EFFICACY AND SAFETY OF ONCE-DAILY LIXIANA® IN THE TREATMENT AND PREVENTION OF RECURRENT VTE

Choose once-daily LIXIANA® for:

Proven efficacy in Hokusai-VTE
LIXIANA® demonstrated proven efficacy comparable to well-controlled warfarin in the treatment and prevention of recurrent VTE (DVT and PE) following initial heparin use for at least 5 days – in the largest VTE trial to date with a NOAC1
Superior reduction in clinically relevant bleeding
Superior reduction in clinically relevant bleeding vs. well-controlled warfarin1
Simple and convenient once-daily dosing2
Once-daily dosing, with or without food – after at least five days of initial heparin use in VTE2
  • A Phase 3, randomised, double-blind, double-dummy, event-driven trial that evaluated the efficacy and safety of once-daily LIXIANA® 60 mg compared with well-controlled warfarin (target INR 2.0–3.0) for noninferiority across a broad range of patients with VTE (n=8,292) after initial treatment with heparin.

  • 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.

  • 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 (composite of major and clinically 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.3

  • Clinically relevant non major 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

  • Warfarin therapy was proactively monitored throughout the trial, resulting in a median TTR of 65.6%.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).1

References