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Bristol-Myers Squibb Co And Pfizer Inc Announce Results Of Six Month Phase 3 AMPLIFY Trial Of 5,395 Patients With Acute Venous Thromboembolism


Sunday, 30 Jun 2013 03:48pm EDT 

Bristol-Myers Squibb Co and Pfizer Inc 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% 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 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. 

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