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Published on 14 December 2011

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Edoxaban reduces venous thromboembolism risk

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Edoxaban, a direct oral once-daily factor Xa inhibitor, significantly reduces the risk of developing venous thromboembolism (VTE) following total knee or hip arthroplasty when compared to enoxaparin, according to the results of a pooled analysis presented at the 2011 American Society of Haematology Annual Meeting.

Patients receiving edoxaban had a lower incidence of a composite of deep vein thrombosis (DVT) and pulmonary embo-lism (PE) than those treated with enoxaparin (5.1% vs. 10.7%, P<0.001, Relative Risk Reduction [RRR] 52.7%, Absolute Risk Reduction [ARR] -5.6%), an effect that was shown without a statistically significant difference in bleeding between the groups.

Edoxaban is licensed only in Japan for the prevention of VTE after major orthopaedic surgery, under the brand name Lixiana®.

In Europe, edoxaban has not been approved yet. Daiichi Sankyo continues to develop edoxaban at a global level as a potential new treat-ment for stroke prevention in atrial fibrillation, and the treatment and prevention of recurrent VTE.

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 had underwent total knee ar-throplasty (TKA) or total hip arthroplasty (THA).

“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 Orthopaedic 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 2050,4 it will become increasingly important for physicians to have a number of treatment options to prevent DVT and PE 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.

Edoxaban is licensed only in Japan for the prevention of VTE after major orthopaedic surgery, under the brand name Lixiana®.

In Europe, edoxaban has not been approved yet. Daiichi Sankyo continues to develop edoxaban at a global level as a potential new treat-ment for stroke prevention in atrial fibrillation, and the treatment and prevention of recurrent VTE.

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 11-14 days, in line with standard clinical practice in Japan.

Daiichi Sankyo



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