EFFICACY AND SAFETY OF ONCE-DAILY LIXIANA® FOR PREVENTION OF STROKE/SEE IN NVAF PATIENTS

Choose once-daily LIXIANA® for:

Proven efficacy in ENGAGE AF-TIMI 48
LIXIANA® offered proven efficacy comparable to well-controlled warfarin in the prevention of stroke/SEE (systemic embolic events) – demonstrated in a wide range of patients in the largest and longest NVAF trial to date with a NOAC1
Superior reduction in major bleeding
Superior reduction in major bleeding vs. well-controlled warfarin1
Simple and convenient once-daily dosing2
Once-daily dosing, with or without food – in NVAF patients
  • A Phase 3, three-arm randomised, double-blind, double-dummy, event-driven trial comparing two once-daily regimens of LIXIANA® with warfarin in 21,105 patients with moderate to high risk of atrial fibrillation and stroke (CHADS2 score ≥2).

  • Patients were randomised to receive warfarin (n=7,036), LIXIANA® 60 mg (n=7,035) or LIXIANA® 30 mg (n=7,034) for up to 2.8 years (median follow-up duration). LIXIANA® dosage was reduced by 50% if patients had one or more of the following clinical factors: moderate renal impairment (CrCl 30–50 ml/min, low body weight (≤60 kg/132 lbs), or concomitant use of P-glycoprotein (p-gp) inhibitors.

  • The primary efficacy endpoint was time to first stroke (ischaemic or haemorrhagic) or systemic embolism, and the primary safety endpoint was major bleeding as 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

  • 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%.