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* = Presenting author

P510. European multicenter trial of budesonide and mesalazine for short-term treatment of active collagenous colitis (BUC60/COC)

S. Miehlke1, A. Madisch2, L. Kupcinskas3, D. Petrauskas3, G. Heptner4, G. Böhm5, H.-J. Marks6, M. Neumeyer7, T. Nathan8, F. Fernández-Bañares9, R. Greinwald10, R. Mohrbacher10, M. Vieth11, O. Bonderup12, 1Magen-Darm-Zentrum Eppendorf, Hamburg, Germany, 2Med. Dept. I, Siloah Hospital, Hannover, Germany, 3Lithuanian University of Helath Sciences, Kaunas, Lithuania, 4Private practice, Dresden, Germany, 5Private Practice, Ludwigshafen, Germany, 6Private Practice, Siegen, Germany, 7Private Practice, Oldenburg, Germany, 8Vejle Sygehus, Denmark, 9Hospital Universitario Mutua Terrassa, Spain, 10Dr. Falk Pharma GmbH, Freiburg, Germany, 11Institute for Pathology, Klinkum Bayreuth, Germany, 12Diagnostic Center, Silkeborg Hospital, Denmark

Background

Budesonide is effective for the treatment of collagenous colitis, however previous studies were small and differed in efficacy measures. Mesalazine is regarded as an alternative treatment option although its efficacy has never been proven in placebo-controlled trials.

Methods

Patients with active collagenous colitis randomly received either budesonide capsules 9 mg/day (Budenofalk®) or mesalazine granules 3 g/day (Salofalk®) or placebo for 8 weeks in a double-blind double-dummy fashion. The primary endpoint was clinical remission (CR) at 8 weeks defined as ≤3 stools/d. Secondary endpoints included CR at 8 weeks according to the Hjortswang-Criteria of disease activity, abdominal pain and histological response.

Results

Ninety-two patients were randomized. The proportion of patients in CR at week 8 was higher with budesonide than with placebo (intention-to-treat 80.0% vs. 59.5%, p = 0.072, per protocol 84.6% vs. 60.6% p = 0.046). According to the Hjortswang-Criteria, CR was achieved in 80% with budesonide and 37.8% with placebo (p = 0.0006). Mesalamine was not better than placebo (CR 44%), but budesonide was superior over mesalazine (p = 0.0035). Budesonide significantly improved stool consistency, histology and abdominal pain. The rate of adverse events did not differ between the three treatment groups.

Conclusion

Budesonide is effective and safe for short-term treatment of collagenous colitis, while short-term treatment with mesalazine appears to be ineffective.