Edoxaban: Insights from pivotal studies and sub-analyses

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2 CPD/CME credits, 2 hours
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Sponsorship Statement:

The development of this supplement was commissioned and funded by Daiichi Sankyo UK Ltd, which also checked the manuscript for compliance with the ABPI Code of Practice. Editorial control of content was with The British Journal of Cardiology.

Prescribing information for Lixiana® (edoxaban) and adverse event reporting details can be found here.

Job bag number EDX/20/1177 | Date of preparation: November 2020

Learning objectives

In this learning activity, based on a BJC supplement ‘Edoxaban: insights from pivotal studies and sub-analyses’, we learn about the latest findings of the effects of the anticoagulant, edoxaban, including its clinical efficacy in atrial fibrillation and venous thromboembolism, as well as safety outcomes.

This supplement examined:
– that long-term oral anticoagulation is the mainstay of stroke prevention in at-risk subjects. Vitamin K antagonists (VKA), principally warfarin, have been the most commonly used method of oral anticoagulation, but the more recent availability of non-VKA oral anticoagulants (NOACs) has broadened treatment options for these patients
– how effective anticoagulation improves clinical outcomes and safety for patients with atrial fibrillation and venous thromboembolism, who are at risk of adverse events including premature mortality, stroke, cardiovascular events and heart failure
– the latest clinical data for the NOAC, edoxaban, showing its efficacy and safety in a broad range of patient demographic and disease subgroups

The supplement discussed:
– the clinical evidence-base for edoxaban from the randomised controlled studies ENGAGE-AF TIMI-48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48 trial), ENSURE-AF (Edoxaban versus Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation) and The Edoxaban HOKUSAI-VTE Study
– the clinical outcomes of edoxaban compared to warfarin in atrial fibrillation with reference to the patient with existing cardiovascular or cerebrovascular disease, and how operative procedures, age, body mass index, renal function, malignant disease and race, impact on benefit
– the efficacy and safety of edoxaban compared to warfarin in venous thromboembolism, and the impact of age, comorbidity and polypharmacy on outcomes
– how to manage NOACs in a primary care setting. This discusses their convenient dosing, safety and efficacy in a broad range of patient subgroups, and how to overcome perceived barriers, such as bleeding, which have led to their underdosing and underuse


BJC Learning suggests that two hours of learning on this ‘Learning with reflection’ activity should be equivalent to 2 CPD/CME points


This BJC Learning with reflection activity has a recommended award of two credits for the two hours of learning we estimate you will spend on this activity. You will need to read the following articles that comprise the activity:
1. Edoxaban in patients with atrial fibrillation and co-existing cardiovascular disease
2. Edoxaban in stroke prevention in patients with a prior history of stroke or transient ischaemic attack
3. Edoxaban in the treatment and prophylaxis of venous thromboembolism
4. Role of edoxaban in the primary-care setting: opportunities and challenges

After you have read these, you should reflect on what you have learnt and how it will influence your practice, and record this personal reflection in the box beneath the contributors. This will all be saved in the results section of your BJC Learning profile, which you can access at any time. This record can be printed off for revalidation purposes.


Khalid Khan, Consultant Cardiologist, Betsi Cadwaladr Univeristy Health Board
Honey Thomas, Consultant Cardiologist, Northumbria Healthcare NHS Foundation Trust
Paul Guyler, Consultant Stroke Physician, Southend University Hospital NHS Trust
Jecko Thachil, Consultant Haematologist, Manchester University NHS Foundation Trust
Nigel Rowell, Retired General Practitioner, previously at Endeavour Practice, Middlesbrough


Medical knowledge is constantly changing. As new information becomes available, changes in treatment, procedures, equipment and the use of drugs become necessary. The editors/authors/contributors and the publishers Medinews (Cardiology) Ltd have taken care to ensure that the information given in this text is accurate and up to date at the time of publication.

Readers are strongly advised to confirm that the information, especially with regard to drug usage, complies with the latest legislation and standards of practice. Medinews (Cardiology) Limited advises healthcare professionals to consult up-to-date Prescribing Information and the full Summary of Product Characteristics available from the manufacturers before prescribing any product. Medinews (Cardiology) Limited cannot accept responsibility for any errors in prescribing which may occur.

The opinions, data and statements that appear are those of the contributors. The publishers, editors, and members of the editorial board do not necessarily share the views expressed herein. Although every effort is made to ensure accuracy and avoid mistakes, no liability on the part of the publisher, editors, the editorial board or their agents or employees is accepted for the consequences of any inaccurate or misleading information.

© Medinews (Cardiology) Ltd 2020. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of the publishers, Medinews (Cardiology) Ltd. It shall not, by way of trade or otherwise, be lent, re-sold, hired or otherwise circulated without the publisher’s prior consent.

Use for revalidation – BJC Learning with reflection activity

This article can be used towards revalidation. If you would like to reflect on what you have learned, please log in or register to record your thoughts on how this article has influenced your practice.