Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis

Autor:	Juris Pokrotnieks, Müller R, V. Gross, Ágota Kovács, A Razbadauskas, M. Faszczyk, Limas Kupčinskas, O Mickisch, Laszlo Pronai, Simon Bar-Meir, Roland Greinwald, A. Lavy, Zsolt Tulassay, Manfred Stolte, Gediminas Kiudelis, B Margus
Rok vydání:	2006
Předmět:	Budesonide Adult Male medicine.medical_specialty Adolescent medicine.drug_class medicine.medical_treatment Anti-Inflammatory Agents Enema Proctosigmoiditis Placebo Proctocolitis Gastroenterology Double-Blind Method Administration Rectal Internal medicine medicine Humans Pharmacology (medical) Proctitis Aged Intention-to-treat analysis Hepatology business.industry Middle Aged medicine.disease digestive system diseases Treatment Outcome Tolerability Patient Satisfaction Corticosteroid Colitis Ulcerative Female business medicine.drug
Zdroj:	Alimentary pharmacologytherapeutics. 23(2)
ISSN:	0269-2813
Popis:	Summary 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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d2a342d5d2246375b66caea1201e2217 https://pubmed.ncbi.nlm.nih.gov/16393311 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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