Oral budesonide for maintenance treatment of collagenous colitis
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Oral budesonide for maintenance treatment of collagenous colitis : a randomized, double-blind, placebo-controlled trial. / Miehlke, Stephan; Madisch, Ahmed; Bethke, Birgit; Morgner, Andrea; Kuhlisch, Eberhard; Henker, Christine; Vogel, Gerfried; Andersen, Matthias; Meier, Eberhard; Baretton, Gustavo; Stolte, Manfred.
in: GASTROENTEROLOGY, Jahrgang 135, Nr. 5, 11.2008, S. 1510-6.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Oral budesonide for maintenance treatment of collagenous colitis
T2 - a randomized, double-blind, placebo-controlled trial
AU - Miehlke, Stephan
AU - Madisch, Ahmed
AU - Bethke, Birgit
AU - Morgner, Andrea
AU - Kuhlisch, Eberhard
AU - Henker, Christine
AU - Vogel, Gerfried
AU - Andersen, Matthias
AU - Meier, Eberhard
AU - Baretton, Gustavo
AU - Stolte, Manfred
PY - 2008/11
Y1 - 2008/11
N2 - BACKGROUND & 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 (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or=4 consecutive days (and included patients withdrawn because of adverse events).RESULTS: Of 48 enrolled patients, 46 (96%) achieved clinical remission at week 6 and were randomized to maintenance budesonide or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.
AB - BACKGROUND & 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 (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.
KW - Administration, Oral
KW - Adult
KW - Aged
KW - Biopsy
KW - Budesonide
KW - Colitis, Collagenous
KW - Colonoscopy
KW - Dose-Response Relationship, Drug
KW - Double-Blind Method
KW - Female
KW - Follow-Up Studies
KW - Glucocorticoids
KW - Humans
KW - Intestinal Mucosa
KW - Male
KW - Middle Aged
KW - Quality of Life
KW - Remission Induction
KW - Retrospective Studies
KW - Treatment Outcome
KW - Comparative Study
KW - Journal Article
KW - Multicenter Study
KW - Randomized Controlled Trial
U2 - 10.1053/j.gastro.2008.07.081
DO - 10.1053/j.gastro.2008.07.081
M3 - SCORING: Journal article
C2 - 18926826
VL - 135
SP - 1510
EP - 1516
JO - GASTROENTEROLOGY
JF - GASTROENTEROLOGY
SN - 0016-5085
IS - 5
ER -