Gross, V and Andus, T and Caesar, I and Bischoff, SC and Lochs, H and Tromm, A and Schulz, HJ and Bar, U and Weber, A and Gierend, M and Ewe, K and Scholmerich, J and Adam, B and Bauerle, H and Goebell, H and Hoffmann, R and Jakob, G and Junge, U and LorenzMeyer, H and Manns, MP and May, B and Malchow, H and Riemann, JF and Schmidt, C and Seifert, E and Tillinger, W and Vogelsang, H and Wordehoff, D (1996) Oral pH-modified release budesonide versus 6-methylprednisolone in active Crohn's disease. EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY, 8 (9). pp. 905-909. ISSN 0954-691X,
Full text not available from this repository.Abstract
Objective: Corticosteroids are effective in acute Crohn's disease (CD). The present study assessed the effectiveness and safety of oral pH-modified release budesonide (BUD) in patients with active CD in comparison with 6-methylprednisolone (MPred). Design: This was a prospective multicentre, randomized, double-blind, double-dummy study. Methods: A total of 67 patients with active CD (CDAI > 150) were included. Patients were treated with 3 x 3 mg BUD (n = 34) or MPred (n = 33) according to a weekly tapering schedule (48-32-24-20-16-12-8 mg). The primary aim was remission of CD (CDAI < 150 and decrease by at least 60 points from baseline) after eight weeks. Results: Baseline demographics, disease activity and localization of CD in the small bowel and the colon were similar in both treatment groups. On an intention-to-treat basis 19/34 patients in the BUD group (55.9%) and 24/33 patients in the MPred group (72.7%) were in remission after eight weeks (P = 0.237). Therapy failed in 15/34 patients (44.1%) of the BUD group and in 9/33 patients (27.3%) of the MPred group. The mean CDAI decreased from 262 +/- 50 to 118 +/- 69 in the BUD-group and from 262 +/- 81 to 95 +/- 61 in the Mored group (P = 0.183, final CDAI BUD vs. MPred). Steroid-related side effects appeared in 28.6% of the patients in the BUD group and in 69.7% of the patients in the Mored group (P = 0.0015). Conclusions: Oral pH-modified release budesonide (3 x 3 mg/day) is almost as effective as a conventional corticosteroid in patients with active CD but causes significantly less corticosteroid-related side effects.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DISTAL ULCERATIVE-COLITIS; DRUG-TREATMENT; PREDNISOLONE; Crohn's disease; corticosteroids; budesonide |
| Depositing User: | Dr. Gernot Deinzer |
| Last Modified: | 19 Oct 2022 08:35 |
| URI: | https://pred.uni-regensburg.de/id/eprint/51501 |
Actions (login required)
 |
View Item |
