CONSISTENT RESULTS ACROSS SUBGROUPS1,2

In major subpopulations of eligible patients taking once-daily LIXIANA® (edoxaban), efficacy results were consistent with the overall study population2,*

Proven efficacy in eligible patients with factors that increase the risk of bleeding who were dose-reduced to LIXIANA® (edoxaban) 30 mg1

In major subpopulations of eligible patients taking once-daily LIXIANA® (edoxaban), safety results were consistent with the overall study population1,2

Significant reduction in major bleeding compared with warfarin in eligible patients with factors that increase the risk of bleeding who were dose-reduced to LIXIANA® (edoxaban) 30 mg1

  • 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).

  • *

    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

  • §

    Major bleeding in nonsurgical patients was defined as3

    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