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Oral Budesonide Controls Collagenous Colitis Better Than Placebo: Presented at DDW By Ed Susman SAN DIEGO -- May 23, 2008 -- Patients with collagenous colitis appear to obtain significantly better long-term relief of symptoms with oral budesonide therapy than with placebo, according to a randomised study presented here at Digestive Disease Week 2008 (DDW). Rates of clinical remission were also higher at months 2, 4, and 6 with budesonide versus placebo, said Stephan Miehlke, MD, Professor of Medicine, Technical University Hospital, Dresden, Germany, in his poster presentation on May 20. Collagenous colitis is an inflammatory bowel disease characterised by chronic, watery diarrhoea, he explained. Oral budesonide, which exerts a potent local anti-inflammatory effect due to its high affinity for glucocorticoid receptors in the gut, has been shown in previous studies to induce rapid remission of collagenous colitis in placebo-controlled studies." Dr. Miehlke and his colleagues attempted to determine if long-term treatment with budesonide could reduce a historically high relapse rate. The researchers randomly assigned 23 individuals with collagenous colitis to budesonide and 23 patients to placebo. The budesonide patients had a median age of 61 years and the placebo patients had a median age of 56 years; about three-fourths of the patients were women. At 2 months, Dr. Miehlke observed that 87% of the budesonide patients achieved remission compared with 43.5% of the placebo patients (P < .002); those figures held at 4 months (P < .002) and at 6 months, 87% of the budesonide patients remained in remission compared with 39% of the placebo patients (P < .001). "There were 17 clinical relapses during the maintenance treatment phase, virtually all of which occurred within the first 2 months of maintenance therapy," Dr. Miehlke reported. "Overall the cumulative rate of clinical relapse was significantly lower with budesonide maintenance therapy versus placebo." Of the 23 budesonide patients, 13% experienced a relapse compared with 61% of 23 placebo patients (P = .002). Funding for this study was provided by AstraZeneca Research and Development. [Presentation title: Oral Budesonide for Maintenance Treatment of Collagenous Colitis: A Randomised, Placebo-Controlled, Double-Blind Trial. Abstract T1123] E-mail this page to a friend or colleague! To print, use this version