Eliquis® (apixaban) Demonstrated Comparable Efficacy And Significantly Lower Rates Of Major Bleeding In Patients Compared To Current Standard Of Care For The Treatment Of Acute Venous Thromboembolism
Based on the results of AMPLIFY, as well as AMPLIFY-EXT, which were published online on December 8, 2012, in New England Journal of Medicine with simultaneous presentation during a late-breaker session at the 54th Annual Meeting of the American Society of Hematology (ASH), Bristol-Myers Squibb and Pfizer plan to initiate regulatory filings for the initial and long-term treatment of VTE, as well as for extended prevention of recurrent VTE.
AMPLIFY, ( Apixaban for the initial Management of Pu Lmonary embol Ism and deep vein thrombosis as First-line therap Y), a randomized, double-blind, multicenter trial, included 5,395 patients with confirmed symptomatic DVT or PE requiring treatment for six months, and evaluated Eliquis as a single-agent (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) compared to current standard of care (initial parenteral enoxaparin treatment overlapped by warfarin therapy). Approximately one third of patients in the trial had a PE at the time of enrollment into the study.
The primary efficacy outcome was the composite endpoint of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death. For the primary efficacy outcome, Eliquis achieved noninferiority to parenteral enoxaparin plus warfarin in the reduction of recurrent symptomatic VTE or VTE-related death. The primary efficacy outcome occurred in 59 patients in the Eliquis group (2.3%) and 71 patients (2.7%) receiving current standard of care (relative risk 0.84%; 95% CI, 0.60 to 1.18; P<0.0001 for noninferiority).Eliquis achieved the primary safety endpoint of superiority for major bleeding. Major bleeding occurred in 0.6% of patients given Eliquis and 1.8% of those given current standard of care (relative risk, 0.31; 95% CI, 0.17 to 0.55; P<0.0001 for superiority). The composite of major and clinically relevant nonmajor bleeding occurred in 4.3% and 9.7% of patients in the Eliquis and current standard of care groups, respectively (relative risk, 0.44; 95% CI, 0.36 to 0.55). Rates of other adverse events were similar in the two groups.
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