Please use this identifier to cite or link to this item:
10.1111/j.1365-2036.2006.02743.x
Title: | Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis |
Authors: | 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. |
Keywords: | 3.2 Clinical medicine;1.1. Scientific article indexed in Web of Science and/or Scopus database;Hepatology;Gastroenterology;Pharmacology (medical) |
Issue Date: | Jan-2006 |
Citation: | 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 , vol. 23 , no. 2 , pp. 303-312 . https://doi.org/10.1111/j.1365-2036.2006.02743.x |
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. |
DOI: | 10.1111/j.1365-2036.2006.02743.x |
ISSN: | 0269-2813 |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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Budesonide_foam_versus_budesonide_enema.pdf | 139.21 kB | Adobe PDF | View/Open |
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