TY - JOUR
T1 - Omega-3 free fatty acids for the maintenance of remission in crohn disease
T2 - The EPIC randomized controlled trials
AU - Feagan, Brian G.
AU - Sandborn, William J.
AU - Mittmann, Ulrich
AU - Bar-Meir, Simon
AU - D'Haens, Geert
AU - Bradette, Marc
AU - Cohen, Albert
AU - Dallaire, Chrystian
AU - Ponich, Terry P.
AU - McDonald, John W.D.
AU - Hébuterne, Xavier
AU - Paré, Pierre
AU - Klvana, Pavel
AU - Niv, Yaron
AU - Ardizzone, Sandro
AU - Alexeeva, Olga
AU - Rostom, Alaa
AU - Kiudelis, Gediminas
AU - Spleiss, Johannes
AU - Gilgen, Denise
AU - Vandervoort, Margaret K.
AU - Wong, Cindy J.
AU - Guang, Yong Zou
AU - Donner, Allan
AU - Rutgeerts, Paul
PY - 2008/4/9
Y1 - 2008/4/9
N2 - 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:
AB - 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:
UR - http://www.scopus.com/inward/record.url?scp=41949118078&partnerID=8YFLogxK
U2 - 10.1001/jama.299.14.1690
DO - 10.1001/jama.299.14.1690
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C2 - 18398081
AN - SCOPUS:41949118078
SN - 0098-7484
VL - 299
SP - 1690
EP - 1697
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 14
ER -