Randomised clinical trial : A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis
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Date
2011-02
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Abstract
Background Comparative data regarding different regimens of oral mesalazine (mesalamine) for maintaining remission in ulcerative colitis are limited. Aim To evaluate whether 3.0 g mesalazine once-daily (OD) is superior to the standard treatment of 0.5 g mesalazine three times daily (t.d.s.) and to prove the therapeutic equivalence of OD vs. t.d.s. dosing of total 1.5 g mesalazine for remission maintenance in patients with ulcerative colitis. Methods A 1-year, multicentre, double-blind, double-dummy study was undertaken in patients with endoscopically and histologically confirmed ulcerative colitis in remission. Patients were randomised to oral mesalazine 3.0 g OD, 1.5 g OD or 0.5 g t.d.s. The primary efficacy endpoint was the proportion of patients still in clinical remission at the final visit, with clinical relapse being defined as CAI score >4 and an increase of â¥3 from baseline. Results The primary efficacy endpoint occurred in 162/217 3.0 g OD patients (75%), 129/212 1.5 g OD patients (61%) and 150/218 0.5 g t.d.s. patients (69%) in the intention-to-treat population, and in 152/177 (86%), 121/182 (67%) and 144/185 (78%) in the per protocol population respectively; 3.0 g OD was superior to both low-dose regimens for the primary endpoint (i.e. P < 0.001, 3.0 g OD vs. 1.5 g OD; P = 0.024, 3.0 g OD vs. 0.5 g t.d.s.; superiority test, per protocol population). Safety analysis, including comprehensive renal monitoring, revealed no concern in any treatment group. Conclusion Mesalazine 3.0 g once daily was the most effective dose for maintenance of remission in ulcerative colitis of the three regimens assessed, with no penalty in terms of safety.
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3.2 Clinical medicine, 3.1 Basic medicine, 1.1. Scientific article indexed in Web of Science and/or Scopus database, Hepatology, Gastroenterology, Pharmacology (medical)
Citation
Kruis, W, Jonaitis, L, Pokrotnieks, J, Mikhailova, T L, Horynski, M, Bátovskã, M, Lozynsky, Y S, Zakharash, Y, Rácz, I, Kull, K, Vcev, A, Faszczyk, M, Dilger, K, Greinwald, R & Mueller, R 2011, 'Randomised clinical trial : A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis', Alimentary Pharmacology and Therapeutics, vol. 33, no. 3, pp. 313-322. https://doi.org/10.1111/j.1365-2036.2010.04537.x