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.