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
Open Access
- 4 May 2007
- journal article
- research article
- Published by Wiley in Alimentary Pharmacology & Therapeutics
- Vol. 26 (2), 205-215
- https://doi.org/10.1111/j.1365-2036.2007.03361.x
Abstract
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 calculated as: rectal bleeding and stool frequency scores of 0, a combined Physician’s Global Assessment and sigmoidoscopy score of ≤1, no mucosal friability and a ≥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.Keywords
This publication has 29 references indexed in Scilit:
- Once-Daily, High-Concentration MMX Mesalamine in Active Ulcerative ColitisGastroenterology, 2007
- Guidelines for the management of inflammatory bowel disease in adultsGut, 2004
- Short‐term adverse effects of 5‐aminosalicylic acid agents in the treatment of ulcerative colitisAlimentary Pharmacology & Therapeutics, 2004
- The optimal dose of 5-aminosalicylic acid in active ulcerative colitis: A dose-finding study with newly developed mesalamineClinical Gastroenterology and Hepatology, 2003
- The pharmacokinetic profiles of oral mesalazine formulations and mesalazine pro‐drugs used in the management of ulcerative colitisAlimentary Pharmacology & Therapeutics, 2002
- Balsalazide is more effective and better tolerated than mesalamine in the treatment of acute ulcerative colitisGastroenterology, 1998
- Olsalazine versus placebo in the treatment of mild to moderate ulcerative colitis: a randomised double blind trial.Gut, 1989
- Coated Oral 5-Aminosalicylic Acid Therapy for Mildly to Moderately Active Ulcerative ColitisNew England Journal of Medicine, 1987
- Controlled trial of sulphasalazine in the treatment of ulcerative colitisGut, 1964
- SULPHASALAZINE AND SALICYLAZOSULPHADIMIDINE IN ULCERATIVE COLITISThe Lancet, 1962