PharmaTimes has reported on the results of a Phase III study comparing the investigational anticoagulant edoxaban to enoxaparin in the prevention of venous thromboembolism (VTE) following total hip replacement (THR) surgery, presented at the American Society of Haematology (ASH) annual meeting.
 

The Phase III STARS J-V study randomised 610 patients undergoing THR to treatment with the oral direct factor Xa inhibitor edoxaban (30mg daily) or subcutaneous injections of enoxaparin (20mg twice daily) for 11-14 days.  Asymptomatic deep vein thrombosis (DVT) occurred in 2.4% of patients randomised to edoxaban and in 6.9% of patients receiving enoxaparin (no statistical details provided).  There were no cases of pulmonaray embolism reported, and no statistically significant difference in bleeding rates between treatments (no further details provided).  More patients in the enoxaparin group experienced elevations in serum aminotransferase levels to greater than three times the upper limit of normal (10% versus 2.6%).

The report notes that edoxaban is also currently being investigated in a Phase III study compared to warfarin, in the prevention of stroke and systemic embolic events in patients with atrial fibrillation.  This study will involve 21,107 subjects at nearly 1,400 clinical trial sites.