TY - JOUR
T1 - Efficacy and safety of prescription omega-3-acid ethyl esters for the prevention of recurrent symptomatic atrial fibrillation
T2 - A prospective study
AU - Pratt, Craig M.
AU - Reiffel, James A.
AU - Ellenbogen, Kenneth A.
AU - Naccarelli, Gerald V.
AU - Kowey, Peter R.
PY - 2009/8
Y1 - 2009/8
N2 - 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. Conclusion: This is the first randomized blinded trial to assess the antiarrhythmic effects of 4 g/d P-OM3 in paroxysmal AF.
AB - 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. Conclusion: This is the first randomized blinded trial to assess the antiarrhythmic effects of 4 g/d P-OM3 in paroxysmal AF.
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U2 - 10.1016/j.ahj.2009.05.024
DO - 10.1016/j.ahj.2009.05.024
M3 - Article
C2 - 19619690
AN - SCOPUS:67650567090
SN - 0002-8703
VL - 158
SP - 163-169.e3
JO - American Heart Journal
JF - American Heart Journal
IS - 2
ER -