Eliquis apixaban: Phase III data

The double-blind, international Phase III AMPLIFY-EXT trial in 2,486 patients with VTE who completed 6-12 months of prior anticoagulation therapy showed that twice-daily 2.5 and 5 mg Eliquis for 1 year each met the composite primary endpoint of reducing the incidence of symptomatic recurrent VTE or all-cause death vs. placebo (3.8% and 4.2%, respectively, vs. 11.6%, p<0.001 for both). Both doses of Eliquis also met the composite secondary endpoint of reducing the incidence of recurrent VTE or VTE-related death vs. placebo (1.7% for both low- and high-dose Eliquis vs. 8.8%, p<0.001 for both). Additionally, 2.1% of patients receiving low-dose Eliquis and 2.3% of patients receiving high-dose Eliquis experienced recurrent VTE, VTE-related death, myocardial infarction (MI), stroke or cardiovascular-related death vs. 10% for placebo. Eliquis non-significantly reduced the rate of all-cause mortality to 0.8% in the low-dose group and 0.5% in the high-dose group vs. 1.7% for placebo.

Major bleeding occurred in 0.2% of patients receiving low-dose Eliquis and 0.1% of patients receiving high-dose Eliquis vs. 0.5% for placebo. Clinically relevant non-major bleeding occurred in 3% of patients receiving low-dose Eliquis and 4.2% of patients receiving high-dose Eliquis vs. 2.3% for placebo. Data were published in the New England Journal of Medicine and presented at the American Society of Hematology meeting in Atlanta. ...