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

Gibson, P. R., Fixa, B., Pekarkova, B., Batovsky, M., Radford-Smith, G., Tibitanzl, J., Gabalec, L., Florin, T. H. J. and Greinwald, R. (2006) 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. Alimentary Pharmacology & Therapeutics, 23 7: 1017-1026. doi:10.1111/j.1365-2036.2006.02861.x


Author Gibson, P. R.
Fixa, B.
Pekarkova, B.
Batovsky, M.
Radford-Smith, G.
Tibitanzl, J.
Gabalec, L.
Florin, T. H. J.
Greinwald, R.
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
Journal name Alimentary Pharmacology & Therapeutics   Check publisher's open access policy
ISSN 0269-2813
Publication date 2006
Sub-type Article (original research)
DOI 10.1111/j.1365-2036.2006.02861.x
Volume 23
Issue 7
Start page 1017
End page 1026
Total pages 10
Editor R. E. Pounder
W. L. Peterson
Place of publication UK
Publisher Blackwell Publishing Ltd
Collection year 2006
Language eng
Subject C1
321006 Gastroenterology and Hepatology
730113 Digestive system and disorders
Formatted 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.
Keyword Gastroenterology & Hepatology
Pharmacology & Pharmacy
Oral 5-aminosalicylic Acid
Inflammatory-bowel-disease
Double-blind
Olsalazine
Delivery
Trial
Sulfasalazine
Epidemiology
Management
Remission
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
2007 Higher Education Research Data Collection
School of Medicine Publications
 
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Created: Wed, 15 Aug 2007, 10:41:26 EST