Intestinal Research 2017; 15(3): 358-367  http://dx.doi.org/10.5217/ir.2017.15.3.358
Comparison of efficacies of once-daily dose multimatrix mesalazine and multiple-dose mesalazine for the maintenance of remission in ulcerative colitis: a randomized, double-blind study
Haruhiko Ogata1, Akihiro Ohori2, Haruo Nishino3, Seiichi Mizushima4, Atsushi Hagino4, Toshifumi Hibi5
1Center for Diagnostic and Therapeutic Endoscopy, Keio University Hospital, Tokyo, 2Inogashiradori Proctology and Gastroenterology Clinic, Tokyo, 3Matsushima Clinic, Kanagawa, 4Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, 5Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan
Correspondence to: Haruhiko Ogata, Center for Diagnostic and Therapeutic Endoscopy, Keio University Hospital, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.  Tel: +81-3-3353-1211, Fax: +81-3-3353-3536, E-mail: hogata@z8.keio.jp
Received: October 10, 2016; Revised: December 13, 2016; Accepted: December 31, 2016; Published online: February 22, 2017.
© Korean Association for the Study of Intestinal Diseases. All rights reserved.

Abstract
Background/Aims: This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission. Methods: In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding. Results: The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, −3.9% to 17.6%). The noninferiority margin of −10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety. Conclusions: A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis. (Intest Res 2017;15:358-367)
Keywords: Colitis, ulcerative; Mesalazine; Maintenance; Once-daily


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