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Daiichi Sankyo Europe GmbH

About the Danish Registry

The Danish registry is an observational cohort study based on data from the Danish nationwide administrative registries.1 It is one of the largest observational studies in mainly Caucasian AF patients. Data from a total of 2,285 eligible Danish AF patients, who were taking edoxaban from 1 July 2016 to 1 November 2018, were included in the study.1

The primary efficacy outcome was thromboembolism, comprised by a composite outcome of ischemic stroke and systemic embolism.1 The safety outcomes were a composite of all bleedings, including intracranial and gastrointestinal bleeding, and major bleeding in other anatomic sites.1 The safety outcome was also investigated in conjunction with hospitalisation.1 All-cause mortality was investigated as an independent endpoint, and stratified according to patient’s status on cancer diagnosis within three years before initiation of edoxaban treatment, realising that cancer (whether active or cured) is associated with mortality.1

About Atrial Fibrillation
AF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.3
 
AF is the most common type of heart rhythm disorder and is associated with substantial morbidity and mortality.4 More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.5,6  Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.7 One in five of all strokes are as a result of AF.4
 
About Edoxaban
Edoxaban is an oral, once-daily, direct factor Xa (pronounced “Ten A”) inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Edoxaban is currently marketed by Daiichi Sankyo and its partners in more than 30 countries and regions around the world.

References

1. Nielsen PB, et al. Effectiveness and safety of edoxaban in patients with atrial fibrillation: data from the Danish nationwide cohort. Eur Heart J Cardiovasc Pharmacother. 2019. doi: 10.1093/ehjcvp/pvz070 [Epub ahead of print].
2. Giugliano RP, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013. 369(22):2093-104.
3. National Heart, Lung and Blood Institute – What is Atrial Fibrillation. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html. [Last accessed: December 2019].
4. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485):238–43.
5. Camm A, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31(19):2369-2429.
6. Krijthe BP, et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013;34(35):2746-2751.
7. Ball J, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card. 2013;167:1807-1824.