Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced the results of the six month Phase 3 AMPLIFY trial of 5,395 patients with acute venous thromboembolism (VTE), which includes symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE). In this trial, Eliquis as a single-agent achieved the primary efficacy endpoint of noninferiority to current standard of care (initial parenteral enoxaparin treatment overlapped with warfarin therapy) in the reduction of the composite endpoint of recurrent symptomatic VTE or VTE-related death.
Eliquis also met the primary safety endpoint of superiority for major bleeding, with a 69 percent relative risk reduction (RRR) compared to current standard of care.
Importantly, AMPLIFY demonstrated comparable results for the primary efficacy and safety endpoints between patients entering the study with a DVT or a PE.
The findings were published online in
New England Journal of Medicine
and announced at the 24th Congress of the International Society on Thrombosis and Haemostasis (ISTH).
Venous thromboembolism, or VTE, encompasses two serious conditions: deep vein thrombosis (DVT), a blood clot in a vein, usually in the leg, that partially or totally blocks the flow of blood; and pulmonary embolism (PE), a blood clot blocking one or more vessels in the lungs. VTE continues to be a major cause of morbidity and mortality, with approximately 900,000 patients in the U.S. and approximately 1 million patients in the EU diagnosed every year. Once a VTE has occurred, up to 10 percent of people may have a VTE reoccurrence, which could potentially be fatal.
“The study results showed that apixaban, as a single-agent, has comparable efficacy with significantly fewer major bleeding events with respect to the standard of care. These results complement the previously published results for the AMPLIFY-EXT study,” said Dr. Giancarlo Agnelli, professor of internal medicine, University of Perugia, Italy; director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit, University Hospital, Perugia, Italy; and lead investigator of the study. “Together these studies represent exciting data in the field of VTE treatment and indicate that apixaban may offer an important potential alternative in both acute and extended anticoagulation therapy for VTE patients.”