Comparison of efficacy of multimatrix mesalazine 4.8 g/ day once-daily with other high-dose mesalazine in active ulcerative colitis: A randomized, double-blind study

Haruhiko Ogata, Nobuo Aoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi

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Abstract

Background/Aims: This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) compared to another form of high-dose mesalazine. Methods: In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependentrelease mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI) at the end of the treatment period. Results: The change in the UC-DAI (mean±standard deviation) in the perprotocol set was -2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and -1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was -0.7 (two-sided 95% confidence interval, -1.3 to -0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/ day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependentrelease mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups. Conclusions: Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.

Original languageEnglish
Pages (from-to)368-379
Number of pages12
JournalIntestinal Research
Volume15
Issue number3
DOIs
Publication statusPublished - 2017

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Mesalamine
Ulcerative Colitis
Double-Blind Method
Safety

Keywords

  • High-dose
  • Mesalazine
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

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Comparison of efficacy of multimatrix mesalazine 4.8 g/ day once-daily with other high-dose mesalazine in active ulcerative colitis : A randomized, double-blind study. / Ogata, Haruhiko; Aoyama, Nobuo; Mizushima, Seiichi; Hagino, Atsushi; Hibi, Toshifumi.

In: Intestinal Research, Vol. 15, No. 3, 2017, p. 368-379.

Research output: Contribution to journalArticle

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abstract = "Background/Aims: This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) compared to another form of high-dose mesalazine. Methods: In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependentrelease mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI) at the end of the treatment period. Results: The change in the UC-DAI (mean±standard deviation) in the perprotocol set was -2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and -1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was -0.7 (two-sided 95{\%} confidence interval, -1.3 to -0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/ day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependentrelease mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups. Conclusions: Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.",
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AU - Hagino, Atsushi

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