Goals: Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects. Background: To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC. Study: Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters. Results: A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P < 0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group. Conclusions: BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis. Copyright © 2005 by Lippincott Williams & Wilkins.
Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: A single-blind randomized controlled trial / Gionchetti, P.; D'Arienzo, A.; Rizzello, F.; Manguso, F.; Maieron, R.; Lecis, P. E.; Valpiani, D.; Iaquinto, G.; Annese, V.; Balzano, A.; Varoli, G.; Campieri, M.; Bennato, R.; Zilli, M.; Biedo, F. C.; Germana, B.; Bove, A.; Lombardi, G.; Pasquale, L.; Andriulli, A.; D'Albasio, G.; Bagnoli, S.; Adamo, S.; Desideri, S.; Benedetti, G.; Sablich, R.; Riegler, G.; Caserta, L.; Belletta, M.; Benedetti, A.; Ridolfi, F.; Blasi, A.; Inserra, G.; Prada, A.; Ferrau, O.; Turiano, S.; Loriga, P.; Muscas, A.; Murgia, R.; Colombo, E.; Canevelli, E.; Menardo, G.; Dagnino, F.; Monica, F.; Giordano, M.; Torelli, I.; Cuoco, D. L.; Villa, E.; Rigo, G.; Bertani, A.; Cremonini, C.; Minoli, G.; Meucci, G.; Cattoni, M.. - In: JOURNAL OF CLINICAL GASTROENTEROLOGY. - ISSN 0192-0790. - 39:4(2005), pp. 291-297. [10.1097/01.mcg.0000155124.74548.61]
Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine: A single-blind randomized controlled trial
Rizzello F.;Bove A.;Lombardi G.;Blasi A.;Prada A.;Colombo E.;Dagnino F.;Villa E.;Bertani A.;Cremonini C.;
2005
Abstract
Goals: Therapy for active ulcerative colitis (UC) usually involves rectal formulations of corticosteroids (CS), which are characterized by the risk of systemic steroid-related adverse effects. Background: To compare the efficacy and safety of the topically acting CS beclomethasone dipropionate (BDP) versus mesalamine (5-ASA) in the treatment of active UC. Study: Patients with mild to moderate distal active UC were randomized to a 6-week treatment with BDP 3 mg enema o.d. or 5-ASA 1 g enema daily in a single-blind, multicenter, parallel-group, controlled study. The primary efficacy variable was the decrease in Disease Activity Index (DAI) score. Safety variables were adrenal function, monitoring of adverse events, vital signs, and laboratory parameters. Results: A total of 217 patients were enrolled and treated with BDP (n = 111) or 5-ASA (n = 106). A significant decrease in the DAI score (P < 0.05) was observed in both treatment groups, with a clinical remission rate of 36.7% in the BDP group and of 29.2% in the 5-ASA group. Both treatments were well tolerated. No changes from baseline in morning cortisol levels were observed in the BDP group. Conclusions: BDP administered as a rectal enema over a 6-week treatment period was efficacious and safe in patients with active UC, without interference with pituitary adrenal axis. Copyright © 2005 by Lippincott Williams & Wilkins.
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