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The second study, in patients after major orthopedic surgery, continues to enroll patients, with the last patient expected to enroll around the end of the first quarter of 2013, and data expected in the second quarter.
TOKYO, July 12, 2010 /PRNewswire/ -- Daiichi Sankyo Company, Limited announced that its investigational once-daily oral, direct factor Xa inhibitor, edoxaban, was shown to be superior to enoxaparin in preventing venous thromboembolic (VTE) events in patients following total knee replacement (TKR), a type of major orthopedic surgery.
One of these, rivaroxaban, also approved in Canada and Europe, showed efficacy in prevention of venous thromboembolism after major orthopedic surgery (N.
Fondaparinux has been tested for the prophylaxis of major orthopedic surgery.
html Epidemiology: Major Orthopedic Surgery - On the rise as the global elderly population continues to grow.
Commenting on receiving the first national marketing authorization for edoxaban, Joji Nakayama, president and CEO of Daiichi Sankyo, said, "We are pleased to confirm that an exciting milestone has been reached, and we are confident that edoxaban will make a great contribution to VTE prevention after major orthopedic surgery.
Background The incidence of objectively confirmed deep venous thrombosis in hospitalized patients is at least 10% in general medical and surgical patients and as high as 60% after major orthopedic surgery.
The follow-up analysis of three recently completed international clinical studies on short-term venous thromboembolism (VTE) protective medicine in patients undergoing major orthopedic surgery demonstrated that the ultra-low-molecular-weight heparin semuloparin reduced the incidence of VTE and all-cause death by 25 per cent compared to the commonly used therapy drug enoxaparin (a low-molecular-weight heparin).