Japan-based pharmaceutical company Daiichi Sankyo Company has announced positive data from the clinical study of DU-176b, an oral anticoagulant that directly inhibits Factor Xa, a clotting factor in the blood.
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The data showed that DU-176b reduced the incidence of venous thromboembolism compared with dalteparin among patients undergoing elective unilateral hip replacement surgery. There was a statistically significant dose response in efficacy (P <0.01), and the observed bleeding rates were low across the groups. This randomized, double-blind comparative study examined the safety and efficacy of four doses of DU-176b (15, 30, 60 and 90mg once daily) versus the low molecular weight heparin, dalteparin. The study was conducted among 903 patients in Europe and North America undergoing total hip replacement surgery. Daiichi Sankyo is said to be developing DU-176b as a potential new treatment for the prevention of both arterial and venous thromboembolism. John Alexander, president of pharma development at Daiichi Sankyo, said: "We expect to commence Phase III studies for DU-176b, targeting patients with atrial fibrillation, before the end of 2008."
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