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| |  Budesonide Helps Maintain Remission in Patients With Collagenous Colitis: Presented at UEGW By Jill Stein PARIS, FRANCE -- October 29, 2007 -- Long-term therapy with oral budesonide controlled ileal release capsules is effective for maintaining clinical remission and is well tolerated in patients with collagenous colitis, investigators reported here at the 15th United European Gastroenterology Week (UEGW). Stephan Miehlke, PhD, Consultant, Medical Department, University Hospital, Dresden, Germany, and colleagues assessed the efficacy and safety of budesonide 6 mg/day for maintaining clinical remission in 48 patients with collagenous colitis. All subjects initially received open-label induction therapy with budesonide 9 mg (3 X 3 mg capsules) OD for 6 weeks. Clinical remission was defined as no more than three watery or loose stools per day upon completion of induction therapy. Subsequently, patients in clinical remission were randomised to double-blind treatment with budesonide 6 mg (2 X3 mg capsules) OD or placebo for 6 months (maintenance phase). Clinical remission at the end of the maintenance phase was defined as no more than three watery or loose stools per day in the previous 7 days, as determined from patient daily diaries. There were 17 clinical relapses during the maintenance treatment phase, virtually all of which occurred within the first 2 months of maintenance therapy. Overall, the cumulative rate of clinical relapse was significantly lower with budesonide maintenance therapy versus placebo (3/23 or 13% vs 14/23 or 61%, respectively, P <.0005). The proportion of patients in clinical remission at months 2, 4, and 6 was also significantly higher with budesonide versus placebo, Dr. Miehlke said in a presentation on October 29. Among evaluable patients, there was high correlation between clinical remission at the end of maintenance therapy and histological remission in 14 of 15 (93%) budesonide and six of nine (67%) placebo patients. Most patients rated the tolerability of maintenance therapy with oral budesonide a "good" or "very good", which was comparable to what was observed during the open-label induction phase. Eight (35%) patients experienced adverse events during budesonide maintenance therapy, most commonly headache and infections. No serious adverse events were reported. The results demonstrate the effectiveness and good tolerability of budesonide maintenance treatment in patients with collagenous colitis, Dr. Miehlke noted. This is important given that 60% to 80% of patients relapse once treatment is stopped. Funding for this study was provided by Astra Zeneca PLC.
[Presentation title: Budesonide for Maintenance Treatment of Collagenous Colitis - a Randomized, Double-Blind, Placebo-Controlled Trial. Abstract G-337]
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