Omega-3 free fatty acids for the maintenance of remission in Crohn disease: the EPIC Randomized Controlled Trials.
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.
Feagan
Brian G
BG
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, 100 Perth Dr, London, ON, Canada N6A 5K8. bfeagan@robarts.ca
Sandborn
William J
WJ
Mittmann
Ulrich
U
Bar-Meir
Simon
S
D'Haens
Geert
G
Bradette
Marc
M
Cohen
Albert
A
Dallaire
Chrystian
C
Ponich
Terry P
TP
McDonald
John W D
JW
Hébuterne
Xavier
X
Paré
Pierre
P
Klvana
Pavel
P
Niv
Yaron
Y
Ardizzone
Sandro
S
Alexeeva
Olga
O
Rostom
Alaa
A
Kiudelis
Gediminas
G
Spleiss
Johannes
J
Gilgen
Denise
D
Vandervoort
Margaret K
MK
Wong
Cindy J
CJ
Zou
Guang Yong
GY
Donner
Allan
A
Rutgeerts
Paul
P
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
D015525:Fatty Acids, Omega-3; D005938:Glucocorticoids