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The FDA approved the 10 mg once-daily dose of rivaroxaban (Xarelto) for patients who have taken at least 6 months of anticoagulation, .

Approval was based on the EINSTEIN CHOICE study in which both 20-mg and 10-mg doses of rivaroxaban beat aspirin in reducing a patient's risk of recurrent venous thromboembolism (VTE) -- by 66% and 74%, respectively -- without an elevated bleeding risk.

The 3,396-patient trial was presented as a late-breaker at the American College of Cardiology meeting this year. "This is a useful and safe clinical pathway for managing these patients," the presenter said at the time. There is "really no role for aspirin in this setting ... I hope these findings will encourage more physicians to prescribe rivaroxaban for these patients."

Rivaroxaban is to be prescribed at 15 mg twice daily in the first 21 days after a VTE occurrence, followed by 20 mg once daily up to the 6-month mark. With this new approval, physicians can then start patients on a 10 mg once-daily regimen if they are at continued risk for deep vein thrombosis and pulmonary embolism.

Recurrent VTE is a quality marker used by Medicare.

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