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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. | LitMetric

AI Article Synopsis

  • A double-blind study compared the effectiveness and safety of beclomethasone dipropionate (BDP) versus prednisone (PD) in treating mild-to-moderate ulcerative colitis (UC).
  • 282 patients received either BDP or PD over an 8-week period to measure changes in disease activity.
  • Results showed that BDP was as effective as PD in reducing disease activity, with similar safety profiles for both treatments, indicating BDP is a viable alternative to PD for UC patients.

Article 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.

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Source
http://dx.doi.org/10.1038/ajg.2015.114DOI Listing

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