Use this url to cite publication: https://hdl.handle.net/20.500.12512/21339
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Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis / Stephan Miehlke, Ahmed Madisch, Limas Kupcinskas, Dalius Petrauskas, Gerhard Heptner, Günter Böhm, Hans-Joachim Marks, Michael Neumeyer, Torben Nathan, Fernando Fernández-Bañares, Roland Greinwald, Ralf Mohrbacher, Michael Vieth, Ole K. Bonderup; BUC-60/COC Study Group
Type of publication
Straipsnis Web of Science ir Scopus duomenų bazėje / Article in Web of Science and Scopus database (S1)
Author(s)
Miehlke, Stephan | Center for Digestive Diseases Eppendorf, Hamburg, Germany |
Madisch, Ahmed | Siloah Hospital, Hannover, Germany |
Heptner, Gerhard | Gastroenterologists in private practice, Dresden, Germany |
Böhm, Günter | Gastroenterologist in private practice, Ludwigshafen, Germany |
Marks, Hans-Joachim A | Gastroenterologist in private practice, Siegen, Germany |
Neumeyer, Michael | Gastroenterologist in Private Practice, Oldenburg, Germany |
Nathan, Torben | Vejle Sygehus, Vejle, Denmark |
Fernández-Bañares, Fernando | Hospital Universitario Mutua Terrassa, CIBERehd, Terrassa, Spain |
Greinwald, Roland | Dr. Falk Pharma GmbH, Freiburg, Germany |
Mohrbacher, Ralf | Dr. Falk Pharma GmbH, Freiburg, Germany |
Vieth, Michael | Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany |
Bonderup, Ole K | Diagnostic Center, Silkeborg Hospital, Silkeborg, Denmark |
Title
Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis / Stephan Miehlke, Ahmed Madisch, Limas Kupcinskas, Dalius Petrauskas, Gerhard Heptner, Günter Böhm, Hans-Joachim Marks, Michael Neumeyer, Torben Nathan, Fernando Fernández-Bañares, Roland Greinwald, Ralf Mohrbacher, Michael Vieth, Ole K. Bonderup; BUC-60/COC Study Group
Publisher (trusted)
W.B. Saunders |
Is Referenced by
Biological Abstracts |
Date Issued
Date Issued |
---|
2014-01-20 |
Extent
p. 1222-1230.
Is part of
Gastroenterology. Philadelphia, PA : W.B. Saunders, 2014, vol. 146, no. 2.
Version
Originalus / Original
Field of Science
Abstract
Background & Aims Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures. Mesalamine has been proposed as a treatment option for collagenous colitis, although its efficacy has never been investigated in placebo-controlled trials. We performed a phase 3, placebo-controlled multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis. Methods Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules (9 mg budesonide once daily, Budenofalk®, n=30), mesalamine granules (3 g mesalamine once daily, Salofalk®, n=25), or placebo for 8 weeks (n=37) in a double-blind double-dummy fashion. The study was conducted in 31 centers (hospital clinics and private practices) in Germany, Denmark, Lithuania, Spain, and the United Kingdom. The primary endpoint was clinical remission at 8 weeks defined as ≤3 stools/day. Secondary endpoints included clinical remission at 8 weeks, according to the Hjortswang-Criteria of disease activity, taking stool consistency into account. Results A greater percentage of patients in the budesonide group were in clinical remission at week 8 than the placebo group (intention-to-treat analysis, 80.0% vs 59.5%, P=.072; per protocol analysis, 84.8% vs 60.6%, P=.046). Based on the Hjortswang-Criteria, 80.0% of patients given budesonide achieved clinical remission compared with 37.8% of patients given placebo (P=.0006); 44.0% of patients given mesalamine achieved clinical remission, but budesonide was superior to mesalamine (P=.0035). Budesonide significantly improved stool consistency and mucosal histology, and alleviated abdominal pain. The rate of adverse events did not differ among groups. [...].
Type of document
type::text::journal::journal article::research article
ISSN (of the container)
0016-5085
WOS
000334507600023
Other Identifier(s)
(LSMU ALMA)990000832620107106
Coverage Spatial
Jungtinės Amerikos Valstijos / United States of America (US)
Language
Anglų / English (en)
Journal | IF | AIF | AIF (min) | AIF (max) | Cat | AV | Year | Quartile |
---|---|---|---|---|---|---|---|---|
GASTROENTEROLOGY | 16.716 | 4.111 | 4.111 | 4.111 | 1 | 4.066 | 2014 | Q1 |
Journal | IF | AIF | AIF (min) | AIF (max) | Cat | AV | Year | Quartile |
---|---|---|---|---|---|---|---|---|
GASTROENTEROLOGY | 16.716 | 4.111 | 4.111 | 4.111 | 1 | 4.066 | 2014 | Q1 |
Journal | Cite Score | SNIP | SJR | Year | Quartile |
---|---|---|---|---|---|
Gastroenterology | 21.9 | 3.662 | 6.648 | 2014 | Q1 |