New oral anticoagulant edoxaban launches

Prescribers now have an additional option for non-warfarin-based oral anticoagulation, with the launch of edoxaban (Lixiana).

Edoxaban treatment should be continued long-term in patients with nonvalvular atrial fibrillation.
Edoxaban treatment should be continued long-term in patients with nonvalvular atrial fibrillation.

Lixiana is indicated in:

  • Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation with one or more risk factors (such as congestive heart failure, hypertension, age ≥75 years, diabetes, prior stroke or transient ischaemic attack)
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
  • Prevention of recurrent DVT and PE

Like rivaroxaban and apixaban, edoxaban is a direct factor Xa inhibitor and thus acts by inhibiting thrombin production. Unlike warfarin, edoxaban does not require anticoagulation monitoring.

Atrial fibrillation

Further information
View Lixiana drug record
Summary of Product Characteristics
Manufacturer: Daiichi Sankyo

In a randomised, double-blind, double-dummy trial (ENGAGE-AF-TIMI), high- and low-dose edoxaban regimens (60mg and 30mg once daily) were tested for non-inferiority to warfarin in patients with moderate- to high-risk atrial fibrillation (n=21,105). The principal safety endpoint was major bleeding.

During the treatment period, a stroke or systemic embolic event occurred in 232 patients in the warfarin group compared with 182 patients in the high-dose edoxaban group (1.50% vs 1.18%, hazard ratio 0.79, 97.5% CI 0.63–0.99; p<0.001 for non-inferiority) and 253 patients (1.61%) in the low-dose edoxaban group (hazard ratio 1.07, 97.5% CI 0.87–1.31; p=0.005 for non-inferiority). 

The annualised rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban and 1.61% with low-dose edoxaban (p<0.001 for both doses vs warfarin). The annualised rates of death from cardiovascular causes were 3.17% for warfarin versus 2.74% (hazard ratio 0.86, 95% CI 0.77–0.97; p=0.01) and 2.71% (hazard ratio 0.85, 95% CI 0.76–0.96; p=0.008) for high- and low-dose edoxaban respectively.

The investigators concluded that both edoxaban regimens were non-inferior to warfarin with respect to prevention of stroke or systemic embolism. Edoxaban was also associated with significantly lower rates of bleeding and death from cardiovascular causes than warfarin.

Venous thromboembolism

second randomised, double-blind, non-inferiority study (Hokusai-VTE) examined the use of edoxaban and warfarin in patients with DVT or PE.

Treatment with edoxaban or warfarin was continued for at least 3 months in all patients and for a maximum of 12 months, with the duration based on patients’ clinical features and preference. 

Recurrence of venous thromboembolism occurred in 130 of 4118 patients (3.2%) in the edoxaban group and in 146 of 4122 patients (3.5%) in the warfarin group (hazard ratio 0.89, 95% CI 0.70−1.13; p<0.001 for non-inferiority). The difference in risk (edoxaban minus warfarin) was −0.39 percentage points (95% CI −1.16 to 0.39).

Rates of major or clinically relevant non-major bleeding were significantly lower with edoxaban than warfarin (8.5% vs 10.3%; hazard ratio 0.81, 95% CI 0.71–0.94; p=0.004 for superiority).

The finding showed that edoxaban was non-inferior to warfarin therapy and caused significantly less bleeding in a broad spectrum of patients with venous thromboembolism.

Adverse effects

As with all anticoagulants, bleeding is a risk in patients taking edoxaban and should be monitored. Anaemia may also occur, as well as skin reactions and altered liver function tests.

Draft NICE recommendation

NICE has issued a Final Appraisal Determination recommending edoxaban as an option for the treatment and prevention of recurrent DVT and PE in adults.  

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