Members of the International Salofalk OD Study Group are listed in the Appendix.
Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis
Article first published online: 8 DEC 2010
© 2010 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 33, Issue 3, pages 313–322, February 2011
How to Cite
Kruis, W., Jonaitis, L., Pokrotnieks, J., Mikhailova, T. L., Horynski, M., Bátovský, M., Lozynsky, Y. S., Zakharash, Y., Rácz, I., Kull, K., Vcev, A., Faszczyk, M., Dilger, K., Greinwald, R., Mueller, R. and the International Salofalk OD Study Group (2011), Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. Alimentary Pharmacology & Therapeutics, 33: 313–322. doi: 10.1111/j.1365-2036.2010.04537.x
- Issue published online: 4 JAN 2011
- Article first published online: 8 DEC 2010
- Publication data Submitted 20 October 2010 First decision 8 November 2010 Resubmitted 17 November 2010 Accepted 18 November 2010 EV Pub Online 8 December 2010
Vol. 34, Issue 11-12, 1357, Article first published online: 16 NOV 2011
Aliment Pharmacol Ther 2011; 33: 313–322
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 ≥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.