The DOI matches its Crossref record; 39 of the 39 references it cites were found in a registry or an index.
Omega-3 Free Fatty Acids for the Maintenance of Remission in Crohn Disease: The EPIC Randomized Controlled Trials
Abstract
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.
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Cites
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Self-citationTuberculosis Associated with Infliximab, a Tumor Necrosis Factor α–Neutralizing Agent
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Cited by
Lamb, C. A., Kennedy, N. A., Raine, T., Hendy, P. A., Smith, P. J., Limdi, J. K., Hayee, B., Lomer, M. C. E., Parkes, G. C., Selinger, C., et al. (2019) · Gut · doi:10.1136/gutjnl-2019-318484 · Cited by 2,346
Marine omega-3 fatty acids and inflammatory processes: effects, mechanisms and clinical relevance
Calder, P. C. (2015) · Biochimica et Biophysica Acta (BBA) - Molecular and Cell Biology of Lipids · doi:10.1016/j.bbalip.2014.08.010 · Cited by 1,717
Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn’s disease
Ruemmele, F. M., Veres, G., Kolho, K. L., Griffiths, A., Levine, A., Escher, J. C., Amil Dias, J., Barabino, A., Braegger, C. P., Bronsky, J., et al. (2014) · Journal of Crohn s and Colitis · doi:10.1016/j.crohns.2014.04.005 · Cited by 1,083
Van Assche, G., Dignass, A., Reinisch, W., van der Woude, C. J., Sturm, A., De Vos, M., Guslandi, M., Oldenburg, B., Dotan, I., Marteau, P., et al. (2010) · Journal of Crohn's and Colitis · doi:10.1016/j.crohns.2009.09.009 · Cited by 894
Self-citationESPEN guideline: Clinical nutrition in inflammatory bowel disease
Forbes, A., Escher, J., Hébuterne, X., Kłęk, S., Krznaric, Z., Schneider, S., Shamir, R., Stardelova, K., Wierdsma, N., Wiskin, A. E., et al. (2017) · Clinical Nutrition · doi:10.1016/j.clnu.2016.12.027 · Cited by 625
Self-citationRetracted
Metadata
- Authors
- Feagan, B. G., Sandborn, W. J., Mittmann, U., Bar-Meir, S., D’Haens, G., Bradette, M., Cohen, A., Dallaire, C., Ponich, T. P., McDonald, J. W. D., Hébuterne, X., Paré, P., Klvana, P., Niv, Y., Ardizzone, S., Alexeeva, O., Rostom, A., Kiudelis, G., Spleiss, J., Gilgen, D., Vandervoort, M. K., Wong, C. J., Zou, G. Y., Donner, A., & Rutgeerts, P.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2008-04-09
- Volume
- 299
- Issue
- 14
- Pages
- 1690
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W1996078707
- Cited by
- 275
- References
- 39
- FWCI
- 10.37
- Type
- journal article
- Language
- en
- Open access
- closed
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- Feagan, B. G., Sandborn, W. J., Mittmann, U., Bar-Meir, S., D’Haens, G., Bradette, M., Cohen, A., Dallaire, C., Ponich, T. P., McDonald, J. W. D., Hébuterne, X., Paré, P., Klvana, P., Niv, Y., Ardizzone, S., Alexeeva, O., Rostom, A., Kiudelis, G., Spleiss, J., . . . Rutgeerts, P. (2008). Omega-3 Free Fatty Acids for the Maintenance of Remission in Crohn Disease: The EPIC Randomized Controlled Trials. JAMA. https://doi.org/10.1001/jama.299.14.1690
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