Edoxaban Info

About ETNA-AF 

ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) is a global programme that combines data from distinct non-interventional studies in Europe, East Asia, and Japan in a single database. A total of more than 28,000 patients will be included in the ETNA-AF registries and followed for two years (patients in Europe will be followed for four years). The primary objective of ETNA-AF is to collect information on the use of edoxaban in routine clinical practice, including the safety and efficacy profile in non-preselected patients with NVAF.^1,2,3,4,5

About ENVISAGE-TAVI AF

EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation – Atrial Fibrillation (ENVISAGE-TAVI AF) was a prospective, randomised, open-label, blinded endpoint evaluation, parallel-group phase 3b study, evaluating the efficacy and safety of once-daily edoxaban against a regimen of a vitamin K antagonist, with or without antiplatelet therapy, in AF patients following successful TAVI.^6,7,8 The primary efficacy endpoint was incidence of NACE, i.e., the composite of all-cause death, MI, ischaemic stroke, systemic embolic event (SEE), valve thrombosis, and major bleeding (ISTH definition).^6,7,8 The primary safety endpoint was major bleeding (ISTH definition).^6,7,8 At the completion of the trial, 1,426 patients were enrolled in ENVISAGE-TAVI AF from 173 clinical sites across Europe, North America and Asia. Edoxaban was used with the approved dosage regimen for stroke prevention in AF in each country.^6,7

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02943785

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.⁹

AF is the most common type of heart rhythm disorder and is associated with substantial morbidity and mortality.¹⁰ More than six million Europeans are diagnosed with AF, and this figure is expected to at least double by 2060.^11,12 Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.¹³ One in five of all strokes are as a result of AF.¹¹

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 40 countries and regions around the world.

About the Edoxaban Clinical Research Programme, EDOSURE

More than 10 studies, more than 100,000 patients worldwide

Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through research programmes evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE) designed to further build on the results of the pivotal ENGAGE-AF and Hokusai-VTE studies. More than 100,000 patients worldwide are expected to participate in EDOSURE, which is comprised of more than 10 RCTs (randomised, controlled trials), registries and non-randomised clinical studies, including completed, ongoing and future research. Our goal is to generate new edoxaban clinical and real-world-data regarding its use in AF and VTE populations, providing physicians and patients worldwide with greater treatment assurance.

The RCTs include:

• ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation), in AF patients at moderate-to-high risk of thromboembolic events
• Hokusai VTE (Edoxaban in Venous Thromboembolism), in patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both
• ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation), in AF patients undergoing electrical cardioversion
• ENTRUST-AF PCI (EdoxabaN TReatment versUS VKA in paTients with AF undergoing PCI), in AF patients undergoing percutaneous coronary intervention
• Hokusai-VTE Cancer (Edoxaban in Venous Thromboembolism Associated with Cancer), in patients with cancer and an acute VTE event
• ELDERCARE-AF (Edoxaban Low-Dose for EldeR CARE AF patients), in elderly AF patients in Japan
• ELIMINATE-AF (EvaLuatIon of edoxaban coMpared with VKA IN subjects undergoing cAThEter ablation of non-valvular Atrial Fibrillation)
• ENVISAGE-TAVI AF (EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation (TAVI) – Atrial Fibrillation)
• STABLED Study (STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation) in Japan
• ENRICH-AF (EdoxabaN foR IntraCranial Hemorrhage survivors with Atrial Fibrillation, an investigator initiated phase III study)

In addition, global and regional registry and non-randomised clinical studies provide important real-world and clinical data about the use of edoxaban and other oral anticoagulants in everyday practice; these include:

• ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation)
• ETNA-VTE (Edoxaban Treatment in routiNe clinical prActice in patients with Venous ThromboEmbolism)
• EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures-AF/VTE)
• Prolongation PREFER in AF (PREvention oF thromboembolic events – European Registry) in patients with AF
• ANAFIE (All Nippon AF In Elderly) Registry in Japan
• Cancer-VTE Registry in Japan
• RYOUMA (Real world ablation therapY with anti-cOagUlants in Management of Atrial fibrillation) Registry in Japan
• KYU-RABLE (Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation) in Japan
• BPV-AF (Atrial Fibrillation with BioProsthetic valve) Registry in Japan

Through the edoxaban clinical research programme, we are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realise our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”

For more information, please visit www.daiichi-sankyo.eu.  

Forward-looking statements

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