Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis: a double-blind, randomized study

  • Ito H
  • Iida M
  • Matsumoto T
 et al. 
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Abstract

BACKGROUND: Mesalamine is the first-line drug for the treatment of ulcerative colitis (UC). We directly compared the efficacy and safety of two mesalamine formulations for the induction of remission in patients with UC. METHODS: In a multicenter, double-blind, randomized study, 229 patients with mild-to-moderate active UC were assigned to 4 groups: 66 and 65 received a pH-dependent release formulation of 2.4 g/day (pH-2.4 g) or 3.6 g/day (pH-3.6 g), respectively; 65 received a time-dependent release formulation of 2.25 g/day (Time-2.25 g), and 33 received placebo (Placebo). The drugs were administered three times daily for eight weeks. The primary endpoint was a decrease in the UC disease activity index (UC-DAI). RESULTS: In the full analysis set (n = 225) the decrease in UC-DAI in each group was 1.5 in pH-2.4 g, 2.9 in pH-3.6 g, 1.3 in Time-2.25 g and 0.3 in Placebo, respectively. These results demonstrate the superiority of pH-3.6 g over Time-2.25 g (P = 0.003) and the noninferiority of pH-2.4 g to Time-2.25 g. Among the patients with proctitis-type UC, a significant decrease in UC-DAI was observed in pH-2.4 g and pH-3.6 g as compared to Placebo, but not in Time-2.25 g. No differences were observed in the safety profiles. CONCLUSIONS: Higher dose of the pH-dependent release formulation was more effective for induction of remission in patients with mild-to-moderate active UC. Additionally, the pH-dependent release formulation was preferable to the time-dependent release formulation for patients with proctitis-type UC (UMIN Clinical Trials Registry, no. C000000288).

Author-supplied keywords

  • Adolescent
  • Adult[checkword]
  • Aged[checkword]
  • Anti-Inflammatory Agents
  • Chemistry
  • Colitis
  • Double-Blind Method
  • Female[checkword]
  • Follow-Up Studies
  • Hs-ibd: sr-ibd: hs-handsrch
  • Humans[checkword]
  • Hydrogen-Ion Concentration
  • Male[checkword]
  • Mesalamine [chemistry] [therapeutic use]
  • Middle Aged[checkword]
  • Non-Steroidal [chemistry
  • Non-Steroidal [chemistry] [therapeutic use]
  • Pharmaceutical
  • Pharmaceutical Preparations [administration & dosa
  • Remission Induction
  • Severity of Illness Index
  • Sr-ibd
  • Survival Rate
  • Time Factors
  • Treatment Outcome
  • Ulcerative [drug therapy] [pathology]
  • Young Adult[checkword]

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Authors

  • H Ito

  • M Iida

  • T Matsumoto

  • Y Suzuki

  • Y Aida

  • T Yoshida

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