Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis

V. Gross, S. Bar-Meir, A. Lavy, O. Mickisch, Z. Tulassay, L. Pronai, L. Kupcinskas, G. Kiudelis, J. Pokrotnieks, Á Kovács, M. Faszczyk, A. Razbadauskas, B. Margus, M. Stolte, R. Müller, R. Greinwald

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Abstract

Background: Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis. Aim: To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema. Methods: Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index >4 and endoscopic index ≥4) were eligible for this double-blind, double-dummy, randomized, multicentre study. They received 2 mg/25 mL budesonide foam and placebo enema (n = 265), or 2 mg/100 mL budesonide enema and placebo foam (n = 268) for 4 weeks. Primary endpoint was clinical remission (clinical activity index ≤4) at the final/withdrawal visit (per protocol). Results: A total of 541 patients were randomized - 533 were evaluable for intention-to-treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (P = 0.02362 for non-inferiority of foam vs. enema within a predefined non-inferiority margin of 15%). Both formulations were safe and no drug-related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%). Conclusion: Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.

Original languageEnglish
Pages (from-to)303-312
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume23
Issue number2
DOIs
Publication statusPublished - Jan 1 2006

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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    Gross, V., Bar-Meir, S., Lavy, A., Mickisch, O., Tulassay, Z., Pronai, L., Kupcinskas, L., Kiudelis, G., Pokrotnieks, J., Kovács, Á., Faszczyk, M., Razbadauskas, A., Margus, B., Stolte, M., Müller, R., & Greinwald, R. (2006). Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis. Alimentary Pharmacology and Therapeutics, 23(2), 303-312. https://doi.org/10.1111/j.1365-2036.2006.02743.x