Document Detail


Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease.
MedLine Citation:
PMID:  21070781     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD.
METHODS: We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-L-coated oral mesalamine (4.5 g/day).
RESULTS: The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index ≤150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (Δ70) or 100 or more (Δ100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Δ70, P = .11; Δ100, P = .15), or between the 2 budesonide groups (Δ70, P = .38; Δ100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups.
CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen.
Authors:
Andreas Tromm; Ivan Bunganič; Eva Tomsová; Zsolt Tulassay; Milan Lukáš; Jan Kykal; Marian Bátovský; Bohumil Fixa; Libor Gabalec; Rifaat Safadi; Heinz-Jochen Kramm; István Altorjay; Hanns Löhr; Ioannis Koutroubakis; Simon Bar-Meir; Davor Stimac; Elke Schäffeler; Christoph Glasmacher; Karin Dilger; Ralf Mohrbacher; Roland Greinwald;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-11-09
Journal Detail:
Title:  Gastroenterology     Volume:  140     ISSN:  1528-0012     ISO Abbreviation:  Gastroenterology     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-31     Completed Date:  2011-03-28     Revised Date:  2012-04-25    
Medline Journal Info:
Nlm Unique ID:  0374630     Medline TA:  Gastroenterology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  425-434.e1; quiz e13-4     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
Affiliation:
Ev. Krankenhaus Hattingen GmbH, Klinik für Innere Medizin, Hattingen, Germany. a.tromm@krankenhaus-hattingen.de
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Inflammatory Agents / adverse effects,  therapeutic use*
Budesonide / adverse effects,  therapeutic use*
Crohn Disease / drug therapy*
Double-Blind Method
Female
Humans
Male
Mesalamine / adverse effects,  therapeutic use*
Middle Aged
Remission Induction
Severity of Illness Index
Smoking
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents; 51333-22-3/Budesonide; 89-57-6/Mesalamine
Investigator
Investigator/Affiliation:
Mate Kozic / ; Milan Kujundzic / ; Stjepan Miše / ; Davor Štimac / ; Aleksandar Vcev / ; Bohumil Fixa / ; Josef Dosedel / ; Ladislav Douda / ; Libor Gabalec / ; Michal Konecný / ; Jan Kykal / ; Jirí Laštùvka / ; Milan Lukáš / ; Eva Tomsová / ; Ondrej Urban / ; Dana Voharciková / ; Vladimir Zboril / ; Hüppe Dietrich / ; Andreas Kocjan / ; Heinz-Jochen Kramm / ; Hanns Löhr / ; Stephan Miehlke / ; Moritz Müser / ; Stefan Zeuzem / ; Ioannis Koutroubakis / ; Gerassimos J Mantzaris / ; István Altorjay / ; Zoltan Döbrönte / ; Zsolt Dubravcsik / ; István Rácz / ; Zsolt Tulassay / ; László Újszászy / ; Simon-Bar Meir / ; Iris Dotan / ; Mark Faszczyk / ; Zvi Fireman / ; Fred Konikoff / ; Ehud Melzer / ; Yaron Niv / ; Rifaat Safadi / ; Eitan Scapa / ; Boris Barický / ; Marian Bátovský / ; Ivan Bunganic / ; Igor Katancík / ; Božena Pekárková / ; Martin Krauss / ; Tilo Andus / ; Gerhard Rogler /
Comments/Corrections
Comment In:
Inflamm Bowel Dis. 2012 Apr;18(4):795-6   [PMID:  21739537 ]

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