Clinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis – a 6-month placebo-controlled trial
Article first published online: 18 AUG 2010
© 2010 Salix Pharmaceuticals
Alimentary Pharmacology & Therapeutics
Volume 32, Issue 8, pages 990–999, October 2010
How to Cite
Lichtenstein, G. R., Gordon, G. L., Zakko, S., Murthy, U., Sedghi, S., Pruitt, R., Merchant, K., Shaw, A., Bortey, E. and Forbes, W. P. (2010), Clinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis – a 6-month placebo-controlled trial. Alimentary Pharmacology & Therapeutics, 32: 990–999. doi: 10.1111/j.1365-2036.2010.04438.x
- Issue published online: 26 SEP 2010
- Article first published online: 18 AUG 2010
- Publication data Submitted 28 June 2010 First decision 5 July 2010 Resubmitted 28 July 2010 Accepted 29 July 2010
Aliment Pharmacol Ther 2010; 32: 990–999
Background Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder.
Aim To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC.
Methods Randomized, double-blind, placebo-controlled trial of patients (n = 209 MG, n = 96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare.
Results The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician’s disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups.
Conclusions Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.