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Edoxaban Significantly Reduces Risk of Venous Thromboembolism by Half Compared to Enoxaparin in Japanese and Taiwanese Patients Following Knee or Hip Arthroplasty Surgery
Date:12/12/2011

oxaban 30 mg once daily and enoxaparin 20 mg (2,000 IU) in the prevention of VTE in 610 Japanese patients undergoing THA[ii].

Both studies supported the March 2010 edoxaban New Drug Application (NDA) in Japan seeking approval for the prevention of VTE after major orthopedic surgery. In the studies, edoxaban was initiated six to 24 hours after surgery; enoxaparin was initiated 24 to 36 hours after surgery, the standard of care in Japan. The primary efficacy outcome in both studies was the composite of symptomatic and asymptomatic DVT and PE. The principal safety outcome was incidence of major and clinically relevant non-major bleeding.

About Venous Thromboembolism (VTE)
VTE is the term for the generation of a blood clot within a vein, or the subsequent breaking off of that clot into a pulmonary (lung) artery. Deep vein thrombosis (DVT) and pulmonary embolism (PE) are the two sub-types of VTE. DVT is a blood clot anywhere in the deep veins of the legs, pelvis or arms. PE is a clot that detaches from the vein and travels to the lungs, lodging in the pulmonary arteries causing a potentially fatal condition. PE is often accompanied by DVT and a DVT can develop into a PE suddenly.

Patients with diagnosed VTE are treated for three to six months (and sometimes even longer) based on their individual risk profile to prevent a second (recurrent) DVT or PE. VTE is the cause of significant mortality; 30 percent of people with VTE die within one month of diagnosis and about 25 percent of those with PE experience sudden death. Additionally, about 30 percent of those affected will experience a recurrence of DVT/PE within 10 years of the initial DVT/PE diagnosis.[v]

About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its port
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SOURCE Daiichi Sankyo Company, Limited
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2. Daiichi Sankyo Receives First Market Approval in Japan for LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, for the Prevention of Venous Thromboembolism after Major Orthopedic Surgery
3. Daiichi Sankyo Launches LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, in Japan for the Prevention of Venous Thromboembolism after Major Orthopedic Surgery
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