Oral beclomethasone dipropionate in patients with mild to moderate ulcerative colitis: A dose-finding study

Abstract

Systemic glucocorticosteroids have demonstrated efficacy in ulcerative colitis (UC) but cause undesired systemic side effects. Beclomethasone dipropionate (BDP) has potent topical activity and is extensively metabolized. This randomized double-blind study investigated an oral gastroresistant controlled-release preparation of BDP in 57 patients with mild to moderately severe extensive or left-sided UC. Patients were assigned to receive BDP 5 or 10 mg/d; a third group took a clinically inactive dose (1.6 g/d) of 5-aminosalicylic acid (5-ASA). Both BDP doses displayed excellent efficacy confirmed by results of endoscopy, biopsy, and clinical evaluation. Significant improvement from baseline occurred in most signs and symptoms of UC, particularly stool frequency, rectal bleeding, and mucus in the stool (P<.01). Tolerability was good in both BDP groups. Morning plasma cortisol levels decreased significantly from baseline with BDP 10 mg, but no significant changes in vital signs were observed at the end of treatment. Despite a small sample size and the open comparison with 5-ASA, this multicenter study showed the therapeutic equivalence of BDP 5 and 10 mg/d in alleviating clinical symptoms and improving endoscopic and biopsy scores in patients with mild to moderate UC. BDP 5 mg/d displayed better general tolerability and less reduction of plasma cortisol levels, however, and may be preferable to the higher dose in this indication.

A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease

“…11,31 Metabolites of BDP are systemically bioavailable, resulting in decreased adrenal responsiveness over time of drug exposure. 31,[44][45][46][47] Two recent studies of long-term use of oral, topically active corticosteroids in doses similar to those used in this trial demonstrated little evidence of clinical adrenal insufficiency. 45,48 Two randomized trials have shown that oral BDP prevents relapses of acute gastrointestinal GVHD after accelerated withdrawal of prednisone therapy.…”

Oral high dose Beclomethasone dipropionate for treatment of active ulcerative colitis

“…In previous studies, the role of rectal formulation of BDP in treatment of UC has been evaluated in comparison with 5-ASA or prednisolone sodium phosphate enemas showing similar efficacy for mild or moderate distal disease. [8][9][10][11][12][13][14][15][16][17][18] A standard dose of BDP 5 mg od (1 tablet day) has been established in the study conducted by Rizzello et al 9 In this study, administration of 5 mg or 10 mg daily showed therapeutic equivalence in patients affected by mild to moderate extensive or left-sided UC, whilst morning plasma cortisol level decreased in the 10 mg group without changes in vital signs. Oral BDP at a standard dose has been studied in treatment of active extensive or left-sided UC, either in combination with 5-ASA or alone resulting effective and safe, without signs of pituitaryadrenal function impairment.…”

“…8 For active mild or moderate extensive or left-sided UC, BDP oral preparation (5 mg tablets) is administered at the recommended dosage of 1 tablet od either in combination with 5-ASA or alone. 9 Since the tablet dissolves at pH values of less than 6.0, the oral delayed-release preparation of BDP is effective in the distal small bowel and throughout the colon. 10,11 Despite its promising characteristics and encouraging results, role of BDP in clinical practice still needs to be established.…”

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.…”