Direct factor Xa inhibitor edoxaban: from bench to clinical practice.

Edoxaban is a direct factor Xa inhibitor and has become the fourth direct oral anticoagulant (DOAC) approved for stroke prevention in atrial fibrillation (AF) and for treatment and secondary prevention of venous thromboembolism (VTE). This review provides an overview of the key characteristics of edoxaban and clinical evaluation program leading to regulatory approval. Approval for AF and VTE treatment was based on large phase III randomized controlled trials that showed that edoxaban reduces the risk of bleeding compared with warfarin and provides similar protection against thromboembolism. Edoxaban is the second once-daily DOAC, is tested in a reduced dose for patients with a moderate renal impairment, body weight of ≤60 kg or concomitant use of p-glycoprotein inhibitors and thereby is a valuable addition to the therapeutic arsenal of modern anticoagulation. For AF regulatory approval in the USA is limited to patients with a creatinine clearance of 15-95 ml/min. Another limitation is the need for initial parenteral anticoagulation with heparin in treatment of acute VTE.