A new study conducted by an international research team recently revealed that the corticosteroid, beclomethasone dipropionate (BDP), can be successfully employed as a treatment strategy for patients with active mild-to-moderate ulcerative colitis. The study was published in The American Journal of Gastroenterology and is entitled “Oral Prolonged Release Beclomethasone Dipropionate and Prednisone in the Treatment of Active Ulcerative Colitis: Results From a Double-Blind, Randomized, Parallel Group Study.”
Ulcerative colitis is a type of chronic inflammatory bowel disease (IBD) characterized by inflammation in the colon, formation of ulcers (tiny open sores), abdominal discomfort and diarrhea with blood. Ulcerative colitis is thought to be the result of an abnormal response by the body’s immune system.
Prednisone is a synthetic corticosteroid drug that has immunosuppressive properties and is often employed in the treatment of inflammatory conditions such as ulcerative colitis. It can, however, induce significant adverse effects. BDP is a potent corticosteroid drug designed to prevent and control asthma symptoms; it is also licensed for ulcerative colitis treatment in conjunction with 5-aminosalicylates, the first line therapy for achieving and maintaining remission of IBD.
In this study, researchers compared the safety and efficacy of BDP to prednisone in 282 patients suffering from active, mild-to-moderate ulcerative colitis not responsive to 5-aminosalicyilic acids. The study was conducted at 39 European centers between September 2007 and December 2008. Patients either received BDP-prolonged release 5 mg tablets (Clipper tablets, Chiesi Pharmaceuticals), once daily for 4 weeks and then every other day for an additional 4 weeks, or oral prednisone at 40 mg, once daily for 2 weeks and then tapered of 10 mg every 2 weeks during the 8-week study period. Researchers evaluated patients in terms of their Disease Activity Index (DAI).
The team found that after 4 weeks of treatment, DAI response rates were 64.6% in patients receiving BDP and 66.2% in the prednisone group, suggesting that BDP is not inferior in terms of efficacy compared to prednisone. Both treatments had an overall good safety profile with 38.7% of the patients in the BDP group and 46.9% in the prednisone group experiencing steroid-related adverse effects.
The team concluded that both oral prolonged release BDP and prednisone are effective therapies for mild-to-moderate ulcerative colitis treatment.
“No safety signals in both groups were detected concerning vital signs and hematochemical parameters,” wrote the research team according to a news release. “In conclusion, this first study comparing oral controlled-release BDP vs. systemic [prednisone] in active UC [ulcerative colitis] confirms the efficacy of both the treatment strategies for the induction of clinical and endoscopic improvement, with a positive safety profile if [prednisone] is early tapered.”