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Gibson, P.R. et al.

Gibson, Fixa, Pekárková, Bátovský, Radford-Smith, Tibitanzl, Gabalec, Florin, Greinwald,

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.

Summary 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.[1]

References

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., Pekárková, B., Bátovský, M., Radford-Smith, G., Tibitanzl, J., Gabalec, L., Florin, T.H., Greinwald, R. Aliment. Pharmacol. Ther. (2006) [Pubmed]

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