LIXIANA® CLINICAL TRIALS

Efficacy and tolerability of LIXIANA® was demonstrated by the largest NVAF and VTE trials to date with a NOAC1,2

ENGAGE AF-TIMI 48 was the largest (21,105 patients) and longest (2.8 years median follow-up) comparative NVAF study to date with a NOAC1

Hokusai-VTE
Hokusai-VTE

Hokusai-VTE is the largest (8,292 patients) single comparative VTE trial to date with a NOAC2



Dosing information

The LIXIANA® clinical trials prospectively accounted for patients with one or more factors which put them at increased risk of bleeding and therefore received a 30 mg reduced dose of LIXIANA®:1,2

  • Renal impairment (CrCl 30 to 50 ml/min)
  • Low body weight (≤60 kg/132 lbs)
  • Concomitant use of P-gp inhibitors verapamil, dronedarone or quinidine*

A broad range of NVAF and DVT/PE patient subgroups were evaluated1,2

  • ENGAGE AF-TIMI 48 enrolled a high percentage of NVAF patients who also had comorbidities or other risk factors1
  • Hokusai-VTE Trial studied a broad range of DVT and PE patients with varying severities or other risk factors2


Access the ENGAGE AF-TIMI 48 and Hokusai-VTE publications

  •  *

    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.