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A double-blind dose-escalating trial comparing novel mesalazine pellets with mesalazine tablets in active ulcerative colitis

Content Provider	Scilit
Author	Marakhouski, Yury Fixa, B. Holomáň, J. Hůlek, P. Lukas, Milan Batovsky, M. Rumyantsev, V. G. Grigoryeva, G. Stolte, M. Vieth, M. Greinwald, R.
Copyright Year	2005
Description	Journal: Alimentary Pharmacology & Therapeutics Mesalazine as the treatment standard for ulcerative colitis can be applied in different galenical preparations. A novel formulation of mesalazine pellets with delayed and prolonged release characteristics was compared with conventional Eudragit L-coated tablets. Furthermore, the effect of mesalazine dose escalation on nonresponders was evaluated in both treatment groups. A total of 233 patients with mild to moderately active ulcerative colitis were randomized to receive either mesalazine (1.5 g/day in three doses) as pellets (n = 115) or tablets (n = 118) for 8 weeks. At insufficient response, the dose was increased to 3.0 g. The clinical remission rate (clinical activity index < or = 4) for pellets was 67% vs. 68% for tablets which statistically proved to be not inferior (significance level alpha = 2.5%). In patients without dose increase, the remission rate was 47% (pellets) vs. 42% (tablets). Endoscopic improvement was observed in 80% (pellets) vs. 83% (tablets), and histological improvement in 48% (pellets) vs. 52% (tablets) of patients. Mesalazine pellets are as effective as tablets in the treatment of mild to moderately active ulcerative colitis. Dose escalation to 3.0 g/day is a valid option for nonresponders to a starting dose of 1.5 g/day.
Related Links	http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2005.02312.x/pdf
Ending Page	140
Page Count	8
Starting Page	133
e-ISSN	13652036
DOI	10.1111/j.1365-2036.2005.02312.x
Journal	Alimentary Pharmacology & Therapeutics
Issue Number	2
Volume Number	21
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2005-01-01
Access Restriction	Open
Subject Keyword	Journal: Alimentary Pharmacology & Therapeutics Gastroenterology and Hepatology Mesalazine Pellets Patients Without Dose Active Ulcerative Colitis
Content Type	Text
Resource Type	Article

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