Please use this identifier to cite or link to this item:
10.1111/j.1365-2036.2010.04537.x
Title: | Randomised clinical trial : A comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis |
Authors: | 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. |
Keywords: | 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) |
Issue Date: | Feb-2011 |
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 |
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. |
DOI: | 10.1111/j.1365-2036.2010.04537.x |
ISSN: | 0269-2813 |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
Files in This Item:
File | Size | Format | |
---|---|---|---|
Randomised_clinical_trial.pdf | 256.18 kB | Adobe PDF | View/Open![]() |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.