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The First Oral Factor Xa Inhibitor Xarelto? Launched in China -2

Post Time:2009-06-27 [Large Middle Small] View:
“The current anticoagulants for major orthopaedic surgery are Low-molecular-weight Heparin and Warfarin. Compared with unfractionated heparin, low molecular weight heparin is more effective and safe, but it is for subcutaneous injection and also has the possibility of a heparin-induced thrombocytopenia. Although warfarin is oral and cheap, but it has the narrow therapeutic window,and high risk of bleeding, and needs regular blood monitoring.”
“Xarelto? is an ideal anticoagulant, oral, once daily, no need for monitoring, no need for adjustment and low risk of food interactions. So it is very simple and safe,” said Prof. Ruan Changgeng. “Xarelto? targets factor Xa, a pivotal point of the blood coagulation cascade.”
RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program, a set of international multicenter randomized, double-blinded, positive controlled, phase III clinical trials involving more than 12,500 patients from 39 countries demonstrated the superior efficacy of Xarelto? in prevention of VTE (venous thromboembolism) after total hip or knee replacement surgery, reducing the composite of symptomatic VTE and all-cause mortality during the 2-week active controlled period by 56 percent compared with enoxaparin whilst maintaining a similar safety profile.
“Bayer has paid attention to the unmet medical need in the field of anticoagulation for many years. After years of efforts, we are glad to see that Xarelto has been approved in many countries including China. With the availability of Xarelto, we provide doctors and patients an effective and uncomplicated solution to prevent venous thromboembolism, which can be life-threatening,” said Dr. Jean-Philippe Milon, Head of Business Unit General Medicine, Bayer Schering Pharma AG.
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