title: Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  In these trials, treatment with omega-3 free fatty acids was not effective for the prevention of relapse in Crohn disease.
  
  
  BACKGROUND
  clinicaltrials.gov Identifiers: EPIC-1: NCT00613197, EPIC-2: NCT00074542.
authors.affiliation: Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, 100 Perth Dr, London, ON, Canada N6A 5K8. bfeagan@robarts.ca
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Ulrich
authors.initials: U
authors.lastname: Mittmann
authors.forename: Simon
authors.initials: S
authors.lastname: Bar-Meir
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.forename: Marc
authors.initials: M
authors.lastname: Bradette
authors.forename: Albert
authors.initials: A
authors.lastname: Cohen
authors.forename: Chrystian
authors.initials: C
authors.lastname: Dallaire
authors.forename: Terry P
authors.initials: TP
authors.lastname: Ponich
authors.forename: John W D
authors.initials: JW
authors.lastname: McDonald
authors.forename: Xavier
authors.initials: X
authors.lastname: Hébuterne
authors.forename: Pierre
authors.initials: P
authors.lastname: Paré
authors.forename: Pavel
authors.initials: P
authors.lastname: Klvana
authors.forename: Yaron
authors.initials: Y
authors.lastname: Niv
authors.forename: Sandro
authors.initials: S
authors.lastname: Ardizzone
authors.forename: Olga
authors.initials: O
authors.lastname: Alexeeva
authors.forename: Alaa
authors.initials: A
authors.lastname: Rostom
authors.forename: Gediminas
authors.initials: G
authors.lastname: Kiudelis
authors.forename: Johannes
authors.initials: J
authors.lastname: Spleiss
authors.forename: Denise
authors.initials: D
authors.lastname: Gilgen
authors.forename: Margaret K
authors.initials: MK
authors.lastname: Vandervoort
authors.forename: Cindy J
authors.initials: CJ
authors.lastname: Wong
authors.forename: Guang Yong
authors.initials: GY
authors.lastname: Zou
authors.forename: Allan
authors.initials: A
authors.lastname: Donner
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
mesh_terms: D000328:Adult; D003424:Crohn Disease / Q000503:physiopathology / Q000517:prevention & control*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D055502:Secondary Prevention
chemical_list: D015525:Fatty Acids, Omega-3; D005938:Glucocorticoids