P-OM3 trial - Summary & Results
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http://www.theheart.org/web_slides/1171735.do One of the largest studies to examine the effect of omega-3 polyunsaturated fatty acids (PUFA) on AF
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P-OM3 trial - Summary & Results
- 1. P-OM3
- 2. P-OM3 PR Kowey (Lankenau Institute for medical Research, Wynnewood, PA) American Heart Association 2010 Scientific Sessions • One of the largest studies to examine the effect of omega-3 polyunsaturated fatty acids (PUFA) on AF • Population and treatment: 663 outpatients with documented symptomatic paroxysmal or persistent AF (n=542 and n=121, respectively) without significant structural heart disease and initially in sinus rhythm Randomized to receive placebo or the prescription omega-3 PUFA capsules (fish oil) at 8 g/day for the first seven days followed by 4 g/day for total of 24 weeks • Primary outcome: First recurrence of symptomatic AF or atrial flutter
- 3. P-OM3: Results • Fish oil did not show an effect on the primary end point but there were trends toward a reduction in average ventricular rate during the first AF recurrence and a reduction in triglyceride levels at week 24 Rate of primary end point by AF type and treatment group and HR for active therapy vs placebo Patient group Placebo (%) Omega-3 PUFA (%) HR (95% CI) p Paroxysmal AF* (n=542) 48 52 1.15 (0.90–1.46) 0.26 Persistent AF (n=121) 33 50 1.64 (0.92–2.92) 0.09 Any AF (all patients) 46 52 1.22 (0.98–1.52) 0.08
- 4. P-OM3: Commentary* "There is no precedent for a drug that didn't work in the population we studied working in other populations, in atrial fibrillation. The fact that this drug failed in this population, in my mind, makes it highly unlikely that you'll see efficacy in other groups." - Dr Peter R Kowey "There may be a lesson. . . . Maybe we have to test [supplements] just like we do drugs." - Dr Robert Califf *All comments from Omega-3 PUFA caps don't suppress paroxysmal AF in randomized trial (http://www.theheart.org/article/1148957.do)
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