Gert Van Assche1, Francesco Manguso2, Marco Zibellini3, José Luis Cabriada Nuño4, Adrian Goldis5, Evgeniy Tkachenko6, Guido Varoli3, Dariusz Kleczkowski7, Vito Annese8, François D'Heygere9, Antonio Balzano2. 1. Department of Gastroenterology, UZ Gasthuisberg, Leuven, Belgium. 2. Division of Gastroenterology and Endoscopy, Cardarelli Hospital, Naples, Italy. 3. Corporate Clinical Development, Chiesi Farmaceutici S.p.A., Parma, Italy. 4. Hospital Galdakao, Barrio Labeaga, Vizcaya, Spain. 5. Policlinica Algomed, Centru Medical e Gastroenterologie, Medicina Interna si Nefrologie, Timisoara, Romania. 6. St Petersburg State Medical Academy n.a. I.I. Mechnikov, St Petersburg, Russia. 7. Endoskopia B. Chrobrego 6/8 81-756, Sopot, Poland. 8. Department of Gastroenterology, University Hospital Careggi, Florence, Italy. 9. Department of Gastroenterology and Hepatology, AZ Groeninge, Kortrijk, Belgium.
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.
RCT Entities:
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.
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