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24.08.2016 – 09:01

Daiichi Sankyo Europe GmbH

Data from Phase 3b ENSURE-AF Study Investigating Once-Daily LIXIANA® (edoxaban)in Patients with Atrial Fibrillation Undergoing Cardioversion Among 13 Daiichi Sankyo Clinical Presentations at ESC Congress 2016

Munich (ots/PRNewswire)

- ENSURE-AF results to be featured during a late-breaking clinical 
  trial session  
- Five  abstracts highlighting analyses from the global phase 3 
  ENGAGE AF-TIMI 48 study to be presented 
- Seven abstracts to reveal new findings from the PREFER in AF and 
  VTE European patient registries  

Daiichi Sankyo Europe GmbH Group (hereafter, Daiichi Sankyo) today announced the presentation of 13 abstracts at the ESC Congress 2016, taking place from August 27-31 in Rome, Italy. The first results from ENSURE-AF, the largest prospective randomized clinical trial to date evaluating a non-vitamin K antagonist oral anticoagulant (NOAC) compared to a current standard of care in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion, which included nearly 2,200 patients from 19 countries, will be featured in a late-breaking clinical trial presentation. In addition, five analyses from the global phase 3 ENGAGE AF-TIMI 48 study of edoxaban (known by the brand name LIXIANA® outside the US and SAVAYSA® in the US) will be presented, including clinical outcomes associated with dose interruption in patients with NVAF compared to warfarin, relationship between body mass index and clinical outcomes, and a novel risk prediction score for net clinical outcome assessment.

Furthermore, six analyses from the PREFER in atrial fibrillation (AF) registry and one analysis from the PREFER in venous thromboembolism (VTE) registry will be presented, with new insights into the use of NOAC therapy, including prescribing patterns and trends in acute and long-term management of patients with AF and VTE.

Details of the presentations are included below:

    Presentation Title                   Presenter             
Session Details

    Late-breaking Oral Presentation

Edoxaban for Cardioversion of        Andreas Goette, MD,           
Tuesday, August 30,    
    Atrial Fibrillation: The Edoxaban    St. 
Vincenz-Hospital,         2:00-2:15 PM CET
    Versus Warfarin in 
Subjects          Paderborn, Germany            Location: Rome -

Undergoing Cardioversion of                                        
Main Auditorium
    Atrial Fibrillation (ENSURE-AF)    

    Poster Presentations
    Evolution of 
Symptoms, Rate, and     Yanish Purmah, MD,            Sunday, August 
    Rhythm Control Therapy in AF         City Hospital,          
8:30 AM-12:30 PM CET
    Patients in Europe: A Comparison     
Birmingham, United            Location:
    of the PREFER in AF and 
PREFER in    Kingdom                       Poster Area
Prolongation Data Sets                                 

Insulin-requiring Versus             Elisabetta Ricottini,         
Sunday, August 28,
    Non-insulin Requiring Diabetes       MD, 
University Campus         2:00-6:00 PM CET
    and Thromboembolic 
Risk in           Bio-Medico, Rome,             Location:

Patients with Atrial                 Italy                         
Poster Area
    Fibrillation: A PREFER in AF                         

    Registry Sub-study               

    Antithrombotic Management of
Giulia Renda, MD, PhD         Sunday, August 28,
Fibrillation: Follow-up       G. d'Annunzio University      2:00-6:00
    Data from the PREFER in AF           of Chieti-Pescara    
    Registry                             Chieti, 
Italy                 Poster Area

    The HAS-BLED Score for 
Prediction    Miklos Rohla, MD,             Sunday, August 28,
Stroke and Systemic Embolism:     Medical University of         
2:00-6:00 PM CET
    Insights from the PREvention oF      Vienna, 
Vienna, Austria       Location:
    thromboembolic  events - European
Poster Area
    Registry in Atrial 
    (PREFER in AF)

    Patients' Convenience and       
Raffaele De Caterina, MD,     Sunday, August 28,
as Important Factors    PhD, FESC, G. d'Annunzio      2:00-6:00 PM 
    Related to Switching from Vitamin    University of Chieti-   
    K Antagonists to NOACs - A PREFER    Pescara 
Chieti, Italy         Poster Area             
    in AF Registry 

    Moderated Poster Presentation

Hospitalization-Related Costs        Elizabeth A. Magnuson, ScD,    
Tuesday, August 30,
    Among Patients with Atrial           Saint 
Lukes Hospital,          10:25-10:35 AM CET
     Fibrillation Treated
with the        Kansas City, Missouri,         Location: Moderated

Factor Xa Inhibitor Edoxaban vs      United States of America       
Poster Station -
    Warfarin: Results from the ENGAGE               
Poster Area
    AF-TIMI 48 Trial                 

Rapid Fire Abstracts
    Linking Intrinsic Factor X           
Ophelia Q. Yin, Phd, FCP,      Sunday, August 28,
    Activity, a 
Biologically Relevant    Daiichi Sankyo, Edison,        11:36-11:45 
    Pharmacodynamic Marker, to           New Jersey, United   
Location: Agora 1 - 
    Edoxaban Plasma Concentration and  
States of America              Poster Area
    Clinical Outcomes in 
    AF-TIMI 48 Trial

    Gender Differences in Clinical  
Renate B. Schnabel,  MD,       Monday, August 29,

Presentation and Predictors of       MSc University Heart Center    
9:15-9:24 AM CET
    One-Year Outcomes in Atrial          Hamburg, 
Hamburg, Germany      Location: Agora 1 -
Poster Area

Relationship Between Body Mass       Giuseppe Boriani, MD, PhD,     
Tuesday, August 30,
    Index and Outcomes in 21,028         
University of Modena,          2:09-2:18 PM CET
    Patients with 
Atrial Fibrillation    Modena, Italy                  Location: Agora
2 -
    Treated with Edoxaban or Warfarin                            
Poster Area
    in ENGAGE AF-TIMI 48 Trial

    Management of 
Acute Venous           Rupert Bauersachs, MD,         Tuesday, August
    Thromboembolism in Europe -          Max Ratschow Clinic for 
5:06-5:15 PM CET                        
    Follow-up Data at 
1 Month from       Angiology, Darmstadt,          Location: Galileo -

    the PREFER in VTE Registry           Germany   
The Hub

    Young Investigator Awards 
    Clinical Events After                Ilaria 
Cavallari, MD,          Sunday, August 28,
    Interruption of 
Anticoagulation      Brigham and Women's            2:57-1:15 PM CET

in Patients With Atrial              Hospital, Boston,            
Location: Raphael -                        
    Fibrillation: A 
Subgroup Analysis    Massachusetts, United          The Hub          

    From the ENGAGE AF-TIMI 48 Trial     States of America

A Novel Risk Prediction Score in     Christina Fanola, MD,         
Sunday, August 28,
    Atrial Fibrillation for a Net        Boston 
Medical Center,         1:32-1:50 PM CET
    Clinical Outcome from 
the ENGAGE     Brookline, Boston,             Location: Galileo -

AF-TIMI 48 Randomized Clinical       Massachusetts, United          
The Hub          
    Trial                                States of 

(EdoxabaN vs. warfarin in subjectS UndeRgoing 
cardiovErsion of Atrial Fibrillation)

ENSURE-AF is a Prospective, R
andomized, Open-Label, Blinded Endpoint evaluation (PROBE), 
parallel-group phase 3b study evaluating the efficacy and safety of 
once-daily edoxaban versus enoxaparin/warfarin in patients with NVAF 
undergoing electrical cardioversion. The primary efficacy endpoint 
was the composite of stroke, systemic embolism, myocardial 
infarction, and cardiovascular mortality. The primary safety endpoint
was the composite of major and clinically-relevant non-major 
bleeding. A total of 2,199 NVAF patients undergoing electrical 
cardioversion were enrolled at 239 clinical sites across North 
America and Europe. Patients were randomized to receive edoxaban 60 
mg (or a reduced dose of edoxaban 30 mg for specific patients with 
renal impairment or low body weight or P-glycoprotein inhibitor use) 
or enoxaparin/warfarin for 28-49 days.[1] 

About the ENGAGE AF-TIMI 48 Study

The ENGAGE AF-TIMI 48 global phase 3 study investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with NVAF at moderate-to-high risk of thromboembolic events. This represented the largest and longest trial with a NOAC in patients with AF performed to date, with a median follow-up of 2.8 years. Edoxaban demonstrated non-inferiority for stroke or systemic embolism in comparison to warfarin. For the principal safety endpoint, edoxaban was found to significantly reduce major bleeding compared to warfarin.[2]

About PREFER in AF

The initial PREFER in AF registry enrolled 7,243 AF patients across 461 centres in Austria, France, Germany, Italy, Spain, Switzerland and the UK. The aim of this registry is to provide information on the characteristics and management of patients with AF with focus on prevention of thromboembolic events, specifically stroke, together with other important patient-focused considerations such as management, quality of life and treatment satisfaction of patients with AF.[3]

The Prolongation of PREFER in AF Registry was designed to extend the ongoing PREFER in AF registry to gain further insights on AF management. The extension to the PREFER in AF registry includes two additional countries (Belgium and the Netherlands). Data is being collected from 5,000 patients across 325 centres in the nine European countries.[4]


The PREFER in VTE registry enrolled patients in seven European countries, including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the real-life acute mid-term management of patients with VTE, the use of healthcare resources, and to provide data to estimate the costs for 12 months of treatment following a first-time and/or recurrent VTE diagnosis. In addition, PREFER in VTE is the first registry of its kind to capture comprehensive real-world data regarding quality of life, patient satisfaction and the economic burden of VTE treatment across Europe.[5]

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.[6]

AF is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality.[7] More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years.[8],[9] Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.[10] One in five of all strokes are as a result of AF.[9]

About VTE

VTE is an umbrella term for two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a disease caused by a blood clot found in deep veins, usually within the lower leg, thigh or pelvis, although they can occur in other parts of the body as well.[11] PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.[12]

VTE is a major cause of morbidity and mortality.[13] A 2007 study of morbidity and mortality from VTE in six European countries (France, Germany, Italy, Spain, Sweden and the UK) estimated a total of approximately 762,000 VTE episodes and a further 370,000 VTE-related deaths each year.[13] There is a high rate of recurrence after a first VTE event, which is reduced with anticoagulant treatment. Without anticoagulant treatment, approximately half of patients who experience an initial VTE event have recurrent VTE within three months.[14]

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.

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:

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.


 1. Lip, GY. A prospective evaluation of edoxaban compared to 
    warfarin in subjects undergoing cardioversion of atrial 
    fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing 
    cardiovErsion of Atrial Fibrillation (ENSURE-AF) study. Am Heart 
    J. 2015 May;169(5):597-604.
 2. Giugliano R, et al. Edoxaban versus warfarin in patients with 
    atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104.
 3. Kirchhof P, et al. Management of atrial fibrillation in seven 
    European countries after the publication of the 2010 ESC 
    Guidelines on atrial fibrillation: primary results of the 
    PREvention oF thromboembolic events - European Registry in Atrial
    Fibrillation (PREFER in AF). Europace. 2013. doi: 
 4. Prolongation PREFER in AF Registry. European Multinational 
    Prolongation Registry on Prevention of Thromboembolic Events in 
    Atrial Fibrillation. DSE-EAF-01-13. Data on file.
 5. Agnelli G, et al. The management of acute venous thromboembolism 
    in clinical practice - study rationale and protocol of the 
    European PREFER in VTE Registry. Thromb J. 2015 doi: 
 6. National Heart, Lung and Blood Institute - What is Atrial 
    Fibrillation. Available at:
    . [Last accessed: March 2016].
 7. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ.
 8. 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.
 9. 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.
10. Ball J, et al. Atrial fibrillation: Profile and burden of an 
    evolving epidemic in the 21st century. Int J Card.
11. Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) - Blood Clot
    Forming in a Vein. Centers for Disease Control and Prevention. 
    Available at: . [Last 
    accessed: March 2016].
12. Van Beek E, et al. Deep vein thrombosis and pulmonary embolism. 
    New York: John Wiley & Sons, 2009. Print.
13. Cohen A, et al. Venous thromboembolism (VTE) in Europe. Thromb 
    Haemost. 2007;98(4):756-764.
14. Kearon C. Natural history of venous thromboembolism. Circulation.
    2003;107(23 suppl 1):I-22-30. 

August 2016



Lydia Worms (Europe)

Daiichi Sankyo Europe GmbH

Communications & Product PR Europe


Original content of: Daiichi Sankyo Europe GmbH, transmitted by news aktuell

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