The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of LIXIANA (edoxaban) in patients with atrial fibrillation (AF) undergoing cardioversion, pharmaceutical Daiichi Sankyo has announced.
This means the drug has been recommended for a label update for use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion. The update is based on data from the ENSURE-AF trial, the largest prospective randomised clinical trial of anticoagulation for cardioversion of patients with non-valvular atrial fibrillation (NVAF), to date.
Edoxoban is now the only non-vitamin K oral anticoagulant (NOAC) with specific label guidance for early cardioversion within two hours after edoxaban intake in the TEE-guided approach.
Cardioversion is a procedure used to restore normal, regular heart rhythm in AF patients. Due to an associated risk of thrombotic events such as stroke, guidelines recommend anticoagulation before and after the procedure. The delayed onset of action and fluctuations in INR associated with VKA treatments such as warfarin, can result in costly and inconvenient delays to cardioversion in patients.
The primary efficacy endpoint of the ENSURE AF study was a composite of stroke, systemic embolic events, myocardial infarction and cardiovascular mortality, which occurred in five patients in the edoxaban 60/30mg arm versus 11 in the enoxaparin-warfarin arm. The primary safety endpoint was major and clinically relevant non-major bleedings (CRNM), which occurred in 16 patients in the edoxaban arm versus 11 patients in the enoxaparin-warfarin arm. The difference between the treatment arms was statistically non-significant.
The data from the trial supports the use of edoxaban as an effective and well tolerated alternative to the best possible conventional treatment with enoxaparin and warfarin.