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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

AMPLIFY 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 apixaban group and 47 patients (2.7%) in the current standard of care group (relative risk, 0.83; 95% CI, 0.54 to 1.26; risk difference [apixaban 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 apixaban group and 23 patients (2.6%) in the current 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).

About Eliquis ®

Eliquis ® (apixaban) is an oral direct Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis prevents thrombin generation and blood clot formation. Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the United States, European Union (which includes 27 member states plus Iceland and Norway), Japan and a number of other countries around the world. Eliquis is approved for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery in the European Union (which includes 27 member states plus Iceland and Norway) and a number of other countries around the world. Eliquis is not approved for this indication in the U.S.

IMPORTANT SAFETY INFORMATION FOR ELIQUIS

BOXED WARNING: DISCONTINUING ELIQUIS IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE.

Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered .

CONTRAINDICATIONS

- Active pathological bleeding

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