TOKYO and SAN DIEGO, Dec. 12, 2011 /PRNewswire/ -- 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-III[i] and STARS J-V[ii]) 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