Financiado en parte por Sigma-Tau Pharmaceuticals, Sigma Tau, SPA Società Prodotti Antibiotici
Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: results of the FORWARD (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation) trial
Macchia A, Grancelli H, Varini S, Nul D, Laffaye N, Mariani J, Ferrante D, Badra R, Figal J, Ramos S, Tognoni G, Doval HC, GESICA Investigators
Journal of the American College of Cardiology · 101 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
- Sigma-Tau Pharmaceuticals
- Empresa
- Sigma Tau
- Empresa
- SPA Società Prodotti Antibiotici
Según 3 financiadores declarados.
Publicación
- Publicado
- 2012-12-19 · J Am Coll Cardiol · vol. 61 · número 4 · págs. 463–468
- Editorial
- Elsevier BV
- Citado
- 138 citas · más que el 98% de estudios similares · 8.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 14 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Atrial Fibrillation Management and Outcomes · Fatty Acid Research and Health · Cardiac Health and Mental Health
- Palabras clave
- omega-3 fatty acids, atrial fibrillation recurrence, atrial fibrillation prevention, sinus rhythm maintenance, cardioversion, dietary supplementation, bleeding events, stroke, myocardial infarction, heart failure
- MeSH
- humans, atrial fibrillation, fatty acids, omega-3, anti-arrhythmia agents, heart function tests, electrocardiography, treatment outcome, electric countershock, hospitalization, endpoint determination, survival rate, double-blind method, dietary supplements, aged, middle aged, female, male, stroke, secondary prevention
12 autores
- Alejandro Macchia🇦🇷Fundación GESICA
- Hugo Grancelli🇦🇷Fundación GESICA
- Sergio D. Varini🇦🇷Fundación GESICA
- Daniel R. Nul🇦🇷Fundación GESICA
- Nicolás Laffaye🇦🇷Fundación GESICA
- Javier A. Mariani🇦🇷Fundación GESICA
- Daniel Ferrante🇦🇷Fundación GESICA
- Raúl Badra🇦🇷Hospital Privado de Comunidad
- Julio César Figal🇦🇷Favaloro Foundation
- Silvina Ramos
- Gianni Tognoni🇮🇹Mario Negri Sud Foundation
- Hernán C. Doval🇦🇷Fundación GESICA
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objectives
The aim of this study was to evaluate the efficacy of polyunsaturated fatty acids (n-3 PUFA) for the prevention of recurrent atrial fibrillation (AF) in patients with normal sinus rhythm.
Background
Current pharmacological treatments to limit recurrent AF in patients with previous AF have limited efficacy and high rates of adverse events. Results of trials that tested the efficacy of n-3 PUFA provided heterogeneous results.
Methods
This was a prospective, randomized, double-blind, placebo-controlled, multicenter trial involving 586 outpatient participants with confirmed symptomatic paroxysmal AF that required cardioversion (n = 428), at least 2 episodes of AF in the 6 months before randomization (n = 55), or both (103). Patients were randomly allocated to n-3 PUFA (1 g/day) or placebo for 12 months. The primary endpoint was symptomatic recurrence of AF.
Results
There were no significant differences between patients allocated to placebo and those who received n-3 PUFA for the main outcome. At 12 months, 56 of 297 participants (18.9%) in the placebo group and 69 of 289 participants (24.0%) in the n-3 PUFA group had a recurrent symptomatic AF (hazard ratio: 1.28, 95% confidence interval: 0.90 to 1.83, p = 0.17). There was no difference between treatment with placebo and n-3 PUFA for any of the other pre-specified endpoints, including the composite of all-cause mortality, nonfatal stroke, nonfatal acute myocardial infarction, systemic embolism, heart failure development, or severe bleeding that occurred in 20 (6.7%) and 16 (5.5%) of patients randomized to placebo or n-3 PUFA, respectively (hazard ratio: 0.86, 95% confidence interval: 0.44 to 1.66, p = 0.65).
Conclusions
Pharmacological supplementation with 1 g of n-3 PUFA for 1 year did not reduce recurrent AF. (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation [FORWARD]; NCT00597220).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.