08.12.2016 – 13:01
Daiichi Sankyo Announces Initiation of Real-World Study in LIXIANA® (edoxaban) Patients Undergoing Diagnostic and Therapeutic Procedures in NVAF and VTE
First patient enrolled in EMIT-AF/VTE study (NCT02950168), a European registry to assess edoxaban management in patients undergoing medical procedures
Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today announced that the first patient has been enrolled in the EMIT-AF/VTE (Edoxaban Management In diagnostic and Therapeutic procedures) study. This registry will collect real-world clinical data on the use of once-daily LIXIANA® (edoxaban) with regard to diagnostic and interventional procedures in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE).
Limited information is currently available regarding the use of edoxaban in patients undergoing medical procedures. Patients who are treated with non-vitamin K antagonist oral anticoagulants (NOACs), such as edoxaban, undergo diagnostic and therapeutic procedures at a rate of 10% a year, and if the surgical interventions carry a bleeding risk, NOAC treatment must be temporarily discontinued. The EMIT-AF/VTE study will provide further insight into the use of edoxaban in patients undergoing diagnostic and therapeutic procedures.
Patients will be enrolled from primary and secondary care settings, as well as other specialty settings. The primary objective of the study is to document the peri-procedural management of edoxaban and collect data on safety and other outcomes in these patients. The primary safety outcome is the rate of major bleeding (within 30 days post intervention) using the ISTH definition.
"The EMIT-AF/VTE registry is part of the extensive clinical research programme undertaken for edoxaban," said Dr. Juan-Carlos Jaramillo, Head of Market Access and Medical Affairs at Daiichi Sankyo Europe GmbH. "This registry will provide important information that expands our knowledge on the use of edoxaban and will ensure healthcare professionals are equipped to achieve the best possible outcomes for NVAF and VTE patients undergoing medical procedures."
The EMIT-AF/VTE registry will comprise approximately 2,000 patients over the next two and a half years. Data will be collected from patients treated with edoxaban for 2,000 planned or unplanned procedures across 500 sites, including hospitals and office-based sites, in Belgium, France, Germany, Italy, The Netherlands, Spain, and the UK. Daiichi Sankyo is also reviewing options to expand the EMIT-AF/VTE registry to clinical sites beyond Europe.
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EMIT-AF/VTE is a real-world, multinational, multicentre, prospective observational, non-interventional study. The registry will include data from NVAF and VTE patients until 2,000 procedures have been documented over a period of around two and a half years. The study is being conducted across seven European countries, and Daiichi Sankyo is evaluating the inclusion of additional countries, beyond Europe. The primary objective of EMIT-AF/VTE is to collect data on the usage pattern of edoxaban in the context of diagnostic or interventional procedures in unselected patients with NVAF or VTE. The primary safety outcome is the rate of major bleeding within 30 days post-procedure. Secondary objectives include assessing efficacy outcomes as a composite of major cardiovascular events and collecting details on the types of diagnostic or therapeutic procedures.
Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components in the coagulation cascade responsible for blood clotting. Inhibition of factor Xa reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation.
Edoxaban is currently marketed in Japan, the U.S., Switzerland, the U.K., Germany, Ireland, the Netherlands, South Korea, Taiwan, Italy, Spain, Hong Kong, Belgium and other European countries.
Edoxaban is approved in Europe for the prevention of stroke and systemic embolic events in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age >= 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) and for the treatment of DVT and PE and prevention of recurrent DVT and PE in adults.
The edoxaban Summary of Product Characteristics can be viewed here:
About Edoxaban Clinical Research Programme (ECRP)
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our 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). The edoxaban clinical research programme includes multiple RCTs (randomised, 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 programme, 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.
Daiichi Sankyo Fights Thrombosis
Daiichi Sankyo is your partner in antithrombotic therapy with the discovery and development of innovative products, to help patients with a wide range of cardiovascular conditions. These include EFIENT® (prasugrel) for acute coronary syndromes and LIXIANA® (edoxaban) for non-valvular atrial fibrillation, deep vein thrombosis and pulmonary embolism. Daiichi Sankyo's ongoing commitment in this field is demonstrated by their continued investment into patient-relevant clinical development activities that aim to advance the care and improve the lives of people suffering with these diseases. For more information, please visit: www.daiichi-sankyo.eu.
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: http://www.daiichisankyo.com.
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. Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT-AF/VTE), ClinicalTrials.gov, https://clinicaltrials.gov/ct2/ show/NCT02950168?term=edoxaban&rank=1. [Last accessed December 2016]. 2. LIXIANA. Summary of Product Characteristics (SmPC), 2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_library /EPAR_-_Product_Information/human/002629/WC500189045.pdf . [Last accessed December 2016].
Lydia Worms (Europe) Daiichi Sankyo Europe GmbH Edoxaban Communications & Product PR Europe +49-(89)-7808751
Original content of: Daiichi Sankyo Europe GmbH, transmitted by news aktuell