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MMX mesalazine for the induction of remission of mild‐to‐moderately active ulcerative colitis: efficacy and tolerability in specific patient subpopulations
Author(s) -
LICHTENSTEIN G. R.,
KAMM M. A.,
SANDBORN W. J.,
LYNE A.,
JOSEPH R. E.
Publication year - 2008
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2008.03688.x
Subject(s) - mesalazine , mmx , medicine , ulcerative colitis , gastroenterology , placebo , tolerability , aminosalicylic acid , colitis , disease , adverse effect , pathology , alternative medicine , computer science , operating system
Summary Background Two phase III studies have evaluated mesalazine (mesalamine) with MMX (Multi Matrix System) technology in patients with active mild‐to‐moderate ulcerative colitis. Aim To determine the efficacy of MMX mesalazine for the induction of clinical and endoscopic remission in specific subgroups of patients with active, mild‐to‐moderate ulcerative colitis. Methods Data from two double‐blind, placebo‐controlled trials were analysed (517 out‐patients). Patients were randomized to receive MMX mesalazine [2.4 g/day (once daily or 1.2 g twice daily) or 4.8 g/day (once daily)] or placebo for 8 weeks. Results The percentages of patients treated with MMX mesalazine, 2.4 or 4.8 g/day, in clinical and endoscopic remission at week 8 were similar and significantly ( P < 0.05) greater than placebo in subgroups stratified by disease extent, disease severity and gender and among patients not previously receiving low‐dose 5‐aminosalicylic acid. Among patients transferring directly from prior low‐dose oral 5‐aminosalicylic acid, MMX mesalazine 4.8 g/day was significantly ( P = 0.018) more effective than placebo in inducing clinical and endoscopic remission. Efficacy over placebo did not reach significance in patients transferring directly to MMX mesalazine 2.4 g/day. Conclusion MMX mesalazine is effective in active UC regardless of disease extent, disease severity, gender and previous, low‐dose, 5‐ASA therapy.