Document Detail


Mesalazine in left-sided ulcerative colitis: Efficacy analyses from the PODIUM trial on maintenance of remission and mucosal healing.
MedLine Citation:
PMID:  22398060     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND AND AIM: Left-sided colitis is the most prevalent subtype of ulcerative colitis, a chronic inflammatory disease of the colon. The standard of care for mild-to-moderate ulcerative colitis is mesalazine. The PODIUM study compared a once daily to a twice daily dosing regimen of a slow-release mesalazine (Pentasa®); here we assess the efficacy, in terms of maintenance of remission and mucosal healing, of both regimens in patients with left-sided disease. PATIENTS AND METHODS: Eligible patients were randomised to once daily (1×2g) or twice daily (2×1g) oral treatment with mesalazine, for 12months. Disease activity was assessed clinically and endoscopically at baseline and at 12months using the Ulcerative Colitis Disease Activity Index, without endoscopic assessment at months 4 and 8. RESULTS: The study met the primary endpoint of non-inferiority in terms of remission, for once daily versus twice daily dosing, in patients with left-sided ulcerative colitis; an 8% difference was reported in the 12-month clinical and endoscopic remission rates (69% [95% CI: 59.5-76.5] and 61% [95% CI: 51.4-69.6] with once daily and twice daily dosing, respectively; p=0.310). Mucosal healing scores after 12months were 0 or 1 for 84.4% of the once daily and 78.8% of the twice daily population. Slow-release mesalazine was well tolerated in both dosing regimens, with no difference in reported adverse events. CONCLUSIONS: Once daily slow-release mesalazine is similarly effective to the standard twice daily schedule in patients with left-sided ulcerative colitis for the maintenance of remission in mild-to-moderate disease.
Authors:
Bernd Bokemeyer; Daan Hommes; Ivo Gill; Per Broberg; Axel Dignass
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-11-10
Journal Detail:
Title:  Journal of Crohn's & colitis     Volume:  -     ISSN:  1876-4479     ISO Abbreviation:  -     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2012-3-8     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101318676     Medline TA:  J Crohns Colitis     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.
Affiliation:
Gastroenterology Practice Minden, Minden, Germany; Clinic of General Medicine I, University Medical Centre of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
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