Gastroenterology

Gastroenterology

Volume 146, Issue 5, May 2014, Pages 1222-1230.e2
Gastroenterology

Original Research
Full Report: Clinical—Alimentary Tract
Budesonide Is More Effective Than Mesalamine or Placebo in Short-term Treatment of Collagenous Colitis

https://doi.org/10.1053/j.gastro.2014.01.019Get rights and content
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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

Therapy
Clinical Trial
Drug
Microscopic Colitis

Abbreviations used in this paper

AE
adverse event
CR
clinical remission
ITT
intention-to-treat
PP
per-protocol

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Conflicts of interest These authors disclose the following: Ole K. Bonderup, Ahmed Madisch, Stephan Miehlke, and Michael Vieth have received honoraria from Dr Falk Pharma GmbH; Roland Greinwald and Ralf Mohrbacher are employees of Dr Falk Pharma GmbH. All remaining authors disclose no conflicts.

Funding Supported by Dr Falk Pharma GmbH, Freiburg, Germany.