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- Title
Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis.
- Authors
GIBSON, P. R.; FIXA, B.; PEKÁRKOVÁ, B.; BÁTOVSKÝ, M.; RADFORD‐SMITH, G.; TIBITANZL, J.; GABALEC, L.; FLORIN, T. H. J.; GREINWALD, R.
- Abstract
Background There are no comparative studies of coated mesalazine. Aim To compare the efficacy and tolerability of Eudragit-L- and ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis. Methods A double-blind, double-dummy, randomized parallel group trial was performed across 18 centres in Australia, and 20 in Eastern Europe. Patients were treated with 3 g mesalazine for 8 weeks with the primary efficacy end point being clinical remission. Results Of 215 patients, 69% achieved clinical remission in both treatment groups ( P < 0.001; chi-square test) with no differences in frequency of adverse events. In the Australian cohort ( n = 63), the Eudragit-L group had a higher remission rate (73% vs. 36%) and responded 13 days faster, compared with those in the European group (67% vs. 84%, and 2 days respectively). No clear reasons for differences in treatment responses were identified. Conclusions Eudragit-L and ethylcellulose-coated mesalazine tablets are well tolerated and equally effective in achieving remission in mild-moderately active ulcerative colitis over 8 weeks.
- Subjects
AUSTRALIA; ULCERATIVE colitis; COLITIS treatment; DRUG efficacy; DRUG tablets; SOLID dosage forms
- Publication
Alimentary Pharmacology & Therapeutics, 2006, Vol 23, Issue 7, p1017
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/j.1365-2036.2006.02861.x