Clinical—Alimentary TractDelayed-Release Oral Mesalamine 4.8 g/day (800-mg Tablet) Is Effective for Patients With Moderately Active Ulcerative Colitis
Section snippets
Patients
This multicenter, randomized, double-blind, double-dummy, active-controlled trial was conducted at 113 sites in 14 countries (Belarus, Canada, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russian Federation, Serbia and Montenegro, Ukraine, and United States [including Puerto Rico]) between July 2006 and June 2007. The Institutional Review Board or Ethics Committee at each site approved the protocol, and all patients gave written informed consent.
Criteria for
Characteristics and Disposition of the Patients
Seven-hundred and seventy-two patients were randomized to treatment and dosed (2.4 g/day, n = 383; 4.8 g/day, n = 389). A summary of patient disposition is provided in Figure 1. Baseline characteristics were similar in the 2 treatment groups (Table 1).
Efficacy
The primary objective of noninferiority was met. At week 6, 70.2% (273 of 389) of patients receiving delayed-release mesalamine 4.8 g/day (800-mg tablet) achieved treatment success at week 6, compared with 65.5% (251 of 383) of those who received
Discussion
Results of the ASCEND III trial show that delayed-release mesalamine 4.8 g/day (800-mg tablet) is safe and effective for the treatment of moderately active UC. Specifically, the trial demonstrated that 4.8 g/day (800-mg tablet) is noninferior to delayed-release mesalamine 2.4 g/day (400-mg tablet) for the endpoint of treatment success. Subgroup analyses demonstrated a generally consistent advantage in favor of the 4.8 g/day dose, with borderline significant or significant differences in
Acknowledgments
Editorial and writing support were provided by Judith M. Pepin, an employee of Procter & Gamble Pharmaceuticals. The ASCEND (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA) III Steering Committee of academic investigators (WJS, JR, BGF, EB, NJ, ML, SBH) were involved in the design and execution of the study; interpretation of results; and drafting and final approval of the manuscript. Procter & Gamble Pharmaceutical scientists (BY, PK, C-H Y, CAM) were involved with the
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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.