ONCE-DAILY LIXIANA®, A DIRECT FACTOR Xa INHIBITOR

Proven efficacy

Proven efficacy comparable to well-controlled warfarin in the prevention of stroke/SEE (systemic embolic events) in NVAF patients in ENGAGE AF-TIMI 481

Proven efficacy comparable to well-controlled warfarin in the treatment and prevention of recurrent VTE (venous thromboembolism) events following initial use of heparin for at least 5 days in VTE patients in Hokusai-VTE2

Superior reduction in major bleeding vs. well-controlled warfarin in eligible NVAF patients*1

ENGAGE AF-TIMI 48: 20% relative risk reduction (RRR) and 0.68% absolute risk reduction (ARR) in major bleeding vs. well-controlled warfarin (HR 0.80; 95% CI, 0.71 to 0.91; P<0.001 for superiority)1

Superior reduction in clinically relevant bleeding vs. well-controlled warfarin in VTE patients**2

Hokusai-VTE: 19% RRR and 1.8% ARR in clinically relevant bleeding vs. well-controlled warfarin (HR, 0.81; 95% CI, 0.71 to 0.94; P<0.004 for superiority)2

See additional details about ENGAGE AF‐TIMI 48 or Hokusai-VTE.

Simple and convenient once-daily dosing in NVAF3

  • *

    The primary safety endpoint of ENGAGE AF-TIMI was the incidence of adjudicated major bleeding, defined by the International Society on Thrombosis and Haemostasis (ISTH) as (i) fatal bleeding; and/or (ii) symptomatic bleeding in critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome, and/or (iii) bleeding causing a fall in haemoglobin level of 2.0 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells.3

  • **

    The primary safety endpoint of Hokusai-VTE was a composite of major and clinically relevant nonmajor bleeding, as defined by the International Society on Thrombosis and Haemostasis (ISTH). Major bleeding was defined as overt bleeding associated with a decrease in haemoglobin of 2.0 g/L or more, or requiring a transfusion of 2 or more units of blood, occurring in a critical site or contributing to death. 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 other discomfort such as pain, or impairment of activities daily life.4