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Are There Any Differences in the Efficacy and Safety of Different Formulations of Oral 5-ASA Used for Induction and Maintenance of Remission in Ulcerative Colitis? Evidence from Cochrane Reviews

Feagan, Brian G. MD*,†; Chande, Nilesh MD; MacDonald, John K. MA*,†

doi: 10.1097/MIB.0b013e3182920108
Cochrane Review Article

Background: We systematically reviewed and compared the efficacy and safety of oral mesalamine formulations (sustained release, delayed release, and prodrugs) used for induction and maintenance of remission in ulcerative colitis. The main objective of this review was to determine if there are any differences in efficacy or safety among the oral 5-ASA drugs.

Methods: A literature search in February 2013 identified all applicable randomized trials. Study quality was evaluated using the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation criteria were used to assess the overall quality of the evidence. Studies were subgrouped by common mesalamine comparators for meta-analysis. Studies were pooled for analysis if they compared equimolar doses of oral 5-ASA.

Results: Seventeen studies that evaluated 2925 patients were identified. The risk of bias was low for most factors, although 1 study was single blind and 3 were open label. No difference was observed between oral 5-ASA and comparator 5-ASA formulations in the proportion of patients with clinical remission (relative risk, 0.94; 95% confidence interval, 0.86–1.02), clinical improvement (relative risk, 0.89; 95% confidence interval, 0.77–1.01), or relapse at 12 months (relative risk, 1.01; 95% confidence interval, 0.80–1.28). Subgroup analyses showed no important differences in efficacy. No significant difference was demonstrated in rates of adverse events or withdrawal due to adverse events.

Conclusions: There does not seem to be any difference in efficacy or safety among the various formulations of oral 5-ASA. Oral mesalamine is an effective and safe treatment of mild-to-moderate or quiescent ulcerative colitis regardless of the chosen formulation.

Article first published online 27 June 2013

*Robarts Clinical Trials, Robarts Research Institute, London, Canada;

Department of Medicine, University of Western Ontario, London, Canada;

Department of Medicine, London Health Sciences Centre, Victoria Hospital, London, Canada.

Reprints: Brian G. Feagan, MD, Robarts Clinical Trials, Robarts Research Institute, Western University, PO Box 5015, 100 Perth Drive, London, Ontario, Canada N6A 5A5 (e-mail:

Funding for the IBD/FBD Review Group (September 1, 2010 to August 31, 2015) has been provided by the Canadian Institutes of Health Research Knowledge Translation Branch (CON—105529) and the Canadian Institutes of Health Research Institutes of Nutrition, Metabolism and Diabetes, and Infection and Immunity (III) and the Ontario Ministry of Health and Long-Term Care (HLTC3968FL—2010-2235).

The authors have no conflicts of interest to disclose.

Received March 03, 2013

Accepted March 13, 2013

© Crohn's & Colitis Foundation of America, Inc.
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