Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study

Advances in Therapy
Jing Sun, Yaozong Yuan

Abstract

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. 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. 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 tw...Continue Reading

References

Aug 1, 1988·British Journal of Clinical Pharmacology·S A RileyV Mani
Jul 6, 2004·The American Journal of Gastroenterology·Asher KornbluthUNKNOWN Practice Parameters Committee of the American College of Gastroenterology
May 9, 2012·The American Journal of Gastroenterology·Geert D'HaensPaul Streck

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Citations

May 4, 2018·Alimentary Pharmacology & Therapeutics·P SehgalN Narula
Oct 5, 2018·Expert Review of Gastroenterology & Hepatology·Belinda Jackson, Peter De Cruz
Sep 10, 2019·Expert Opinion on Biological Therapy·Catherine Le BerreLaurent Peyrin-Biroulet
Aug 29, 2020·The Cochrane Database of Systematic Reviews·Alistair MurrayJohn K MacDonald

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