Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis
Stephan Miehlke, Ahmed Madisch, Limas Kupcinskas, Dalius Petrauskas, Günter Böhm, Hans-Joachim Marks, Michael Neumeyer, Torben Nathan, Fernando Fernández-Bañares, Roland Greinwald, Ralf Mohrbacher, Michael Vieth, Ole K Bonderup, BUC-60/COC Study Group, Matthias Andersen, Hans-Peter Bartram, Elke Bästlein, Günter Böhm, Christian Haferland, Gerhard Heptner, Dietrich Hüppe, Vassilios Kardalinos, Heinz-Jürgen Krammer, Wilfred Landry, Albin Lütke, Hans-Joachim Marks, Stephan Miehlke, Moritz Müser, Michael Neumeyer, Kai-Uwe Rehbehn, Thomas Schäfer, Gerfried Vogel, Søren Avnstrøm, Ole Bonderup, Henning Glerup, Óli Jacobsen, Torben Knudsen, Torben Nathan, Terje Rannem, Limas Kupcinskas, Fernando Fernández-Banares, Javier P Gisbert, Anthony Shonde, Walter Lehmacher, Volker Groß, Wolfgang Kruis, Stephan Miehlke, Ahmed Madisch, Limas Kupcinskas, Dalius Petrauskas, Günter Böhm, Hans-Joachim Marks, Michael Neumeyer, Torben Nathan, Fernando Fernández-Bañares, Roland Greinwald, Ralf Mohrbacher, Michael Vieth, Ole K Bonderup, BUC-60/COC Study Group, Matthias Andersen, Hans-Peter Bartram, Elke Bästlein, Günter Böhm, Christian Haferland, Gerhard Heptner, Dietrich Hüppe, Vassilios Kardalinos, Heinz-Jürgen Krammer, Wilfred Landry, Albin Lütke, Hans-Joachim Marks, Stephan Miehlke, Moritz Müser, Michael Neumeyer, Kai-Uwe Rehbehn, Thomas Schäfer, Gerfried Vogel, Søren Avnstrøm, Ole Bonderup, Henning Glerup, Óli Jacobsen, Torben Knudsen, Torben Nathan, Terje Rannem, Limas Kupcinskas, Fernando Fernández-Banares, Javier P Gisbert, Anthony Shonde, Walter Lehmacher, Volker Groß, Wolfgang Kruis
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.
Keywords: Clinical Trial; Drug; Microscopic Colitis; Therapy.
Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.
Source: PubMed