Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation

2.1 Edoxaban (Lixiana, Daiichi Sankyo) is an anticoagulant that directly inhibits factor X (factor Xa), which is a key component in the formation of blood clots. It is administered orally. Edoxaban has a marketing authorisation for the 'prevention of stroke and systemic embolism in adult patients with non‑valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).' The summary of product characteristics states that the recommended dose is 60 mg once daily. The recommended dose is 30 mg once daily in people with one or more of the following clinical factors: moderate or severe renal impairment (creatinine clearance 15 to 50 ml/min); body weight of 60 kg or less; concomitant use of the P‑glycoprotein inhibitors ciclosporin, dronedarone, erythromycin or ketoconazole.

2.2 The summary of product characteristics includes the following adverse reactions for edoxaban: bleeding, anaemia, nausea, rash, hepatobiliary disorders (increased blood bilirubin and gamma‑glutamyl transferase) and abnormal liver function test. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 Edoxaban costs £58.80 for a 28‑tablet pack (60 mg or 30 mg) and the daily cost of treatment is £2.10 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.