COMUNICADO: Daiichi Sankyo Announces Initiation of Real-World Study in LIXIANA®▼ (edoxaban) Patients Undergoing Diagnostic and Thera

Publicado 08/12/2016 13:01:25CET

MUNICH, December 8, 2016 /PRNewswire/ --

First patient enrolled in EMIT-AF/VTE study (NCT02950168), a European registry to

assess edoxaban management in patients undergoing medical procedures[1]

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(R) (edoxaban) with regard to diagnostic and interventional procedures in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE).[1]  

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.[1]

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.[1]

"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[1] 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.[1]

About Edoxaban 

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 greater than or equal to 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.[2]

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
- 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
- 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  


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