On 12 December, Daiichi Sankyo 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 than those treated with enoxaparin (5.1% vs. 10.7%, P<0.001, Relative Risk Reduction [RRR] 52.7%), an effect that was shown without a statistically significant difference in bleeding between the groups.
The analysis drew data from two randomised, double-blind, double-dummy, phase III studies (STARS E-III and STARS J-V) of 1,326 Japanese and Taiwanese patients who underwent total knee arthroplasty or total hip arthroplasty. Results were presented in an oral session at the 53rd Annual Meeting of the American Society of Hematology in San Diego, USA.
“Total hip and knee arthroplasty surgeries place patients at a higher risk of DVT, which can lead to thromboembolic disease such as pulmonary embolism,” said 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 pulmonary embolism following these surgeries.”
The incidence of major and clinically relevant non-major (CRNM) bleeding events in the edoxaban and enoxaparin groups was 4.6% vs. 3.7%, 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 randomised to receive either oral edoxaban 30 mg once daily or subcutaneous enoxaparin 20 mg (2,000 IU) twice daily for 11 to 14 days, in line with standard clinical practice in Japan.
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.