PROVEN RESULTS ACROSS SUBGROUPS1,2

The efficacy of once-daily LIXIANA® (edoxaban) was proven across most major subpopulations of eligible NVAF patients1,2,§

Proven efficacy in eligible patients with factors that increase the risk of bleeding who were dose-reduced to LIXIANA® (edoxaban) 30 mg2,5

The safety of once-daily LIXIANA® (edoxaban) was established across major subpopulations of eligible NVAF patients1,2

Significant reduction in major bleeding events compared with warfarin in eligible patients with factors that increase bleeding risk who were dose reduced to LIXIANA® (edoxaban) 30 mg2

LIXIANA® (edoxaban) is proven to reduce rates of key bleeding types and to provide similar net clinical benefit in elderly patients vs warfarin1

LIXIANA® (edoxaban) is proven to reduce rates of major bleeding* vs well-managed warfarin in patients with renal impairment1

LIXIANA® (edoxaban) is proven to significantly reduce major bleeding* vs warfarin in high-risk patients

  • A phase 3, multinational, double-blind, double-dummy, noninferiority trial comparing once-daily LIXIANA® (edoxaban) with warfarin in 21,105 patients with nonvalvular atrial fibrillation at moderate to high risk of stroke (CHADS2 ≥2). Patients were randomised to receive warfarin (n=7036), LIXIANA® (edoxaban) 60 mg (n=7035) or LIXIANA® (edoxaban) 30 mg (n=7034) for up to 2.8 years (median follow-up duration). LIXIANA® (edoxaban) dosage was reduced by half if one or more of the following were present at randomisation or during the course of the study: creatinine clearance 30-50 mL/min, body weight ≤60 kg, or concomitant verapamil, quinidine, or dronedarone. The primary efficacy endpoint was reduction in stroke or systemic embolic events, and the primary safety endpoint was reduction in major bleeding* events. Warfarin therapy (target INR of 2.0-3.0) was proactively monitored throughout the trial, resulting in a median time within therapeutic range (TTR) of 68.4%. Adverse events (excluding bleeding) and discontinuation rates were similar among the 3 treatment groups.

  • *

    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.
  • §

    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