ORAL BUDESONIDE IS AS EFFECTIVE AS ORAL PREDNISOLONE IN ACTIVE CROHNS-DISEASE

Citation
M. Campieri et al., ORAL BUDESONIDE IS AS EFFECTIVE AS ORAL PREDNISOLONE IN ACTIVE CROHNS-DISEASE, Gut, 41(2), 1997, pp. 209-214
Citations number
21
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Gastroenterology & Hepatology
Journal title
GutACNP
ISSN journal
0017-5749
Volume
41
Issue
2
Year of publication
1997
Pages
209 - 214
Database
ISI
SICI code
0017-5749(1997)41:2<209:OBIAEA>2.0.ZU;2-Q
Abstract
Background-The use of corticosteroids in active Crohn's disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass live r metabolism. Aims-To compare the efficacy and safety of two dosage re gimens of budesonide and prednisolone in patients with active Crohn's disease affecting the ileum and/or the ascending colon. Patients and m ethods-One hundred and seventy eight patients were randomised to recei ve budesonide controlled ileal release (CIR) capsules 9 mg once daily or 4.5 mg twice daily, or prednisolone tablets 40 mg once daily. The t reatment period was 12 weeks. The primary efficacy variable was clinic al remission, defined as a Crohn's Disease Activity Index (CDAI) of 15 0 or less. Results-After eight weeks of treatment, remission occurred in 60% of patients receiving budesonide once daily or prednisolone and in 42% of those receiving budesonide twice daily (p=0.062). The prese nce of glucocorticoid associated side effects was similar in all group s; however, moon face was more common in the prednisolone group (p=0.0 005). The highest frequency of impaired adrenal function, as measured by a short ACTH test, was found in the prednisolone group (p=0.0023). Conclusions-Budesonide CIR, administered at 9 mg once daily or 4.5 mg twice daily, is comparable to prednisolone in inducing remission in ac tive Crohn's disease. The single dose administration is as promptly ef fective as prednisolone and represents a simpler and safer therapeutic approach, with a considerable reduction in side effects.