Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials
Feagan BG, Sandborn WJ, Mittmann U, Bar-Meir S, D'Haens G, Bradette M, Cohen A, Dallaire C, Ponich TP, McDonald JW, Hébuterne X, Paré P, Klvana P, Niv Y, Ardizzone S, Alexeeva O, Rostom A, Kiudelis G, Spleiss J, Gilgen D, Vandervoort MK, Wong CJ, Zou GY, Donner A, Rutgeerts P
JAMA · 179 citas
Etiquetas de revisión
Financiación no declaradaDatos 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
- Financiación no declarada
Publicación
- Publicado
- 2008-04-08 · JAMA · vol. 299 · número 14 · pág. 1690
- Editorial
- American Medical Association
- Citado
- 276 citas · más que el 99% de estudios similares · 10.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 39 trabajos
- Acceso
- De pago
- Áreas de investigación
- Inflammatory Bowel Disease · Fatty Acid Research and Health · Rheumatoid Arthritis Research and Therapies
- Palabras clave
- Crohn's disease, omega-3 fatty acids, maintenance therapy, relapse prevention, quiescent disease, CDAI, immunosuppressants, infection risk, adverse events, dietary supplementation, omega-3 polyunsaturated fatty acids, omega-6 fatty acids, n-6/n-3 ratio
- MeSH
- humans, crohn disease, fatty acids, omega-3, glucocorticoids, remission induction, double-blind method, adult, middle aged, female, male, secondary prevention
25 autores
- Brian G. Feagan🇨🇦 · autor de correspondenciaWestern University; Robarts Clinical Trials; Robarts Research Institute
- William J. Sandborn
- Ulrich Mittmann
- Simon Bar–Meir
- Geert D’Haens
- Marc Bradette
- Albert Cohen
- Chrystian Dallaire
- Terry P. Ponich
- John WD McDonald
- Xavier Hébuterne
- Pierre Paré
- Pavel Klvaňa
- Yaron Niv
- Sandro Ardizzone
- Olga Alexeeva
- Alaa Rostom
- Gediminas Kiudelis
- Johannes Spleiss
- Denise Gilgen
- Margaret K. Vandervoort
- Cindy J. Wong
- Guangyong Zou
- ALLAN P. DONNER
- Paul J. Rutgeerts
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Maintenance therapy for Crohn disease features the use of immunosuppressive drugs, which are associated with an increased risk of infection. Identification of safe and effective maintenance strategies is a priority.
Objective
To determine whether the oral administration of omega-3 free fatty acids is more effective than placebo for prevention of relapse of Crohn disease.
Design, setting, and patients
Two randomized, double-blind, placebo-controlled studies (Epanova Program in Crohn's Study 1 [EPIC-1] and EPIC-2) conducted between January 2003 and February 2007 at 98 centers in Canada, Europe, Israel, and the United States. Data from 363 and 375 patients with quiescent Crohn disease were evaluated in EPIC-1 and EPIC-2, respectively.
Interventions
Patients with a Crohn's Disease Activity Index (CDAI) score of less than 150 were randomly assigned to receive either 4 g/d of omega-3 free fatty acids or placebo for up to 58 weeks. No other treatments for Crohn disease were permitted.
Main outcome measure
Clinical relapse, as defined by a CDAI score of 150 points or greater and an increase of more than 70 points from the baseline value, or initiation of treatment for active Crohn disease.
Results
For EPIC-1, 188 patients were assigned to receive omega-3 free fatty acids and 186 patients to receive placebo. Corresponding numbers for EPIC-2 were 189 and 190 patients, respectively. The rate of relapse at 1 year in EPIC-1 was 31.6% in patients who received omega-3 free fatty acids and 35.7% in those who received placebo (hazard ratio, 0.82; 95% confidence interval, 0.51-1.19; P = .30). Corresponding values for EPIC-2 were 47.8% and 48.8% (hazard ratio, 0.90; 95% confidence interval, 0.67-1.21; P = .48). Serious adverse events were uncommon and mostly related to Crohn disease.
Conclusion
In these trials, treatment with omega-3 free fatty acids was not effective for the prevention of relapse in Crohn disease.
Trial registration
clinicaltrials.gov Identifiers: EPIC-1: NCT00613197, EPIC-2: NCT00074542.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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