title: Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial.
abstract: BACKGROUND
  Atrial fibrillation (AF) is common, yet there remains an unmet medical need for additional treatment options. Current pharmacological treatments have limited efficacy and significant adverse events. Limited data from small trials suggest omega-3 polyunsaturated fatty acids may provide a safe, effective treatment option for AF patients.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of prescription omega-3 fatty acids (prescription omega-3) for the prevention of recurrent symptomatic AF.
  
  
  METHODS
  Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter trial involving 663 US outpatient participants with confirmed symptomatic paroxysmal (n = 542) or persistent (n = 121) AF, with no substantial structural heart disease, and in normal sinus rhythm at baseline were recruited from November 2006 to July 2009 (final follow-up was January 2010).
  
  
  METHODS
  Prescription omega-3 (8 g/d) or placebo for the first 7 days; prescription omega-3 (4 g/d) or placebo thereafter through week 24.
  
  
  METHODS
  The primary end point was symptomatic recurrence of AF (first recurrence) in participants with paroxysmal AF. Secondary analyses included first recurrence in the persistent stratum and both strata combined. Participants were followed up for 6 months.
  
  
  RESULTS
  At 24 weeks, in the paroxysmal AF stratum, 129 of 269 participants (48%) in the placebo group and 135 of 258 participants (52%) in the prescription group had a recurrent symptomatic AF or flutter event. In the persistent AF stratum, 18 participants (33%) in the placebo group and 32 (50%) in the prescription group had documented symptomatic AF or flutter events. There was no difference between treatment groups for recurrence of symptomatic AF in the paroxysmal stratum (hazard ratio [HR], 1.15; 95% confidence interval [CI], 0.90-1.46; P = .26), in the persistent stratum (HR, 1.64; 95% CI, 0.92-2.92; P = .09), and both strata combined (HR, 1.22; 95% CI, 0.98-1.52; P = .08). Other, secondary end points were supportive of the primary result. A total of 5% of those receiving placebo and 4% of those receiving prescription omega-3 discontinued due to adverse events. Eicosapentaenoic and docosahexaenoic acid blood levels were significantly higher in the prescription group than in the placebo group at weeks 4 and 24.
  
  
  CONCLUSIONS
  Among participants with paroxysmal AF, 24-week treatment with prescription omega-3 compared with placebo did not reduce recurrent AF over 6 months.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00402363.
authors.affiliation: Division of Cardiovascular Diseases, Lankenau Institute for Medical Research, Wynnewood, Pennsylvania 19096, USA. KoweyP@mlhs.org
authors.forename: Peter R
authors.initials: PR
authors.lastname: Kowey
authors.forename: James A
authors.initials: JA
authors.lastname: Reiffel
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Ellenbogen
authors.forename: Gerald V
authors.initials: GV
authors.lastname: Naccarelli
authors.forename: Craig M
authors.initials: CM
authors.lastname: Pratt
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000188:drug therapy*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D015525:Fatty Acids, Omega-3