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A double‐blind dose‐escalating trial comparing novel mesalazine pellets with mesalazine tablets in active ulcerative colitis
Author(s) -
Marakhouski Y.,
Fixa B.,
Holomán J.,
Hulek P.,
Lukas M.,
Bátovský M.,
Rumyantsev V. G.,
Grigoryeva G.,
Stolte M.,
Vieth M.,
Greinwald R.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02312.x
Subject(s) - mesalazine , medicine , ulcerative colitis , gastroenterology , pellets , colitis , randomized controlled trial , disease , geology , oceanography
Summary 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 ≤ 4) for pellets was 67% vs. 68% for tablets which statistically proved to be not inferior (significance level α = 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.