Oral beclometasone dipropionate in the treatment of extensive and left‐sided active ulcerative colitis: a multicentre randomised study

Abstract

SUMMARYAim: To explore the efficacy and safety of the topically acting steroid beclometasone dipropionate (BDP) in an oral controlled release formulation in the treatment of extensive or left-sided ulcerative colitis. Methods: In a multicentre, randomised, parallel-group, single-blind study, patients with active mild to moderate ulcerative colitis were randomised to a 4-week treatment with BDP 5 mg/day o.d. vs. 5-ASA 0.8 g t.d.s. The primary efficacy variable was the decrease of Disease Activity Index (DAI) (clinical symptoms and endoscopic appearance of mucosa). Safety was evaluated by monitoring adverse events, vital signs, haematochemical parameters and adrenal function.Results: One hundred and seventy-seven patients were enrolled and randomly treated with BDP (n ¼ 90) or 5-ASA (n ¼ 87). Mean DAI score decreased in both treatments groups (P < 0.0001 vs. baseline for both groups). Clinical remission was achieved in 63.0% of patients in the BDP group vs. 62.5% in the 5-ASA group. A significant DAI score improvement (P < 0.05) in favour of BDP was observed in patients with extensive disease. Both treatments were well tolerated. Mean plasma cortisol levels were significantly reduced vs. baseline in BDP recipients, but without signs of pituitary-adrenal function depletion. Conclusion: Oral BDP gave an overall treatment result in patients with active ulcerative colitis without signs of systemic side-effects.

Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis

“…An oral controlled-release form of beclomethasone diproprionate has also been studied; however, this showed only comparable efficacy with mesalazine and plasma cortisol levels were suppressed. 22 This study used VAS to measure the primary end points. VAS have been widely and successfully used in the evaluation of subjective measures such as quality of life, 23 pain 24 and depression.…”

Recent advances in the management of distal ulcerative colitis

“…Oral beclomethasone diproprionate in combination with oral 5-ASA has been found to be significantly more effective than 5ASA alone in the treatment of patients with extensive or left-sided active UC [46] . In another large study of patients with active left-sided or extensive colitis, beclomethasone diproprionate 5 mg/d had an effect similar to that of mesalazine, but without systemic steroid side-effects [47] . Beclomethasone diproprionate has also been used in an enema with comparable tolerability and efficacy to mesalazine enema in mild active distal UC [48] .…”

Second-Generation Corticosteroids for the Treatment of Crohn’s Disease and Ulcerative Colitis: More Effective and Less Side Effects?

“…Oral BDP is effective in improving clinical, endoscopic and biopsy scores in patients with mild-to-moderate left-sided and extensive UC [58,59,60,61,62]. The efficacy of BDP is higher when associated with mesalazine products [59], and was equivalent to oral prednisone in the BETA study [unpubl.…”