Omega-3 Fatty Acids for the Prevention of Recurrent Atrial Fibrillation - Omega-3 Fatty Acids for the Prevention of Recurrent Atrial Fibrillation

Nov 15, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Reliant Pharmaceuticals
Date Presented:
01/01/2010
Date Published:
01/01/2010
Date Updated:
11/15/2010
Original Posted Date:
11/15/2010
References

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.

Study Design

  • Placebo Controlled
  • Blinded
  • Randomized
  • Parallel

Patient Populations:

  • 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

Primary Endpoints:

  • First symptomatic recurrence of AF in patients with paroxysmal AF

Secondary Endpoints:

  • First symptomatic recurrence of AF in patients with persistent AF

Drug/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.

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.

Keywords: Follow-Up Studies, Body Mass Index, Fatty Acids, Omega-3, Docosahexaenoic Acids


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