OREANDA-NEWS. December 13, 2011. Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the results of a pooled analysis showing that edoxaban, a direct oral once-daily factor Xa inhibitor, significantly reduced the risk of developing venous thromboembolism (VTE) following total knee or hip arthroplasty, when compared to enoxaparin. Patients receiving edoxaban had a lower incidence of a composite of deep vein thrombosis (DVT) and pulmonary embolism (PE) than those treated with enoxaparin (5.1 percent vs. 10.7 percent, P<0.001, Relative Risk Reduction [RRR] 52.7 percent), an effect that was shown without a statistically significant difference in bleeding between the groups.

The analysis drew data from two randomized, double-blind, double-dummy, Phase III studies (STARS E-IIIi and STARS J-Vii ) of 1,326 Japanese and Taiwanese patients who underwent total knee arthroplasty (TKA) or total hip arthroplasty (THA). Results were presented in an oral session at the 53rd Annual Meeting of the American Society of Hematology in San Diego, USA.iii

"Total hip and knee arthroplasty surgeries place patients at a higher risk of DVT, which can lead to thromboembolic disease such as PE,” said Dr. Takeshi Fuji, Head of Orthopedic Surgery, Osaka Koseinenkin Hospital, Osaka, Japan. “As the number of these surgeries increases, and the incidence of VTE is expected to double by the year 2050, it will become increasingly important for physicians to have a number of treatment options to prevent DVT and PE following these surgeries.”iv

The incidence of major and Clinically Relevant Non-Major (CRNM) bleeding events in the edoxaban and enoxaparin groups was 4.6 percent vs. 3.7 percent, respectively (P=0.427). A further subgroup analysis of major and CRNM bleeding indicated no significant difference between edoxaban and enoxaparin in any of the patient subgroups evaluated, based on age, weight, or creatinine clearance.

Patients enrolled in the STARS E-III (Japanese and Taiwanese patients) and STARS J-V (Japanese patients) studies were randomized to receive either oral edoxaban 30 mg once daily or subcutaneous enoxaparin 20 mg (2000 IU) twice daily for 11 to 14 days, in line with standard clinical practice in Japan.i, ii

“We are pleased to see positive outcomes with edoxaban in this patient population,” said Dr. Kazunori Hirokawa, Global Head of R&D Unit, Daiichi Sankyo Co., Ltd. “These results further support the safety and efficacy of edoxaban in the prevention of DVT and PE following major orthopedic surgery. Daiichi Sankyo remains committed to developing edoxaban in our global clinical trials program.”

About Edoxaban

Edoxaban is a once-daily oral anticoagulant that directly inhibits Factor Xa, an important factor in the coagulation process. Edoxaban is currently available only in Japan, licensed for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty, total hip arthroplasty and hip fracture surgery. Daiichi Sankyo continues to develop edoxaban at a global level as a potential new treatment for stroke prevention in atrial fibrillation, and the treatment and prevention of recurrent VTE. Notably, Daiichi Sankyo has more than 25 years experience conducting research in the area of Factor Xa inhibition and was the first company to study these compounds in humans.