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Ensayo controlado aleatorizado2005

Prevention of fatal arrhythmias in high-risk subjects by fish oil n-3 fatty acid intake

Leaf A, Albert CM, Josephson M, Steinhaus D, Kluger J, Kang JX, Cox B, Zhang H, Schoenfeld D, Fatty Acid Antiarrhythmia Trial Investigators

Circulation · 243 citas

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
Financiación independiente
Gobierno
National Heart, Lung, and Blood Institute
Gobierno
NHLBI NIH HHS
Subvenciones
National Heart, Lung, and Blood Institute (HL62154)

Según 2 financiadores declarados.

Publicación

Publicado
2005-11-01 · Circulation · vol. 112 · número 18 · págs. 2762–2768
Editorial
Lippincott Williams & Wilkins
Citado
364 citas · más que el 100% de estudios similares · 32.4× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
28 trabajos
Acceso
De pago
Áreas de investigación
Fatty Acid Research and Health · Cardiac electrophysiology and arrhythmias · Cardiac pacing and defibrillation studies
Palabras clave
fish oil, omega-3 fatty acids, ventricular arrhythmias, sudden cardiac death, implantable cardioverter-defibrillator, ventricular tachycardia, ventricular fibrillation, antiarrhythmic effect, high-risk patients, medication adherence
MeSH
humans, tachycardia, ventricular fibrillation, fatty acids, omega-3, fish oils, plant oils, survival analysis, double-blind method, defibrillators, implantable, dietary supplements, adult, middle aged, female, male, olive oil

9 autores

  • Alexander Leaf🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • Christine M. Albert🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • Mark E. Josephson🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • David M. Steinhaus🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • Jeffrey Kluger🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • Jing Xuan Kang🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • Benjamin Cox🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • Hui Zhang🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital
  • David Schoenfeld🇺🇸Brigham and Women's Hospital; Hartford Hospital; Beth Israel Deaconess Medical Center; Harvard University; Massachusetts General Hospital; Saint Luke's Hospital

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

The long-chain n-3 fatty acids in fish have been demonstrated to have antiarrhythmic properties in experimental models and to prevent sudden cardiac death in a randomized trial of post-myocardial infarction patients. Therefore, we hypothesized that these n-3 fatty acids might prevent potentially fatal ventricular arrhythmias in high-risk patients.

Methods and results

Four hundred two patients with implanted cardioverter/defibrillators (ICDs) were randomly assigned to double-blind treatment with either a fish oil or an olive oil daily supplement for 12 months. The primary end point, time to first ICD event for ventricular tachycardia or fibrillation (VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by intention to treat. Secondary analyses were performed for "probable" ventricular arrhythmias, "on-treatment" analyses for all subjects who had taken any of their oil supplements, and "on-treatment" analyses only of those subjects who were on treatment for at least 11 months. Compliance with double-blind treatment was similar in the 2 groups; however, the noncompliance rate was high (35% of all enrollees). In the primary analysis, assignment to treatment with the fish oil supplement showed a trend toward a prolonged time to the first ICD event (VT or VF) or of death from any cause (risk reduction of 28%; P=0.057). When therapies for probable episodes of VT or VF were included, the risk reduction became significant at 31%; P=0.033. For those who stayed on protocol for at least 11 months, the antiarrhythmic benefit of fish oil was improved for those with confirmed events (risk reduction of 38%; P=0.034).

Conclusions

Although significance was not achieved for the primary end point, this study provides evidence that for individuals at high risk of fatal ventricular arrhythmias, regular daily ingestion of fish oil fatty acids may significantly reduce potentially fatal ventricular arrhythmias.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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