Abstract | BACKGROUND & AIMS: 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 end point was clinical remission at 8 weeks defined as ≤ 3 stools per day. Secondary end points 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. CONCLUSIONS: Oral budesonide (9 mg once daily) is effective and safe for short-term treatment of collagenous colitis. Short-term treatment with oral mesalamine (3 g once daily) appears to be ineffective. ClinicalTrials.gov number, NCT00450086.
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Authors | Stephan Miehlke, Ahmed Madisch, Limas Kupcinskas, Dalius Petrauskas, 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 |
Journal | Gastroenterology
(Gastroenterology)
Vol. 146
Issue 5
Pg. 1222-30.e1-2
(May 2014)
ISSN: 1528-0012 [Electronic] United States |
PMID | 24440672
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anti-Inflammatory Agents
- Capsules
- Delayed-Action Preparations
- Gastrointestinal Agents
- Mesalamine
- Budesonide
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Topics |
- Administration, Oral
- Adult
- Aged
- Anti-Inflammatory Agents
(administration & dosage, adverse effects, therapeutic use)
- Budesonide
(administration & dosage, adverse effects, therapeutic use)
- Capsules
- Colitis, Collagenous
(complications, diagnosis, drug therapy, physiopathology)
- Defecation
(drug effects)
- Delayed-Action Preparations
- Double-Blind Method
- Europe
- Female
- Gastrointestinal Agents
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Male
- Mesalamine
(administration & dosage, adverse effects, therapeutic use)
- Middle Aged
- Remission Induction
- Time Factors
- Treatment Outcome
- Young Adult
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