From Fish Oil to Snake Oil: Glaxo Fish Oil Pill Bombs In Heart Rhythm Study
From Fish Oil to Snake Oil: Glaxo Fish Oil Pill Bombs In Heart Rhythm Study - Robert Langreth - Treatments - Forbes
Huge numbers of patients around the world take fish oil pills in hopes of preventing common heart rhythm problems.
But now a giant trial shows that GlaxoSmithkline’s expensive prescription fish oil pill Lovaza did nothing to prevent symptoms of atrial fibrillation, one of the most common heart rhythm problems, in the largest trial of its type ever done. The results are a blow to GlaxoSmithkline, which sponsored the trial, and could drive down sales.
The 663 patient trial compared patients with a type of atrial fibrillation called paroxysmal AF, giving half the fish oil pill and half a placebo. It sought to see if the fish oil would prevent the next occurrence of symptoms. There was no hint that it did on any measure. The paper is being published in the Journal of the American Medical Association.
“We demonstrated incontrovertibly that patients who received this drug did no better than patients who received placebo,” said Peter Kowey of the Lankenau Institute for Medical Research, who led the trial. “The fact that this drug failed in this population makes it highly unlikely we would find efficacy in other groups with atrial fibrillation.”
“We don’t have any evidence that taking omega-3 fatty acids prevent symptoms in AF patients,” said Harvard Medical School’s Christine Albert, who discussed the results at a press conference at the American Heart Association meeting.
There were even some small hints that the fish oil could make it worse, although this may simply have been the play of chance. The results did not address whether the drug helps in other heart rhythm disorder.
There are no rigorous clinical trials showing that omega-three fatty acids in fish oil help prevent heart disease in healthy patients, although many epidemiology studies hint that this may be the case, Dr. Albert said. “There really have been no primary prevention trials,there have been none,” she said. She said that a big government trial is ongoing that could resolve the matter.
“It may be a lesson of all this food supplement stuff that we need to test them like drugs,” said Robert Califf of Duke University.
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:jama.2010.1735. JAMA -- Efficacy and Safety of Prescription Omega-3 Fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation: A Randomized Controlled Trial, November 15, 2010, Kowey et al. 0 (2010): jama.2010.1735v1
Context 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.
Design, Setting, and Participants 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).
Interventions 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.
Main Outcome Measures 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
, 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.
Conclusion Among participants with paroxysmal AF, 24-week treatment with prescription omega-3 compared with placebo did not reduce recurrent AF over 6 months.
Trial Registration clinicaltrials.gov Identifier: NCT00402363
From Fish Oil to Snake Oil: Glaxo Fish Oil Pill Bombs In Heart Rhythm Study - Robert Langreth - Treatments - Forbes
Huge numbers of patients around the world take fish oil pills in hopes of preventing common heart rhythm problems.
But now a giant trial shows that GlaxoSmithkline’s expensive prescription fish oil pill Lovaza did nothing to prevent symptoms of atrial fibrillation, one of the most common heart rhythm problems, in the largest trial of its type ever done. The results are a blow to GlaxoSmithkline, which sponsored the trial, and could drive down sales.
The 663 patient trial compared patients with a type of atrial fibrillation called paroxysmal AF, giving half the fish oil pill and half a placebo. It sought to see if the fish oil would prevent the next occurrence of symptoms. There was no hint that it did on any measure. The paper is being published in the Journal of the American Medical Association.
“We demonstrated incontrovertibly that patients who received this drug did no better than patients who received placebo,” said Peter Kowey of the Lankenau Institute for Medical Research, who led the trial. “The fact that this drug failed in this population makes it highly unlikely we would find efficacy in other groups with atrial fibrillation.”
“We don’t have any evidence that taking omega-3 fatty acids prevent symptoms in AF patients,” said Harvard Medical School’s Christine Albert, who discussed the results at a press conference at the American Heart Association meeting.
There were even some small hints that the fish oil could make it worse, although this may simply have been the play of chance. The results did not address whether the drug helps in other heart rhythm disorder.
There are no rigorous clinical trials showing that omega-three fatty acids in fish oil help prevent heart disease in healthy patients, although many epidemiology studies hint that this may be the case, Dr. Albert said. “There really have been no primary prevention trials,there have been none,” she said. She said that a big government trial is ongoing that could resolve the matter.
“It may be a lesson of all this food supplement stuff that we need to test them like drugs,” said Robert Califf of Duke University.
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:jama.2010.1735. JAMA -- Efficacy and Safety of Prescription Omega-3 Fatty Acids for the Prevention of Recurrent Symptomatic Atrial Fibrillation: A Randomized Controlled Trial, November 15, 2010, Kowey et al. 0 (2010): jama.2010.1735v1
Context 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.
Design, Setting, and Participants 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).
Interventions 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.
Main Outcome Measures 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
, 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.
Conclusion Among participants with paroxysmal AF, 24-week treatment with prescription omega-3 compared with placebo did not reduce recurrent AF over 6 months.
Trial Registration clinicaltrials.gov Identifier: NCT00402363
