RESEARCHERS PRESENT DATA ON BAYER'S FACTOR XA INHIBITOR

Results of Phase II studies of Bayer's rivaroxaban, an oral Factor Xa inhibitor for the treatment of deep vein thrombosis (DVT), were presented at the World Congress of Cardiology in Barcelona. The findings highlight the potential of rivaroxaban for both acute and long-term anticoagulant care. Based on these data, a Phase III trial program has been initiated.

The Phase II dose-finding trial program comprised two studies: ODIXa-DVT and EINSTEIN-DVT. The trials enrolled a total of 1,156 patients with acute, symptomatic DVT and studied doses in the range of 20 to 60 mg administered once daily in EINSTEIN-DVT and once and twice daily in ODIXa-DVT. The treatment plan was compared with a standard therapy of a parenterally administered heparin followed by an oral vitamin K antagonist for up to three months.

In ODIXa-DVT, rivaroxaban reduced clot size at 21 days and at three months with low rates of venous thromboembolism recurrence. Similar results were seen in the EINSTEIN-DVT study. Overall, the rate of recurrent DVT was low across all groups and similar across all rivaroxaban doses, and there was similar efficacy between any of the rivaroxaban doses tested and standard therapy.