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Mesalazine granules are superior to Eudragit-L-coated mesalazine tablets for induction of remission in distal ulcerative colitis - a pooled analysis.
MedLine Citation:
PMID:  21923715     Owner:  NLM     Status:  Publisher    
Background  Different oral formulations of 'mesalazine (mesalamine)' may have different efficacy in distal ulcerative colitis. Aim  To evaluate the efficacy of mesalazine granules (Salofalk granules) vs. mesalazine tablets (Salofalk tablets) as induction therapy in patients with distinct extensions of ulcerative colitis. Methods  A pooled analysis of 705 patients from four prospective, randomised, double-blind phase III trials was performed. The efficacy of 8 weeks' induction with 3 g/day mesalazine granules [3 g once daily (o.d.) or 1 g three times daily (t.d.s)] vs. 3 g/day mesalazine tablets (1 g t.d.s.) was compared in terms of clinical remission (CR: CAI ≤ 4) and endoscopic remission (ER: EI ≤ 3) (both according to Rachmilewitz) in subgroups with pancolitis, left-sided colitis, or proctosigmoiditis. Results  Mesalazine granules were equipotent to mesalazine tablets in pancolitis regarding CR (72% vs. 71%, P = 0.909) and ER (58% vs. 49%, P = 0.338). In left-sided colitis, both mesalazine formulations were equipotent regarding CR (66% vs. 67%; P = 0.843) but mesalazine granules were superior regarding ER (56% vs. 37%; P = 0.025). In proctosigmoiditis, mesalazine granules were significantly more effective than mesalazine tablets regarding CR (78% vs. 55%P < 0.001) and ER (67% vs. 43%P < 0.001). Furthermore, o.d. application of mesalazine granules was more effective than t.d.s. dosing in left-sided colitis (CR 73% vs. 62%, P = 0.181; ER 71% vs. 48%P = 0.005) and proctosigmoiditis (CR 86% vs. 73%, P = 0.020; ER 75% vs. 61%, P = 0.021), but not in pancolitis. Conclusion  This pooled analysis supports the hypothesis that mesalazine granules are superior to mesalazine tablets in induction of remission in distal colitis and should be taken once daily.
L Leifeld; R Pfützer; J Morgenstern; P R Gibson; Y Marakhouski; R Greinwald; R Mueller; W Kruis
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-9-19
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  -     ISSN:  1365-2036     ISO Abbreviation:  -     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-9-19     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.
Evangelisches Krankenhaus Kalk, Cologne, Germany. Eastern Health Clinical School, Monash University, Box Hill, Vic., Australia. Belarusian Medical Academy of Post-graduate Education, Gastroenterology Centre, Minsk, Belarus. Dr. Falk Pharma GmbH, Department of Clinical Research & Development, Freiburg, Germany.
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