Document Detail


Oral pH-modified release budesonide versus 6-methylprednisolone in active Crohn's disease. German/Austrian Budesonide Study Group.
MedLine Citation:
PMID:  8889459     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Corticosteroids are effective in acute Crohn's disease (CD). The present study assessed the effectiveness and safety of oral pH-modified release budesonide (BUD) in patients with active CD in comparison with 6-methylprednisolone (MPred). DESIGN: This was a prospective multicentre, randomized, double-blind, double-dummy study. METHODS: A total of 67 patients with active CD (CDAI > 150) were included. Patients were treated with 3 x 3 mg BUD (n = 34) or MPred (n = 33) according to a weekly tapering schedule (48-32-24-20-16-12-8 mg). The primary aim was remission of CD (CDAI < 150 and decrease by at least 60 points from baseline) after eight weeks. RESULTS: Baseline demographics, disease activity and localization of CD in the small bowel and the colon were similar in both treatment groups. On an intention-to-treat basis 19/34 patients in the BUD group (55.9%) and 24/33 patients in the MPred group (72.7%) were in remission after eight weeks (P = 0.237). Therapy failed in 15/34 patients (44.1%) of the BUD group and in 9/33 patients (27.3%) of the MPred group. The mean CDAI decreased from 262 +/- 50 to 118 +/- 69 in the BUD-group and from 262 +/- 81 to 95 +/- 61 in the Mored group (P = 0.183, final CDAI BUD vs. MPred). Steroid-related side effects appeared in 28.6% of the patients in the BUD group and in 69.7% of the patients in the Mored group (P = 0.0015). CONCLUSIONS: Oral pH-modified release budesonide (3 x 3 mg/day) is almost as effective as a conventional corticosteroid in patients with active CD but causes significantly less corticosteroid-related side effects.
Authors:
V Gross; T Andus; I Caesar; S C Bischoff; H Lochs; A Tromm; H J Schulz; U Bär; A Weber; M Gierend; K Ewe; J Schölmerich
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of gastroenterology & hepatology     Volume:  8     ISSN:  0954-691X     ISO Abbreviation:  Eur J Gastroenterol Hepatol     Publication Date:  1996 Sep 
Date Detail:
Created Date:  1997-01-14     Completed Date:  1997-01-14     Revised Date:  2009-10-16    
Medline Journal Info:
Nlm Unique ID:  9000874     Medline TA:  Eur J Gastroenterol Hepatol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  905-9     Citation Subset:  IM    
Affiliation:
Department of Internal Medicine, Universities of Regensburg.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Anti-Inflammatory Agents / administration & dosage,  therapeutic use*
Budesonide
Crohn Disease / drug therapy*
Delayed-Action Preparations
Double-Blind Method
Drug Administration Schedule
Female
Glucocorticoids / administration & dosage,  therapeutic use*
Humans
Hydrogen-Ion Concentration
Male
Methylprednisolone / administration & dosage,  therapeutic use*
Middle Aged
Pregnenediones / administration & dosage,  therapeutic use*
Prospective Studies
Remission Induction
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Delayed-Action Preparations; 0/Glucocorticoids; 0/Pregnenediones; 51333-22-3/Budesonide; 83-43-2/Methylprednisolone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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