title: Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Internal Medicine, Toho University Sakura Medical Center, Chiba, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
authors.affiliation: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Iida
authors.affiliation: Kinshukai Infusion Clinic, Osaka, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ito
authors.affiliation: Zeria Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Isamu
authors.initials: I
authors.lastname: Saida
authors.affiliation: Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
keywords: Asacol; Colitis, ulcerative; Double-blind method; pH-dependent-release mesalamine