Randomised Clinical Trial
Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis
Article first published online: 4 MAR 2013
© 2013 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 37, Issue 8, pages 767–775, April 2013
How to Cite
Aliment Pharmacol Ther 2013; 37: 767–775
- Issue published online: 18 MAR 2013
- Article first published online: 4 MAR 2013
- Manuscript Revised: 4 FEB 2013
- Manuscript Accepted: 4 FEB 2013
- Manuscript Revised: 3 DEC 2012
- Manuscript Received: 16 NOV 2012
- Ferring Pharmaceuticals
Aminosalicylates are first-choice treatment for mild-to-moderately active ulcerative colitis (UC); however, multi-dosing regimens are inconvenient.
To compare the efficacy and safety of once- (OD) vs. twice- (BD) daily prolonged-release mesalazine (Pentasa, Ferring, Saint-Prex, Switzerland) for active mild-to-moderate UC in a non-inferiority study.
Eligible patients (n = 206) were randomised to 8 weeks of mesalazine (4 g/day), either OD with two sachets of 2 g mesalazine granules in the morning (n = 102) or BD with one 2 g sachet in the morning and one in the evening (n = 104). Patients also received 4 weeks of mesalazine enema 1 g/day. Disease activity was assessed at randomisation, weeks 4, 8 and 12 using the UC Disease Activity Index (UC-DAI). Clinical and endoscopic remission (primary endpoint) was assessed after 8 weeks. Patients recorded stool frequency and rectal bleeding in a daily diary.
The primary endpoint, non-inferiority in clinical and endoscopic remission with OD vs. BD mesalazine at 8 weeks, was met (intent-to-treat population: 52.1% vs. 41.8%, respectively, 95% confidence interval −3.4, 24.1; P = 0.14). Improvement of UC-DAI score (92% vs. 79%; P = 0.01) and mucosal healing (87.5% vs. 71.1%; P = 0.007) were significantly better, time to remission significantly shorter (26 vs. 28 days; P = 0.04) and safety similar with OD vs. BD dosing.
When combined with mesalazine enema, prolonged-release mesalazine once-daily 4 g is as effective and well tolerated as 2 g twice-daily for inducing remission in patients with mild-to-moderately active ulcerative colitis (Clinicaltrials.gov: NCT00737789).