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

• Published in: Intestinal Research Vol. 15; no. 3; pp. 358 - 367
• Main Authors: Ogata, Haruhiko, Ohori, Akihiro, Nishino, Haruo, Mizushima, Seiichi, Hagino, Atsushi, Hibi, Toshifumi
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Association for the Study of Intestinal Diseases 01.07.2017; 대한장연구학회
• Subjects: Colitis, ulcerative; Maintenance; Mesalazine; Once-daily; Original; 내과학; Once-daily; Maintenance; Mesalazine; Colitis, ulcerative
• ISSN: 1598-9100; 2288-1956
• DOI: 10.5217/ir.2017.15.3.358

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. 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. 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. 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.