Oral Budesonide for Maintenance Treatment of Collagenous Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial
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 ≥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) 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3 stools per day on ≥4 consecutive days (and included patients withdrawn because of adverse events).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.
Abbreviations used in this paper: HRQOL, health-related quality of life, sIBDQ, Short Inflammatory Bowel Disease Questionnaire, SF-36, Medical Outcome Short Form 36
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The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and analysis.
All authors contributed to interpretation of the study findings and in the writing of the manuscript. Medical writing support was provided by Steve Winter, from Wolters Kluwer Health (Chester, UK), with funding from AstraZeneca.
The authors are indebted to the following investigators for their participation in this study: W. Barina, Würzburg; N. Bockelmann, Gedern; F. Emke, Osnabrück; G. Franke, Dinkelsbühl; S. Gernert, Ochsenfurt; B. Grosse, Willich; J. Grossmann, Mönchengladbach; C. Haferland, Görlitz; T. Henn, Bad Kissingen; W. Hennig, Bayreuth; T. Höhler, Recklinghausen; I. Hofmann, Stadtsteinach; J. Kärner, Trier; J. Keymling, Wedemark; R. Kölble, Düsseldorf; C. Krödel, Bad Brückenau; G. Lösken, Melle; C. Lücke, Beilstein; A. Lütke, Koblenz; S. Mielck, Plön; T. Montag, Eutin; H. Peβler, Ahorntal; J. Philipzik, Aldingen; F. Richter, Sigmaringen; J. Rintelmann, Bad Nenndorf; A. Rodenbostel, Baden-Baden; S. Roder, Talheim; J. Scholle, Menden; K. Schultze, Bremerhaven; W. Simon, Würzburg; T. Sokolowski, München; G. Walker, Pirmasens; W. Weber, Berlin; B. Wigginghaus, Osnabrück; and M. Zimmermann, Konradsreuth.
The authors disclose the following: Potential investigator conflicts of interest, where relevant, were not disclosed to study participants.
The statistical analysis of the entire data sets pertaining to efficacy (specifically primary and major secondary efficacy end points) and safety was independently conducted by a biostatistician (EK) who is not employed by the study sponsor.
Supported by AstraZeneca.
SM has received honoraria from AstraZeneca for consultancies and oral presentations, and research grant support from AstraZeneca. AMa has received honoraria from AstraZeneca for consultancies, oral presentations, and research grant support from AstraZeneca. AMo has received honoraria from AstraZeneca for consultancies and oral presentations. MS has received honoraria as an invited speaker for AstraZeneca. BB, EK, CH, GV, MA and GB have no conflicts of interest to declare.
PII: S0016-5085(08)01457-1
doi:10.1053/j.gastro.2008.07.081
© 2008 AGA Institute. Published by Elsevier Inc. All rights reserved.
