November 7, 2016Expert Opinion on Drug Metabolism & Toxicology

Clinical relevance of pharmacokinetic and pharmacodynamic properties of edoxaban when treating patients with atrial fibrillation and heart failure

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Why the study?

Does edoxaban safely and effectively prevent stroke and systemic embolism in patients with atrial fibrillation and coexisting heart failure?

Structured PICO

Does edoxaban safely and effectively prevent stroke and systemic embolism in patients with atrial fibrillation and coexisting heart failure?

Population

Patients with atrial fibrillation, particularly those with coexisting heart failure and special populations including patients aged ≥75 years, with renal impairment, poor adherence, and on polypharmacy

Intervention

Edoxaban

Comparator

Warfarin (as referenced in the pivotal ENGAGE AF-TIMI 48 trial)

Outcome

Prevention of stroke and systemic embolism

Edoxaban has a favorable pharmacological profile that supports its use for stroke prevention in complex atrial fibrillation patients, including those with concurrent heart failure or renal impairment.

Implication

NOACs provide convenient stroke prevention in elderly AF patients with HF; reinforces pivotal trial data for first-line use in this high-risk group.

Abstract

INTRODUCTION: Atrial fibrillation (AF) is an independent risk factor for stroke. It is most prevalent in the elderly and frequently coexists with heart failure (HF). The joint occurrence of AF and HF further worsens prognosis. The prevention of thromboembolism is crucial in the management of AF. In recent years, new oral anticoagulants (NOACs) have been licensed for the prevention of stroke and systemic embolism in patients with AF. Areas covered: This article reviews the key published studies on the pharmacology, clinical efficacy and safety of edoxaban, the latest NOAC to receive approval for the AF indication. This potent and selective inhibitor of factor Xa shows predictable pharmacokinetic and pharmacodynamic profiles. Its efficacy and safety have been demonstrated in the pivotal, phase III, warfarin-controlled ENGAGE AF-TIMI 48 trial in 21,105 AF patients. Expert opinion: NOACs will likely improve the management of AF, with or without HF. Edoxaban has a favorable pharmacokinetic profile that supports its use in special patient populations, including patients aged ≥75 years, with HF, renal impairment, poor adherence, and on polypharmacy. Proven strategies of edoxaban dose-reduction for optimal use in the presence of moderate renal impairment, and/or use of strong P-gp inhibitors are available.