Intest Res.  2016 Jan;14(1):50-59. 10.5217/ir.2016.14.1.50.

Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study

Affiliations
  • 1Department of Internal Medicine, Toho University Sakura Medical Center, Chiba, Japan.
  • 2Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
  • 3Kinshukai Infusion Clinic, Osaka, Japan.
  • 4Zeria Pharmaceutical Co., Ltd., Tokyo, Japan.
  • 5Kitasato Institute Hospital, Kitasato University, Tokyo, Japan. thibi@insti.kitasato-u.ac.jp

Abstract

BACKGROUND/AIMS
The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC).
METHODS
In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates.
RESULTS
In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups.
CONCLUSIONS
The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.

Keyword

Asacol; pH-dependent-release mesalamine; Colitis, ulcerative; Double-blind method

MeSH Terms

Colitis, Ulcerative*
Consensus
Double-Blind Method
Humans
Mesalamine*
Remission Induction
Ulcer*
Mesalamine
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