The Use of Edoxaban in Patients with Nonvalvular Atrial Fibrillation and Venous Thromboembolism: A Pharmacist's Perspective

Abstract

Until 2010, the vitamin K antagonist warfarin was the only available oral anticoagulant for the prevention of stroke or systemic embolic events (SEE) in patients with nonvalvular atrial fibrillation (NVAF) and the treatment of venous thromboembolism (VTE) in the United States. Despite its proven efficacy, the use of warfarin is limited by numerous disadvantages, including a delayed onset of action and variable efficacy resulting from interactions with genetic and environmental factors. Consequently, optimal anticoagulation with warfarin requires dose adjustments based on frequent monitoring. In contrast to warfarin, direct oral anticoagulants (DOACs) including dabigatran, rivaroxaban, apixaban, and edoxaban have predictable pharmacokinetic profiles, few drug-drug interactions, no known interactions with food, and can be administered at fixed doses without the requirement for routine monitoring. All DOACs have received US Food and Drug Administration (FDA) approval for the prevention of stroke or SEE in patients with NVAF and the treatment of VTE based on phase 3 trials demonstrating that they are at least as efficacious as warfarin. In addition, the incidence of clinically relevant bleeding associated with DOACs is comparable to or lower than with warfarin. In this article, the preclinical and clinical data that led to the FDA approval of once-daily edoxaban in January 2015 are presented. Furthermore, practical considerations for edoxaban use including dosing recommendations, transitions of care, reversal of anticoagulation, precautions, contraindications, and cost-effectiveness are discussed. Edoxaban is an important addition to oral anticoagulation options available for the therapeutic management of patients with NVAF or VTE.