Open AccessDirect comparison of two different mesalamine formulations for the maintenance of remission in patients with ulcerative colitis: A double‐blind, randomized study
Author(s) -
Ito Hiroaki,
Iida Mitsuo,
Matsumoto Takayuki,
Suzuki Yasuo,
Aida Yoshiyuki,
Yoshida Toyomitsu,
Takano Yuichi,
Hibi Toshifumi
Publication year - 2010
Publication title -
inflammatory bowel diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.932
H-Index - 146
eISSN - 1536-4844
pISSN - 1078-0998
DOI - 10.1002/ibd.21194
Subject(s) - ulcerative colitis , bloody , medicine , gastroenterology , clinical endpoint , colitis , randomized controlled trial , double blind , surgery , disease , alternative medicine , pathology , placebo
Background: Mesalamine has been used as the first‐line medication for the treatment of ulcerative colitis (UC). We directly compared the efficacy and safety of two different mesalamine formulations in the maintenance of remission in patients with UC. Methods: In a multicenter, double‐blind, randomized study, 131 patients with quiescent UC were assigned to two groups: 65 to receive a pH‐dependent release formulation of mesalamine at 2.4 g/day (pH‐2.4 g) and 66 to receive a time‐dependent release formulation of mesalamine at 2.25 g/day (Time‐2.25 g). Both formulations were administered three times daily for 48 weeks. The primary endpoint was the proportion of patients without bloody stools. Results: In the full analysis set ( n = 130), the proportion of patients without bloody stools was 76.9% in the pH‐2.4 g and 69.2% in the Time‐2.25 g, demonstrating the noninferiority of pH‐2.4 g to Time‐2.25 g. No statistically significant difference in time to bloody stools was found between the two formulations ( P = 0.27, log‐rank test), but the time to bloody stools tended to be longer in pH‐2.4 g compared to Time‐2.25 g, and a similar trend was observed with regard to the time to relapse. No differences were observed between the safety profiles of the two formulations. Conclusions: The pH‐ and time‐dependent release of mesalamine formulations were similarly safe and effective. Interestingly, the remission phase tended to be longer in the group that received the pH‐dependent formulation compared to the group that received the time‐dependent formulation (UMIN Clinical Trials Registry, no. C289). (Inflamm Bowel Dis 2010)