EFFICACY AND SAFETY IN NVAF AND VTE

LIXIANA® (edoxaban) is a once-daily, oral, direct factor Xa inhibitor that combines effective prevention of thrombotic events and superiority vs warfarin for the primary safety endpoints (reduction in major§ bleeding in the NVAF pivotal trial, and reduction in the composite of major and clinically relevant nonmajor bleeding in the VTE pivotal trial)1,2

Proven efficacy in ENGAGE AF‐TIMI 48 and Hokusai‐VTE—robust trials that evaluated LIXIANA® (edoxaban) across nonvalvular atrial fibrillation (n=21,105) and venous thromboembolism (VTE) patients (n=8292) with a broad range of disease severities and risk factors—to help you address the needs of your many different nonvalvular atrial fibrillation and VTE patients1,2


Superiority vs well-managed warfarin for the primary safety endpoints (reduction in major§ bleeding in nonvalvular atrial fibrillation and in the composite of major and clinically relevant nonmajor bleeding in venous thromboembolism)1,2

Nonvalvular atrial fibrillation: Superior 20% relative risk reduction (RRR) in major bleeding§ compared with warfarin (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.71 to 0.91; P<0.001 for superiority).1

VTE: Superior 19% relative risk reduction (RRR) in clinically relevant bleeding compared with warfarin (HR, 0.81; 95% CI, 0.71 to 0.94; P=0.004 for superiority.2




See additional details about LIXIANA® (edoxaban) Clinical Trials: ENGAGE AF‐TIMI 48 or Hokusai-VTE.


LIXIANA® (edoxaban) at a glance:

  • *

    One or more of the following factors: moderate renal impairment (creatinine clearance of 30-50 mL/min), low body weight (≤60 kg/132 lbs), concomitant use of P-glycoprotein inhibitors (eg, cyclosporine, dronedarone, ketoconazole, erythromycin).

  • §

    Major bleeding in nonsurgical patients was defined as4

    1. Fatal bleeding, and/or
    2. Symptomatic bleeding in critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or
    3. Bleeding causing a fall in haemoglobin level of 20 g/L-1 (1.24 mml/L-1) or more, or leading to transfusing of 2 or more units of whole blood or red cells.
  • Clinically relevant nonmajor bleeding was defined as overt bleeding not meeting the criteria for major bleeding§ but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or leading with any other discomfort such as pain, or impairment of activities of daily life.2