Xarelto: Ph III EINSTEIN CHOICE data

The double-blind, international Phase III EINSTEIN CHOICE trial in 3,365 patients with confirmed symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) who were initially treated with 6 or 12 months of anticoagulation therapy showed that once-daily 10 and 20 mg oral Xarelto for 12 months each met the primary endpoint of reducing the rate of recurrent VTE vs. aspirin (1.2% and 1.5%, respectively, vs. 4.4%, p<0.001 for both). Fatal VTE occurred in 0% and 0.2% of patients who received low- and high-dose Xarelto, respectively, vs. 0.2% of patients who received aspirin. Additionally, there was no significant difference between low- or high-dose Xarelto and aspirin in the rates of major bleeding (0.4% and 0.5%, respectively, vs. 0.3%, p=0.5 and p=0.32). Clinically relevant non-major bleeding occurred in 2% and 2.7% of patients who received low- and high-dose Xarelto, respectively, vs. 1.8% of patients who received aspirin. Data were published in The New England Journal of Medicine and presented at the American College of Cardiology meeting in Washington, D.C. EINSTEIN CHOICE is part of the EXPLORER clinical research program evaluating Xarelto in a target population of >275,000 patients. The program includes 10 indication-seeking and label expansion studies beyond the 6 indications for which the drug is approved in the U.S...