the Prevention of Recurrent Atrial Fibrillation
Trial Sponsor: Reliant Pharmaceuticals
Year Presented: 2010
Year Published: 2010
Topic(s): Arrhythmias, General Cardiology, Prevention/Vascular
Summary Posted: 11/15/2010
Writer: Anthony A. Bavry, M.D., M.P.H., F.A.C.C.
Author Disclosure: NOTHING TO DISCLOSE
Reviewer: Deepak L. Bhatt, M.D., M.P.H., F.A.C.C.
Reviewer Disclosure: RESEARCH/RESEARCH GRANTS: Astra Zeneca(SIGNIFICANT), Eisai(SIGNIFICANT), Sanofi Aventis(SIGNIFICANT), The Medicines Company(SIGNIFICANT), Ethicon(SIGNIFICANT), Bristol Myers Squibb(SIGNIFICANT), Heartscape(SIGNIFICANT), Cogentus(NONE), PLx Pharma(NONE), Takeda(NONE)
Description:
The goal of the trial was to evaluate treatment with prescription omega-3 fatty acids compared with placebo among patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
Hypothesis:
Prescription omega-3 fatty acids will be more effective in preventing recurrence of AF.
Drugs/Procedures Used:
Patients with symptomatic paroxysmal or persistent AF were randomized to prescription omega-3 fatty acids: 8 g daily for the first week, then 4 g daily (n = 332) versus placebo (n = 331).
Concomitant Medications:
At baseline, 39% of participants were receiving an angiotensin-converting enzymeinhibitor/angiotensin-receptor blocker, and 45% were receiving a statin.
Principal Findings:
Overall, 663 patients were randomized. The mean age of participants was 61 years, 44% were women, mean body mass index was 31 kg/m2, and paroxysmal AF was present in 82%.
The primary outcome, first recurrence of symptomatic AF/flutter in patients with paroxysmal AF occurred in 52% of the omega-3 group versus 48% of the placebo group (p = 0.26).
The secondary outcome, first recurrence of symptomatic AF/flutter in patients with persistent AF occurred in 50% versus 33% (p = 0.09), and the first recurrence of symptomatic AF/flutter among all patients occurred in 52% versus 46% (p = 0.08), respectively.
Eicosapentaenoic and docosahexaenoic acid blood levels were significantly higher in the omega-3 group versus the placebo group at 24 weeks (p < 0.001).
Interpretation:
Among patients with paroxysmal or persistent AF, treatment with omega-3 fatty acids was not effective in preventing symptomatic recurrence of AF. Prevention of AF remains a difficult clinical problem. The findings of this relatively large trial do not support the results of previous observational and smaller clinical trials.
Study Design:
Placebo Controlled. Blinded. Randomized. Parallel.
Primary Endpoints:
First symptomatic recurrence of AF in patients with paroxysmal AF
Secondary Endpoints:
First symptomatic recurrence of AF in patients with persistent AF
Patient Population:
Patients at least 18 years of age with symptomatic paroxysmal or persistent AF
Number of enrollees: 663
Duration of follow-up: 6 months
Mean patient age: 61 years
Percentage female: 44%
Exclusions:
Permanent AF
Secondary AF due to hypothyroidism or valvular heart disease
Current use of antiarrhythmic therapy
Use of amiodarone within the last 6 months
Prior ablation therapy for AF
Structural heart disease
References:
Kowey PR, Reiffel JA, Ellenbogen KA, Naccarelli GV, Pratt CM. Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial. JAMA 2010;Nov 15:[Epub ahead of print].
Presented by Dr. Peter Kowey at the American Heart Association Scientific Sessions, Chicago, IL, November 15, 2010.
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