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Early symptomatic response and mucosal healing with mesalazine rectal suspension therapy in active distal ulcerative colitis - additional results from two controlled studies.
MedLine Citation:
PMID:  21848857     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Background  Rapid resolution of symptoms and endoscopic inflammation in ulcerative colitis (UC) represent important treatment goals. Aims  To establish times to bleeding cessation and endoscopic healing for topical and oral mesalazine in active distal UC, a post hoc analysis of two published studies was performed. Methods  Study I (Sutherland 1987) compared mesalazine rectal suspension to placebo, while Study II (Safdi 1997) compared topical suspensions, either alone or in combination with oral mesalazine, and oral alone. Cessation of rectal bleeding (RB) was defined as absence of bleeding on four consecutive days. Endoscopic remission was defined as DAI mucosal healing (MH) subscore = 0 and clinical remission as MH subscore = 0-1 and ≥ 1-point improvement, plus RB subscore = 0. Results  Study I: By Day 2, 31.4% of subjects using topical monotherapy reported no RB vs. 5.5% in the placebo arm (P < 0.0006); median time to RB cessation was 8 days. Significantly higher rates of endoscopic (25.0% vs. 7.8%, P < 0.005) and clinical remission (48.6% vs. 9.6%, P < 0.0001) were observed at Week 3. Study II: A significantly higher proportion of subjects achieved RB cessation with combination therapy vs. oral therapy, commencing by Day 8. By Week 3, a significantly higher proportion of subjects using combination therapy achieved clinical remission compared to oral therapy alone (57.9% vs. 18.2%, P < 0.05). Conclusions  Topical mesalazine suspension, either alone or in combination with oral mesalazine, led to earlier rectal bleeding cessation and mucosal healing. These data support use of topical therapy for more rapid treatment benefit in active distal ulcerative colitis.
Authors:
W J Sandborn; S Hanauer; G R Lichtenstein; M Safdi; M Edeline; M Scott Harris
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-8-16
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  -     ISSN:  1365-2036     ISO Abbreviation:  -     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-8-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2011 Blackwell Publishing Ltd.
Affiliation:
Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA. Department of Medicine, Pritzker School of Medicine, University of Chicago, Chicago, IL, USA. Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA. Ohio Gastroenterology and Liver Institute, Cincinnati, OH, USA. Meda Pharmaceuticals, Marietta, GA, USA. Department of Medicine, Georgetown University School of Medicine, Washington, DC, USA.
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