Oral budesonide for maintenance treatment of collagenous colitis

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or=4 consecutive days (and included patients withdrawn because of adverse events).RESULTS: Of 48 enrolled patients, 46 (96%) achieved clinical remission at week 6 and were randomized to maintenance budesonide or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 -