Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis
Stephan Miehlke, Daniela Aust, Emese Mihaly, Peter Armerding, Günther Böhm, Ole Bonderup, Fernando Fernández-Bañares, Juozas Kupcinskas, Lars Kristian Munck, Kai-Uwe Rehbehn, Tanju Nacak, Roland Greinwald, Andreas Münch, BUG-1/LMC Study Group, Jiri Stehlk, Ole Bonderup, Lars Kristian Munck, Terje Rannem, Peter Armerding, Michael Bläker, Günter Böhm, Mark Hoesl, Christian Kirsch, Ahmed Madisch, Eberhard Meier, Stephan Miehlke, Kai-Uwe Rehbehn, Gyula G Kiss, Ferenc Nagy, Zsolt Tulassay, Ferenc Zsigmond, Limas Kupcinskas, Gerd Bouma, Marieke Pierik, Fernando Fernández-Bañares, Alfredo J Lucendo, Johan Bohr, Per Hellström, Barbro Lebrun, Greger Lindberg, Andreas Münch, Lina Vigren, Miroslav Wielondek, Martin Krauss, Axel Dignass, Wolfgang Kruis, Stephan Miehlke, Daniela Aust, Emese Mihaly, Peter Armerding, Günther Böhm, Ole Bonderup, Fernando Fernández-Bañares, Juozas Kupcinskas, Lars Kristian Munck, Kai-Uwe Rehbehn, Tanju Nacak, Roland Greinwald, Andreas Münch, BUG-1/LMC Study Group, Jiri Stehlk, Ole Bonderup, Lars Kristian Munck, Terje Rannem, Peter Armerding, Michael Bläker, Günter Böhm, Mark Hoesl, Christian Kirsch, Ahmed Madisch, Eberhard Meier, Stephan Miehlke, Kai-Uwe Rehbehn, Gyula G Kiss, Ferenc Nagy, Zsolt Tulassay, Ferenc Zsigmond, Limas Kupcinskas, Gerd Bouma, Marieke Pierik, Fernando Fernández-Bañares, Alfredo J Lucendo, Johan Bohr, Per Hellström, Barbro Lebrun, Greger Lindberg, Andreas Münch, Lina Vigren, Miroslav Wielondek, Martin Krauss, Axel Dignass, Wolfgang Kruis
Abstract
Background & aims: Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis.
Methods: Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week 8.
Results: The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P = .01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P = .09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P = .02) or placebo (21%; P = .008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group.
Conclusions: In a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.
Keywords: 5-Aminosalicylic Acid; Corticosteroid; Intraepithelial Lymphocytes; Microscopic Colitis.
Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.
Source: PubMed