Hiroaki Ito, M. Iida, T. Matsumoto
Jan 4, 2010
Citations
4
Influential Citations
67
Citations
Quality indicators
Journal
Inflammatory Bowel Diseases
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). (Inflamm Bowel Dis 2010)