Clinical trial: Preliminary efficacy and safety study of a new Budesonide-MMX® 9 mg extended-release tablets in patients with active left-sided ulcerative colitis

G. R. D'Haens, Á Kovács, P. Vergauwe, F. Nagy, T. Molnár, Y. Bouhnik, W. Weiss, H. Brunner, A. Lavergne-Slove, D. Binelli, A. F.D. Di Stefano, P. Marteau

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59 Citations (Scopus)

Abstract

Background: Ulcerative colitis (UC) is a chronic inflammatory disease with relapses. Many patients need systemic corticosteroids to induce clinical remission. Aim: Efficacy and safety of Budesonide-MMX® 9 mg tablets, a new oral, extended-release formulation, were evaluated in patients suffering from active, left-sided UC with colitis activity index (CAI) < 14. Methods: 36 patients were treated once daily for 4 weeks with Budesonide-MMX® 9 mg tablets or placebo. In an additional 4-week period, all patients received Budesonide-MMX®. CAI, endoscopic index and histology were assessed after 4 and 8 weeks. Primary end-point was remission, and/or CAI reduction by 50% after 4 weeks. Morning cortisol was assayed after 4 and 8 weeks, and a short ACTH-test was performed at week 8. Results: 32 patients were analysed. After 4 weeks, 47.1% of the patients in the Budesonide-MMX® 9 mg tablets group achieved the primary end-point vs. 33.3% of patients on placebo. In addition, 47.1% of budesonide patients and another 33.3% of placebo recipients improved without remission by 4 weeks. The CAI reduction was significant with Budesonide (p < 0.0001) tablets and not with placebo (p = 0.1). Neither morning cortisol nor pituitary-adrenal axis was more frequently suppressed with Budesonide tablets than with placebo. Conclusions: Budesonide-MMX® 9 mg tablets induced a fast and significant clinical improvement of active left-sided UC without suppression of adrenocortical functions and without important toxicity EudraCT number 2004-000896-33.

Original languageEnglish
Pages (from-to)153-160
Number of pages8
JournalJournal of Crohn's and Colitis
Volume4
Issue number2
DOIs
Publication statusPublished - Jun 1 2010

Keywords

  • Budesonide
  • CAI
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

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