Abstract | BACKGROUND & AIMS: METHODS: This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of long-term therapy with oral budesonide (Entocort CIR capsules) for maintenance of clinical remission of collagenous colitis. Patients were aged >18 years with histologically proven collagenous colitis and >3 watery/loose stools per day on >or=4 of the prior 7 days. Open-label oral budesonide 9 mg/d was administered to all patients for 6 weeks. Patients in clinical remission (<or=3 stools per day) at week 6 were subsequently randomized to double-blind oral treatment with budesonide 6 mg/d or matching placebo for 6 months. Relapse was defined as >3 stools per day on >or=4 consecutive days (and included patients withdrawn because of adverse events). RESULTS: Of 48 enrolled patients, 46 (96%) achieved clinical remission at week 6 and were randomized to maintenance budesonide or placebo. There were 21 relapses during maintenance therapy, and almost all occurred during the first 2 months. Budesonide therapy was associated with a significantly lower cumulative rate of relapse compared with placebo (6/23 [26%] and 15/23 [65%], respectively; P = .022), and high correlation between clinical remission and histologic improvement was observed. Budesonide was well tolerated with no serious adverse events. CONCLUSIONS:
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Authors | Stephan Miehlke, Ahmed Madisch, Birgit Bethke, Andrea Morgner, Eberhard Kuhlisch, Christine Henker, Gerfried Vogel, Matthias Andersen, Eberhard Meier, Gustavo Baretton, Manfred Stolte |
Journal | Gastroenterology
(Gastroenterology)
Vol. 135
Issue 5
Pg. 1510-6
(Nov 2008)
ISSN: 1528-0012 [Electronic] United States |
PMID | 18926826
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Glucocorticoids
- Budesonide
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Topics |
- Administration, Oral
- Adult
- Aged
- Biopsy
- Budesonide
(administration & dosage)
- Colitis, Collagenous
(diagnosis, drug therapy)
- Colonoscopy
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Follow-Up Studies
- Glucocorticoids
(administration & dosage)
- Humans
- Intestinal Mucosa
(pathology)
- Male
- Middle Aged
- Quality of Life
- Remission Induction
- Retrospective Studies
- Treatment Outcome
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