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A double-blind dose-escalating trial comparing novel mesalazine pellets with mesalazine tablets in active ulcerative
Y Marakhouski1, B Fixa, J Holomán
1Department of Gastroenterology and Nutrition, Byelorussian Medical Academy Postgraduate Education, Minsk, Republic of Belarus.
Background:
Mesalazine as the treatment standard for ulcerative colitis can be applied in different galenical preparations.
Aim:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
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