| Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. | |
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MedLine Citation:
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PMID: 21070781 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-11-09 |
Journal Detail:
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Title: Gastroenterology Volume: 140 ISSN: 1528-0012 ISO Abbreviation: Gastroenterology Publication Date: 2011 Feb |
Date Detail:
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Created Date: 2011-01-31 Completed Date: 2011-03-28 Revised Date: 2012-04-25 |
Medline Journal Info:
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Nlm Unique ID: 0374630 Medline TA: Gastroenterology Country: United States |
Other Details:
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Languages: eng Pagination: 425-434.e1; quiz e13-4 Citation Subset: AIM; IM |
Copyright Information:
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Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Ev. Krankenhaus Hattingen GmbH, Klinik für Innere Medizin, Hattingen, Germany. a.tromm@krankenhaus-hattingen.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Anti-Inflammatory Agents; 51333-22-3/Budesonide; 89-57-6/Mesalamine |
| Investigator | |
Investigator/Affiliation:
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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:
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Inflamm Bowel Dis. 2012 Apr;18(4):795-6
[PMID:
21739537
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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