Once-daily LIXIANA® (edoxaban) provided a highly effective prevention of stroke and systemic embolism1

Rapid onset of action (within 1 to 2 hours)1

Proven efficacy compared with a well-managed warfarin arm

  • Patients taking warfarin were in the therapeutic INR range (2.0 to 3.0) for 68.4% of the time1,4

The efficacy of LIXIANA® (edoxaban) was also proven in subpopulations of eligible NVAF patients, including those with factors that increase the risk of bleeding1,2,*

Once-daily LIXIANA® (edoxaban) was proven to be efficacious in reducing the risk of haemorrhagic and ischaemic stroke1

Once-daily LIXIANA® (edoxaban) was associated with a significant reduction in cardiovascular mortality compared with well‐managed warfarin1

  • 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.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)2

  • §

    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.