AF is the most common type of heart rhythm disorder and is associated with substantial morbidity and mortality.([6]) More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.([7],[8]) Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.([9]) One in five of all strokes are a result of AF.([7])
About the Edoxaban Clinical Research Programme
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 the Edoxaban Clinical Research Programme, 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 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.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com [http://www.daiichisankyo.com/].
Forward-looking statements
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
Contact: Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Comm. & Product PR Europe
+49-(89)-7808751
References
1. Goette A, et al. Edoxaban-based versus vitamin-K-antagonist-based anti-thrombotic regimen following successful coronary stenting in atrial fibrillation patients. The ENTRUST-AF PCI trial. Presented at ESC Congress 2019; September 03, 2019; Paris.
2. Vranckx P, et al. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. The Lancet, 2019. Available at: http://dx.doi.org/10.1016/S0140-6736(19)31872-0 [http://dx.doi.org/10.1016/S0140-6736(19)31872-0]. [Last accessed September 2019].
3. Capodanno D, et al. Management of antithrombotic therapy in atrial fibrillation patients undergoing PCI: JACC State-of-the-Art Review. J Am Coll Cardiol 2019; 74(1): 83-99.
4. Steffel J, et al. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J, 2018;39(16):1330-1393.
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