Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis.

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 ≥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.

• Authors: W Kruis, L Jonaitis, J Pokrotnieks, T L Mikhailova, M Horynski, M Bátovský, Y S Lozynsky, Y Zakharash, I Rácz, K Kull, A Vcev, M Faszczyk, K Dilger, R Greinwald, R Mueller, International Salofalk OD Study Group
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 33 Issue 3 Pg. 313-22 (Feb 2011) ISSN: 1365-2036 [Electronic] England
• PMID: 21138455 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2010 Blackwell Publishing Ltd.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Mesalamine

Topics

• Administration, Oral
• Adult
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
• Colitis, Ulcerative (drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Male
• Mesalamine (administration & dosage)
• Middle Aged
• Remission Induction
• Statistics as Topic
• Time Factors
• Treatment Outcome