Published in:
01-03-2016 | Original Research
Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study
Published in: Advances in Therapy | Issue 3/2016
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Introduction
This study aimed to compare the efficacy and safety of two mesalazine formulations in the treatment of Chinese patients with ulcerative colitis (UC) in the remission phase.
Methods
In this multicenter, single-blind, randomized controlled study conducted from November 2010 to August 2012, 251 patients with UC from 18 hospitals were enrolled. The patients were randomized to treatment with mesalazine modified-release tablets (MR group, n = 126) or other enteric-coated tablets (EC group, n = 125), at 800 mg three-times daily for 48 weeks. The primary efficacy parameter was the rate of non-emergence of bloody stool. If the lower limit of the 95% confidence interval (CI) of the primary efficacy measure was over −10%, the modified-release tablets were considered non-inferior to the enteric-coated tablets. The secondary efficacy parameters included the period of non-emergence of bloody stool and the period of non-recurrence of UC. The incidences of adverse events and adverse drug reactions were compared between the two groups.
Results
At 48 weeks of maintenance treatment, the rates of non-emergence of bloody stool were 82.99% (95% CI 73.53–92.45%) and 73.30% (95% CI 64.04–82.56%) in the MR and EC groups, respectively, and the difference between the two groups was 9.69% (95% CI −1.15–20.53%). There was no significant difference in the period of non-emergence of bloody stool and the period of non-recurrence of UC between the two groups (P > 0.05). The incidences of adverse events were 48.78% (60/123) and 48.00% (60/125) in the MR and EC groups, respectively (P = 0.902). The incidences of adverse drug reactions were 16.26% (20/123) and 13.60% (17/125) in the MR and EC groups, respectively (P = 0.556).
Conclusion
Mesalazine modified-release tablets were non-inferior to the enteric-coated tablets and may be considered an effective and safe treatment alternative for the maintenance of remission in Chinese patients with UC.
Trial registration
ClinicalTrials.gov identifier: NCT01257399.
Funding
Tillotts Pharma AG.