Stephan Miehlke1, Ahmed Madisch2, Limas Kupcinskas3, Dalius Petrauskas3, Günter Böhm4, Hans-Joachim Marks5, Michael Neumeyer6, Torben Nathan7, Fernando Fernández-Bañares8, Roland Greinwald9, Ralf Mohrbacher9, Michael Vieth10, Ole K Bonderup11. 1. Center for Digestive Diseases Eppendorf, Hamburg, Germany. Electronic address: prof.miehlke@mdz-hamburg.de. 2. Medical Department I, Siloah Hospital, Hannover, Germany. 3. Institute for Digestive Research, Lithuanian, University of Health Sciences, Kaunas, Lithuania. 4. Private Practice, Ludwigshafen, Germany. 5. Private Practice, Siegen, Germany. 6. Private Practice, Oldenburg, Germany. 7. Vejle Sygehus, Vejle, Denmark. 8. Department of Gastroenterology, Hospital Universitario Mutua Terrassa, Terrassa, Spain. 9. Dr Falk Pharma GmbH, Freiburg, Germany. 10. Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany. 11. Diagnostic Center, Silkeborg Hospital, Silkeborg, Denmark.
Abstract
BACKGROUND & AIMS: Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures. Mesalamine has been proposed as a treatment option for collagenous colitis, although its efficacy has never been investigated in placebo-controlled trials. We performed a phase 3, placebo-controlled, multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis. METHODS:Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules (9 mg budesonide once daily, Budenofalk, n = 30), mesalamine granules (3 g mesalamine once daily, Salofalk, n = 25), or placebo for 8 weeks (n = 37) in a double-blind, double-dummy fashion. The study was conducted in 31 centers (hospital clinics and private practices) in Germany, Denmark, Lithuania, Spain, and the United Kingdom. The primary end point was clinical remission at 8 weeks defined as ≤ 3 stools per day. Secondary end points included clinical remission at 8 weeks, according to the Hjortswang-Criteria of disease activity, taking stool consistency into account. RESULTS: A greater percentage of patients in the budesonide group were in clinical remission at week 8 than the placebo group (intention-to-treat analysis, 80.0% vs 59.5%; P = .072; per-protocol analysis, 84.8% vs 60.6%; P = .046). Based on the Hjortswang-Criteria, 80.0% of patients given budesonide achieved clinical remission compared with 37.8% of patients given placebo (P = .0006); 44.0% of patients given mesalamine achieved clinical remission, but budesonide was superior to mesalamine (P = .0035). Budesonide significantly improved stool consistency and mucosal histology, and alleviated abdominal pain. The rate of adverse events did not differ among groups. CONCLUSIONS:Oral budesonide (9 mg once daily) is effective and safe for short-term treatment of collagenous colitis. Short-term treatment with oral mesalamine (3 g once daily) appears to be ineffective. ClinicalTrials.gov number, NCT00450086.
RCT Entities:
BACKGROUND & AIMS: Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures. Mesalamine has been proposed as a treatment option for collagenous colitis, although its efficacy has never been investigated in placebo-controlled trials. We performed a phase 3, placebo-controlled, multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis. METHODS:Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules (9 mg budesonide once daily, Budenofalk, n = 30), mesalamine granules (3 g mesalamine once daily, Salofalk, n = 25), or placebo for 8 weeks (n = 37) in a double-blind, double-dummy fashion. The study was conducted in 31 centers (hospital clinics and private practices) in Germany, Denmark, Lithuania, Spain, and the United Kingdom. The primary end point was clinical remission at 8 weeks defined as ≤ 3 stools per day. Secondary end points included clinical remission at 8 weeks, according to the Hjortswang-Criteria of disease activity, taking stool consistency into account. RESULTS: A greater percentage of patients in the budesonide group were in clinical remission at week 8 than the placebo group (intention-to-treat analysis, 80.0% vs 59.5%; P = .072; per-protocol analysis, 84.8% vs 60.6%; P = .046). Based on the Hjortswang-Criteria, 80.0% of patients given budesonide achieved clinical remission compared with 37.8% of patients given placebo (P = .0006); 44.0% of patients given mesalamine achieved clinical remission, but budesonide was superior to mesalamine (P = .0035). Budesonide significantly improved stool consistency and mucosal histology, and alleviated abdominal pain. The rate of adverse events did not differ among groups. CONCLUSIONS: Oral budesonide (9 mg once daily) is effective and safe for short-term treatment of collagenous colitis. Short-term treatment with oral mesalamine (3 g once daily) appears to be ineffective. ClinicalTrials.gov number, NCT00450086.
Authors: Dora Colussi; Behzad Salari; Kathleen O Stewart; Gregory Y Lauwers; James R Richter; Andrew T Chan; Luigi Ricciardiello; Hamed Khalili Journal: Scand J Gastroenterol Date: 2015-05-21 Impact factor: 2.423
Authors: Tahir S Kafil; Tran M Nguyen; Petrease H Patton; John K MacDonald; Nilesh Chande; John Wd McDonald Journal: Cochrane Database Syst Rev Date: 2017-11-11
Authors: Andreas Münch; Curt Tysk; Johan Bohr; Ahmed Madisch; Ole K Bonderup; Ralf Mohrbacher; Ralph Mueller; Roland Greinwald; Magnus Ström; Stephan Miehlke Journal: J Crohns Colitis Date: 2015-12-30 Impact factor: 9.071