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For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: George Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Executive Officer,
Vice President, Corporate Communications Department
Daiichi Sankyo Initiates ENTRUST-AF PCI Study Investigating Once-Daily Lixiana® (edoxaban) in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention with Stenting
・ENTRUST-AF PCI is the first study to evaluate edoxaban in atrial fibrillation patients following a successful percutaneous coronary intervention
・Study adds to the growing Edoxaban Clinical Research Program (ECRP) evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings
Tokyo, Japan, (March 7, 2017) – Daiichi Sankyo Company, Limited (hereafter, “Daiichi Sankyo”) today announced that the first patient has been enrolled into the ENTRUST-AF PCI study. The multinational, randomized phase 3b study will evaluate a treatment regimen based on the company’s oral, once-daily direct factor Xa-inhibitor edoxaban (known by the brand name LIXIANA® outside the US and SAVAYSA® in the US) against a vitamin K antagonist based regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement to investigate the incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB).1 1,500 patients will be enrolled in ENTRUST-AF PCI from 200 clinical sites across Europe, Korea, Taiwan and the Ukraine.1
“The optimal antithrombotic strategy for atrial fibrillation patients undergoing PCI with coronary stent implantation is unknown at this time,” said Pascal Vranckx, MD, Clinical Consultant in Interventional Cardiology and Medical Director of Cardiac Critical Care Services at the Hartcentrum Hasselt, Belgium. “The ENTRUST-AF PCI study will evaluate the role of edoxaban as part of a dual antithrombotic treatment strategy compared to a vitamin-K antagonist based antithrombotic strategy as recommended by current guidelines.”
“ENTRUST AF-PCI is an important study for atrial fibrillation patients undergoing PCI who require antiplatelet therapy and chronic edoxabanfor stroke prevention”, said Andreas Goette, MD, Chief Physician, St. Vincenz-Hospital Paderborn, Germany, Department of Cardiology and Intensive Care Medicine and principal study investigator. “In this study, edoxaban will be used with the approved dosage regimenfor stroke prevention in atrial fibrillation.”
“ENTRUST-AF PCI will add to the growing body of evidence in the Edoxaban Clinical Research Program, and the results will advance clinicians’ understanding of the potential to reduce the risk of bleeding in atrial fibrillation patients undergoing PCI procedures,” said Hans Lanz, MD, Executive Director, Global Medical Affairs, Daiichi Sankyo.
About ENTRUST-AF PCI
EdoxabaN TReatment VersUS Vitamin K Antagonist in PaTients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ENTRUST-AF PCI) is a prospective, randomized, open-label, blinded endpoint evaluation parallel-group phase 3b study to evaluate the efficacy and safety of once-daily edoxaban against a regimen of a vitamin K antagonist in atrial fibrillation patients following successful percutaneous coronary intervention (PCI) with stent placement in terms of the incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB). 1,500 patients will be enrolled in ENTRUST-AF PCI from 200 clinical sites across Europe, Korea, Taiwan and the Ukraine. Patients will be randomized to receive a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist or a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12 antagonist and 1-12 months ASA.1,2
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02866175?term=ENTRUST-AF+PCI&rank=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.5
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 in Japan, the U.S., South Korea, Hong Kong, Taiwan, Switzerland, the U.K., Germany, Ireland, the Netherlands, Italy, Spain, Belgium, Austria, Portugal, and other European countries.
About Edoxaban Clinical Research Program (ECRP)
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The edoxaban clinical research program includes multiple RCTs (randomized, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research program, including completed, ongoing and future research.
The RCTs include:
− 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)
In addition, global and regional registry studies will provide important real-world data about the use of edoxaban and other oral anticoagulants in everyday practice, and include:
− ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with non valvular 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
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 Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 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 and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com.
Lydia Worms (Europe)
Daiichi Sankyo Europe GmbH
Edoxaban Communications & Product PR Europe
+49 (89) 7808751
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.
1. Vranckx, P, et al. Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ENTRUST-AF PCI). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-2017. Available from https://clinicaltrials.gov/ct2/show/NCT02866175?term=ENTRUST-AF+PCI&rank=1 NLM Identifier: NCT02866175.
2. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37(38):2893-2962.
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: February 2017].
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.