Results of phase III EINSTEIN CHOICE show patients with venous thromboembolism taking Xarelto (rivaroxaban) have reduced bleeding events- Janssen Pharma

Janssen Pharmaceuticals has announced new Phase III results from EINSTEIN CHOICE showing patients with venous thromboembolism (VTE) taking Xarelto (rivaroxaban), who received either 10 mg or 20 mg once daily over an extended time period, had significantly fewer recurrent blood clots and similar rates of major bleeding compared to those taking aspirin 100 mg once daily. Specifically, Xarelto 10 mg reduced the risk of recurrent VTE by 74 percent and Xarelto 20 mg by 66 percent.

EINSTEIN CHOICE met its primary endpoint, finding both Xarelto doses (10 mg and 20 mg) to be superior to aspirin in preventing recurrent VTE. Researchers observed that the rate of recurrent VTE was 1.2 percent in the Xarelto 10 mg group and 1.5 percent in the Xarelto 20 mg group compared to 4.4 percent in the aspirin group. Fatal VTE occurred in 0 percent, 0.2 percent and 0.2 percent, respectively. Additionally, rates of major bleeding were comparable and low across all treatment groups at 0.4 percent for Xarelto 10 mg, 0.5 percent for Xarelto 20 mg and 0.3 percent for aspirin. Rates of clinically relevant non-major bleeding also were similar between the groups at 2.0 percent, 2.7 percent and 1.8 percent, respectively. These findings were presented during a Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials session at the American College of Cardiology's 66th Annual Scientific Session and published simultaneously in The New England Journal of Medicine.

See: Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism