![]() ![]() prior stroke/transient ischemic attack, age, risk of falls, renal function, hepatic disease, ischemic heart disease, heart failure, valvular heart disease, cancer). The relative efficacy (stroke/systemic embolism) and safety (major bleeding) of edoxaban 60 mg compared with warfarin were independent of different clinical conditions (i.e. The ENGAGE AF–TIMI 48 trial showed that edoxaban 60 mg was noninferior to warfarin for the prevention of stroke or systemic embolism, but significantly reduced the risk of bleeding, major adverse cardiac events and death from cardiovascular causes. ![]() Edoxaban seems a cost-effective alternative to warfarin among AF patients with moderate to high thromboembolic risk.Įdoxaban is a once-daily oral inhibitor of factor Xa, currently indicated for the prevention of stroke or systemic embolism in patients with nonvalvular AF. Data about the effectiveness and safety of edoxaban in real-life patients are scarce, but consistent with those of the pivotal clinical trial. The relative efficacy and safety of edoxaban 60 mg compared with warfarin were independent of different clinical conditions, such as prior stroke, age, risk of falls, renal function, hepatic disease, ischemic heart disease, heart failure, valvular heart disease, or cancer. The aim of this review was to update the current evidence about the use of edoxaban in AF patients.Įxpert opinion: In the ENGAGE AF–TIMI 48 trial, edoxaban 60 mg was noninferior to warfarin for the prevention of stroke or systemic embolism, but significantly reduced the risk of bleeding, major adverse cardiac events and death from cardiovascular causes. After the publication of this study, a great number of substudies and post hoc analyses have been published, together with some observational studies. All rights reserved.Introduction: Edoxaban is the last direct oral anticoagulant marketed for the prevention of stroke among patients with nonvalvular atrial fibrillation (AF).Īreas covered: ENGAGE AF–TIMI 48 was the pivotal clinical trial that led to the approval of edoxaban 60 mg once daily. The expected median follow-up is 24 months.ĮNGAGE AF-TIMI 48 is a phase 3 comparison of the novel oral factor Xa inhibitor edoxaban to warfarin for the prevention of thromboembolism in patients with atrial fibrillation.Ĭopyright © 2010 Mosby, Inc. The primary safety end point is modified International Society on Thrombosis and Haemostasis major bleeding. The primary objective is to determine whether edoxaban is noninferior to warfarin for the prevention of stroke and systemic embolism. ![]() Randomization is stratified by CHADS(2) score and anticipated drug exposure. Eligibility criteria include electrical documentation of atrial fibrillation ≤12 months and a CHADS(2) score ≥2. ![]() Blinded treatment is maintained through the use of sham international normalized ratios in patients receiving edoxaban. The edoxaban strategies provide for dynamic dose reductions in subjects with anticipated increased drug exposure. Approximately 20,500 subjects will be randomized to edoxaban high exposure (60 mg daily, adjusted for drug clearance), edoxaban low exposure (30 mg daily, adjusted for drug clearance), or warfarin titrated to an international normalized ratio of 2.0 to 3.0. Edoxaban is a selective and direct factor Xa inhibitor that may provide effective, safe, and more convenient anticoagulation.ĮNGAGE AF-TIMI 48 is a phase 3, randomized, double-blind, double-dummy, multinational, noninferiority design megatrial comparing 2 exposure strategies of edoxaban to warfarin. Their limitations include multiple food and drug interactions and need for frequent monitoring and dose adjustments. Vitamin K antagonists have been the standard oral antithrombotic used for more than a half century for prevention and treatment of thromboembolism. ![]()
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