Results from the phase III STARS J-V ( Studying Thrombosis After Replacement Surgery ) study have shown Edoxaban ( Lixiana ), a direct factor Xa inhibitor, to be superior to Enoxaparin ( Lovenox ) in preventing venous thromboembolism ( VTE ) in patients following total hip replacement ( THR ), a type of major orthopedic surgery.
This multicentre, double-blind, double dummy, centrally randomised trial evaluated the efficacy and safety of Edoxaban compared with Enoxaparin sodium in patients undergoing THR in Japan. A total of 610 patients received either 30 mg once-daily oral dose of Edoxaban or subcutaneous injection of Enoxaparin sodium 2,000 international units ( equivalent to 20 mg ) twice-daily for 11 to 14 days.
The primary efficacy endpoint of the trial was the incidence of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. The primary safety endpoint was the incidence of major bleeding and clinically relevant non-major bleeding.
Deep vein thrombosis occurred in 2.4% of patients receiving Edoxaban once-daily compared with 6.9% of patients who received Enoxaparin sodium ( relative risk reduction of 65.7%; p=0.016 ). There were no pulmonary embolism events observed in either treatment group. There was no statistically significant difference in major and clinically relevant non-major bleeding ( p=0.475 ). There were no cases of intracranial hemorrhage or death in either treatment group.
Indicators for potential liver damage in both treatment groups were carefully monitored during this trial by measuring bilirubin and serum aminotransferase levels. Elevations greater than three times the upper limit of the normal range of serum aminotransferase levels occurred in 2.6% of patients taking Edoxaban compared with 10% of those taking Enoxaparin sodium.
Source: 52nd Annual Meeting of the American Society of Hematology ( ASH ), 2010