Delayed-Release Oral Mesalamine 4.8 g/day (800-mg Tablet) Is Effective for Patients With Moderately Active Ulcerative Colitis
Background and Aims
It is not clear what induction dose of mesalamine is optimal for treating patients with mildly and moderately active ulcerative colitis (UC). This study was conducted to determine the efficacy and safety of mesalamine 4.8 g/day compared with 2.4 g/day for the treatment of moderately active UC.
Methods
A multicenter, randomized, double-blind, 6-week, active-control study (ASCEND III) was conducted to assess the noninferiority of delayed-release mesalamine 4.8 g/day (Asacol HD, 800-mg tablet; Procter & Gamble, Pharmaceuticals, Inc, Mason, Ohio) with 2.4 g/day (Asacol, 400-mg tablet; Procter & Gamble Pharmaceuticals, Inc) in 772 patients with moderately active UC. The primary endpoint was treatment success (overall improvement) at week 6, defined as improvement in the Physician's Global Assessment (based on clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy), with no worsening in any individual clinical assessment.
Results
The primary objective of noninferiority was met. Seventy percent (273 of 389) of patients who received 4.8 g/day of mesalamine achieved treatment success at week 6, compared with 66% (251 of 383) of patients receiving 2.4 g/day (95% confidence interval for 2.4 g/day minus 4.8 g/day, −11.2 to 1.9). In addition, 43% of patients who received 4.8 g/day mesalamine achieved clinical remission at week 6 compared with 35% of patients who received 2.4 g/day (P = .04). A therapeutic advantage for the 4.8 g/day dose was observed among patients previously treated with corticosteroids, oral mesalamines, rectal therapies, or multiple UC medications. Both regimens were well-tolerated with similar adverse events.
Conclusions
Delayed-release mesalamine 4.8 g/day (800-mg tablet) is efficacious and well-tolerated in patients with moderately active UC.
Abbreviations used in this paper: AE, adverse event, CFT, contact friability test, ITT, intent-to-treat, PFA, Patient's Functional Assessment, PGA, Physician's Global Assessment, UC, ulcerative colitis, UCDAI, xxx
This article has an accompanying continuing medical education activity on page 2158. Learning Objective: Upon completion of reading this article, successful learners will be able to apply the results of the study to their practice by weighing the potential benefits of mesalamine dosed at 2.4 or 4.8 g/d in individual patients with moderate ulcerative colitis.
Conflicts of interest The authors disclose the following: Dr Sandborn has served as a consultant for and received research funding from Procter & Gamble Pharmaceuticals and Shire Pharmaceuticals, and has served as a consultant for Salix Pharmaceuticals. Dr Regula has obtained lecture fees from Abbott and Schering Plough. Dr Feagan has received honorariums from Procter & Gamble Pharmaceuticals. Dr Yacyshyn was previously employed by Procter & Gamble Pharmaceuticals. Drs Krzeski, Yeh, and Messer are employees of Procter & Gamble Pharmaceuticals. Dr Hanauer has served as a consultant for and received clinical research support from Procter & Gamble Pharmaceuticals and has served as a consultant to Shire Pharmaceuticals, Ferring Pharmaceuticals, and Salix Pharmaceuticals. The remaining authors disclose no conflicts.
Funding This study was funded by Procter & Gamble Pharmaceuticals, Inc, Mason, Ohio.
PII: S0016-5085(09)01570-4
doi:10.1053/j.gastro.2009.08.069
© 2009 AGA Institute. Published by Elsevier Inc. All rights reserved.
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