Proven efficacy in Hokusai-VTE

Hokusai-VTE was the largest (8,292) single comparative VTE trial to date with a NOAC. The primary efficacy endpoint was the incidence of adjudicated symptomatic, recurrent VTE (DVT and PE).1

Proven efficacy in the treatment and prevention of recurrent venous thromboembolism (VTE) – comparable to well-controlled warfarin1

  • Patients on the 30 mg reduced dose achieved efficacy consistent with overall trial results.1
  • 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 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 (modified intention-to-treat data).

  • The principal safety outcome was major or 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.4

  • 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.5

  • Warfarin therapy was proactively monitored throughout the trial, resulting in a median TTR of 65.6%.3

  • 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

  • Note: The SPC differs from the clinical trial. Hence, no dose adjustment is required for concomitant use of verapamil, amiodarone and quinidine. In patients taking LIXIANA® and the following P-gp inhibitors; dronedarone, erythromycin, ketoconazole or ciclosporin, the recommended dose is LIXIANA® 30 mg once daily.

  • *

    The overall study period included the period of randomisation through to the end of 12 months or study closure. The on-treatment period included the time during which patients were receiving the study drug or within 3 days after the study drug was stopped or interrupted.