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news.Bristol-Myers Squibb Company and Pfizer have announced positive data from Eliquis (apixaban) for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapy (AMPLIFY) study.
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The study compared Eliquis as a single-agent against compared to current standard of care in 5,395 patients with confirmed symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) requiring treatment for six months.
Eliquis was non-inferior in reducing the composite endpoint of recurrent symptomatic VTE or VTE-related death to current standard of care for treatment of both symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) conditions, meeting the primary efficacy endpoint.
Meeting the primary safety endpoint, patients on Eliquis demonstrated 69% relative risk reduction (RRR) for major bleeding compared to current standard of care
The study lead investigator, University Hospital, Perugia, Italy, the Department of Internal and Cardiovascular Medicine and Stroke-Unit director, University of Perugia, Italy University of Perugia, Italy professor Dr Giancarlo Agnelli said, "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."
A total of 59 patients in the Eliquis group (2.3%) and 71 patients (2.7%) receiving current standard of care acheived the primary efficacy outcome in the randomized trial.
The primary safety endpoint of superiority for major bleeding was achieved in 0.6% of patients administered with Eliquis and 1.8% of those received current standard of care in the double-blind, multicenter trial.