Bristol-Myers Squibb and Pfizer announced the results of the Phase 3 AMPLIFY-EXT trial, which evaluated treatment with Eliquis (apixaban) over a one-year period compared to placebo for the prevention of recurrent venous thromboembolism (VTE) in patients who had already completed 6–12 months of anticoagulation treatment for VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE). Eliquis is an oral direct Factor Xa inhibitor.
AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY–EXTended Treatment) was a randomized, double-blind, multicenter trial that included 2,486 patients. Patients were randomized to receive either Eliquis 2.5mg or 5mg, or placebo twice daily for 12 months.
The primary efficacy outcome was the combined endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) and death from any cause. Death was classified as VTE-related, cardiovascular-related, due to bleeding, or due to other causes. For the primary efficacy outcome, Eliquis demonstrated superiority vs. placebo (11.6% in the placebo group, compared with 3.8% and 4.2% in the Eliquis 2.5mg and 5mg groups, respectively, P<0.001).