MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials.

MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Research Abstract Details 

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MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Abstract Text:

W J Sandborn,M A Kamm,G R Lichtenstein,A Lyne,T Butler,R E Joseph,W J Sandborn,M A Kamm,G R Lichtenstein,A Lyne,T Butler,R E Joseph,

BACKGROUND: MMX mesalazine [LIALDA (US), MEZAVANT XL (UK and Ireland) MEZAVANT (elsewhere)] utilizes MMX Multi Matrix System (MMX) technology which delivers mesalazine throughout the colon. Two phase III studies have already evaluated MMX mesalazine in patients with active, mild-to-moderate ulcerative colitis. Aim To provide more precise estimates of the efficacy of MMX mesalazine over placebo by combining the patient populations from the two phase III studies. Methods Combined data from two 8-week, double-blind, placebo-controlled trials were analyzed. Patients randomized to MMX mesalazine 2.4 g/day (once daily or 1.2 g twice daily), 4.8 g/day (once daily) or placebo were reviewed. The primary end point was clinical and endoscopic remission (modified Ulcerative Colitis-Disease Activity Index of /=1-point reduction in sigmoidoscopy score from week 0). Results Data from 517 patients were analysed. 8-week remission rates were 37.2% and 35.1% in the MMX mesalazine 2.4 g/day and 4.8 g/day groups, vs. 17.5% on placebo (P < 0.001, both comparisons). 8-week complete mucosal healing rates were 32% in both MMX mesalazine groups compared with 16% on placebo. Adverse event frequency was similar in all groups. Conclusion MMX mesalazine is effective and generally well tolerated for inducing clinical and endoscopic remission of active, mild-to-moderate ulcerative colitis.

MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Publishing Authors By Initials

WJ Sandborn,MA Kamm,GR Lichtenstein,A Lyne,T Butler,RE Joseph,WJ Sandborn,MA Kamm,GR Lichtenstein,A Lyne,T Butler,RE Joseph,

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MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Alimentary pharmacology & therapeutics

VOLUME: 26

Page Numbers: 205-15

Journal Abbreviation: Aliment. Pharmacol. Ther.

ISSN: 0269-2813

DAY: 15

MONTH: Jul

YEAR: 2007

MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized, double-blind, placebo-controlled trials. Information

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LANGUAGE: eng

NlmUniqueID: 8707234

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AFFILIATION: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, USA. sandborn.william@mayo.edu

Country: England

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MEDLINETA: Aliment Pharmacol Ther

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