Financiado en parte por Bristol-Myers Squibb, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Gilead Sciences, Boston Scientific Corporation, Daiichi-Sankyo, Astellas Pharma, Biosense Webster
Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial
Kowey PR, Reiffel JA, Ellenbogen KA, Naccarelli GV, Pratt CM
JAMA · 146 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Bristol-Myers Squibb
- Empresa
- Pfizer
- Empresa
- AstraZeneca
- Empresa
- GlaxoSmithKline
- Empresa
- Sanofi
- Empresa
- Gilead Sciences
- Universidad u hospital
- Dartmouth College
- Empresa
- Boston Scientific Corporation
- Empresa
- Daiichi-Sankyo
- Empresa
- Astellas Pharma
- Empresa
- Biosense Webster
Según 11 financiadores declarados.
Publicación
- Publicado
- 2010-11-16 · JAMA · vol. 304 · número 21 · pág. 2363
- Editorial
- American Medical Association
- Citado
- 201 citas · más que el 100% de estudios similares · 23.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 24 trabajos
- Acceso
- De pago
- Áreas de investigación
- Atrial Fibrillation Management and Outcomes · Fatty Acid Research and Health · Cardiac Health and Mental Health
- Palabras clave
- atrial fibrillation, omega-3 fatty acids, atrial fibrillation recurrence, paroxysmal atrial fibrillation, persistent atrial fibrillation, antiarrhythmic therapy, efficacy, omega-3 polyunsaturated fatty acids, atrial flutter, sinus rhythm maintenance, structural heart disease, adverse events, vitamin K
- MeSH
- humans, atrial fibrillation, recurrence, fatty acids, omega-3, treatment outcome, prospective studies, double-blind method, aged, middle aged, female, male
5 autores
- Peter Russell Kowey🇺🇸Main Line Health; Lankenau Institute for Medical Research
- James A. Reiffel🇺🇸Columbia University Irving Medical Center
- Kenneth A. Ellenbogen🇺🇸Virginia Commonwealth University Medical Center
- Gerald V. Naccarelli🇺🇸Pennsylvania State University
- Craig M. Pratt
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 [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.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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