Bristol-Myers Squibb and Pfizer announced the results of the six month Phase 3 AMPLIFY trial in patients with acute venous thromboembolism (VTE), including symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE). Eliquis (apixaban) is an oral direct Factor Xa inhibitor, a key blood clotting protein, that prevents thrombin generation and blood clot formation.
AMPLIFY, (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY), a randomized, double-blind, multicenter trial, in 5,395 patients with confirmed symptomatic DVT or PE requiring treatment for six months, evaluated Eliquis 10mg twice daily for 7 days followed by 5mg twice daily thereafter as a single-agent compared to the current standard of care, initial parenteral enoxaparin treatment overlapped by warfarin therapy. The primary efficacy outcome was the composite endpoint of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death.
Eliquis as a single-agent achieved the primary efficacy endpoint of non-inferiority compared to the standard of care in the reduction of the composite endpoint of recurrent symptomatic VTE or VTE-related death. The primary efficacy outcome occurred in 59 patients receiving Eliquis (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 non-inferiority).
The trial demonstrated a comparable efficacy and safety profile between patients entering the study with a DVT and/or a PE. In patients enrolled with DVT, the primary efficacy outcome occurred in 38 patients (2.2%) in the Eliquis group and 47 patients (2.7%) in the standard of care group (relative risk, 0.83; 95% CI, 0.54 to 1.26; risk difference [Eliquis minus current standard of care] -0.5%; 95% CI, -1.5 to 0.6). In patients enrolled with PE, the primary efficacy outcome occurred in 21 patients (2.3%) in the Eliquis group and 23 patients (2.6%) in the standard of care group (relative risk 0.90; 95% CI, 0.50 to 1.61; risk difference -0.3%; 95% CI, -1.7 to 1.2).
Eliquis is already approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
For more information call (800) 321-1335 or visit www.bms.com.