Efficacy and safety of prescription omega-3-acid ethyl esters for the prevention of recurrent symptomatic atrial fibrillation: a prospective study.
BACKGROUND
Atrial fibrillation (AF) continues to be one of the most common cardiac problems, placing an expanding burden on the public health system. In several circumstances, AF can increase the risk of stroke and heart failure. Current pharmacologic treatment options are associated with the potential for significant adverse events, which often outweigh the benefits of achieving sinus rhythm. There is evidence to suggest antiarrhythmic benefits of omega-3 polyunsaturated fatty acids; however, the data are not conclusive. This study is designed to further assess the effect of prescription omega-3 ethyl esters (P-OM3) in the prevention of recurrent AF in patients with AF without (significant) structural heart disease.


METHODS
This trial is a 6-month randomized, double-blind, placebo-controlled, parallel-study design. Patients with confirmed symptomatic paroxysmal or persistent AF (5:1 ratio) will be randomized to receive either 4 g/d P-OM3 (Lovaza; GlaxoSmithKline, Research Triangle Park, NC) or placebo. The primary end point is the first recurrence of symptomatic AF among patients with paroxysmal AF. Secondary end points include the first recurrence of symptomatic AF among all patients. Safety will be assessed regularly.


CONCLUSIONS
This is the first randomized blinded trial to assess the antiarrhythmic effects of 4 g/d P-OM3 in paroxysmal AF.
Pratt
Craig M
CM
Methodist DeBakey Heart & Vascular Center, 6565 Fannin Street, F1001, Houston, TX 77030, USA. cpratt@tmhs.org
Reiffel
James A
JA
Ellenbogen
Kenneth A
KA
Naccarelli
Gerald V
GV
Kowey
Peter R
PR
D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000517:prevention & control*; D004281:Docosahexaenoic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D023381:Endpoint Determination; D006801:Humans; D015337:Multicenter Studies as Topic; D011446:Prospective Studies; D012008:Recurrence; D012107:Research Design
D000889:Anti-Arrhythmia Agents; D004338:Drug Combinations; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor