PROVEN REDUCTION OF VTE RISK1

Once-daily LIXIANA® (edoxaban) effectively prevented symptomatic recurrent VTE (including DVT and fatal and nonfatal PE) across a broad range of eligible patients.1

Symptomatic recurrent VTE included deep vein thrombosis (DVT) and fatal and nonfatal pulmonary embolism (PE).


Proven efficacy compared with a well-managed warfarin arm

  • Eligible patients taking warfarin were in the therapeutic INR range (2.0 to 3.0) for 63.5% of the time


In major subpopulations of eligible VTE patients, bleeding results were consistent with the overall study population.1,2

Once-daily LIXIANA® (edoxaban) was proven effective across a broad range of eligible VTE patients—including those with more severe disease (such as eligible patients with extensive DVT or PE associated with right ventricular dysfunction)1

Once-daily LIXIANA® (edoxaban) was also proven to effectively prevent symptomatic recurrent VTE in a subgroup analysis of patients with PE associated with right ventricular dysfunction (RVD)1

  • A phase 3, multinational, double-blind, double-dummy, event-driven, noninferiority trial designed to evaluate the efficacy and safety of once-daily LIXIANA® (edoxaban) 60 mg vs dose-adjusted warfarin (target INR of 2.0-3.0) in patients with VTE (n=8292) after initial treatment with heparin. LIXIANA® (edoxaban) dosage was reduced by half if any of the following was present at randomisation or during the course of the study: creatinine clearance 30-50 mL/min, body weight ≤60 kg, or use of concomitant potent P-gp inhibitors. Patients received the study drug for 3 to 12 months. The primary efficacy outcome was recurrent symptomatic VTE. The principal safety outcome was clinically relevant bleeding (defined as major* or clinically relevant nonmajor bleeding§). Warfarin therapy was proactively monitored throughout the trial, resulting in a median TTR of 63.5%. Patients 18 years of age or older were eligible if they had objectively diagnosed, acute, symptomatic DVT involving the popliteal, femoral, or iliac veins or acute symptomatic PE (with or without DVT).1

  • *

    Major bleeding in nonsurgical patients was defined as5

    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 associated with any other discomfort such as pain, or impairment of activities of daily life.1

  • 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).4