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Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study.
- Source :
-
American Journal of Gastroenterology (Springer Nature) . May2015, Vol. 110 Issue 5, p708-715. 8p. 1 Diagram, 4 Charts, 3 Graphs. - Publication Year :
- 2015
-
Abstract
- OBJECTIVES:Double-blind study comparing efficacy and safety of the topically acting corticosteroid beclomethasone dipropionate (BDP) to prednisone (PD) in patients with active, mild-to-moderate ulcerative colitis (UC).METHODS:Overall, 282 patients were randomized to receive BDP-prolonged release tablets 5 mg once daily for 4 weeks and then every other day for an additional 4 weeks or oral PD 40 mg once daily for the initial 2 weeks tapered of 10 mg every 2 weeks during the 8-week study period. Efficacy end point was the non-inferiority of BDP vs. PD in terms of Disease Activity Index (DAI) score <3 or reduction by at least 3 points for patients with a baseline DAI ≥7 at week 4. Safety end point was the proportion of patients with steroid-related adverse events (AEs) and cortisol <150 nmol/l at week 4.RESULTS:DAI response rates at week 4 were 64.6% and 66.2% with BDP and PD, respectively, demonstrating non-inferiority of BDP vs. PD (delta: −1.56; 95% confidence interval (CI) −13.00-9.88, P=0.78). Patients with steroid-related AEs and cortisol <150 nmol/l at week 4 were 38.7% in the BDP group and 46.9% in the PD group (P=0.17 between groups). No safety signals were observed in both the groups.CONCLUSIONS:BDP was non-inferior to PD in the treatment of active UC, with a good safety profile in both the groups. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00029270
- Volume :
- 110
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- American Journal of Gastroenterology (Springer Nature)
- Publication Type :
- Academic Journal
- Accession number :
- 102450756
- Full Text :
- https://doi.org/10.1038/ajg.2015.114