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Oral budesonide for maintenance treatment of collagenous colitis: a randomized, double-blind, placebo-controlled trial.

AbstractBACKGROUND & AIMS:
Oral budesonide effectively induces clinical remission in patients with collagenous colitis, a debilitating illness characterized by chronic watery/loose diarrhea, but there is a high rate of relapse after treatment cessation.
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or=4 consecutive days (and included patients withdrawn because of adverse events).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:
Oral budesonide 6 mg/d is efficacious and well tolerated for long-term maintenance of clinical remission in patients with collagenous colitis.
AuthorsStephan Miehlke, Ahmed Madisch, Birgit Bethke, Andrea Morgner, Eberhard Kuhlisch, Christine Henker, Gerfried Vogel, Matthias Andersen, Eberhard Meier, Gustavo Baretton, Manfred Stolte
JournalGastroenterology (Gastroenterology) Vol. 135 Issue 5 Pg. 1510-6 (Nov 2008) ISSN: 1528-0012 [Electronic] United States
PMID18926826 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Glucocorticoids
  • Budesonide
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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