Daiichi Sankyo to Present Findings From New Subgroup Analyses of Once-Daily LIXIANA®▼ (edoxaban) in NVAF and VTE at ACC's 65th Annual Scientific Session

MUNICH, March 24, 2016 /PRNewswire/ --

- Four abstracts highlight new subgroup analyses from the global phase 3 ENGAGE
AF-TIMI 48 and Hokusai-VTE studies to be presented in oral and poster sessions  

Daiichi Sankyo Europe GmbH Group (hereafter, Daiichi Sankyo) today announced that data from three new subgroup analyses from the phase 3 ENGAGE AF-TIMI 48 study, and one new subgroup analysis from the phase 3 Hokusai-VTE study, will be presented at the American College of Cardiology's 65th Annual Scientific Session, April 2-4, 2016, in Chicago, Illinois. Results will provide new insights into the safety and efficacy profile of once-daily edoxaban compared to warfarin in patients with non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE).

The subgroup analysis data on edoxaban (known by the brand name LIXIANA(R)) will be presented. The complete list of presentations is included below:

Presentation Title Presenter Session Details
Oral Session

Outcomes in 2,824 Patients With Giulia Renda, MD, PhD, Monday, April 4,
Valvular Heart Disease Treated G. d'Annunzio 8:30-8:42 AM CDT
With Edoxaban or Warfarin in the University of Location: S405
ENGAGE AF-TIMI 48 Trial (ACC Chieti-Pescara,
Session #915-06) Chieti, Italy

Poster Presentations

Recurrent Venous Marjolein P.A. Sunday, April 3
Thromboembolism Brekelmans, MD 9:45-10:30 AM CDT
in Pulmonary Embolism Patients Department of Location: South
With Right Ventricular Vascular Medicine, Hall A1
Dysfunction in the Hokusai-VTE Academic Medical
Study Netherlands

Sudden Cardiac Death in 21,105 Alon Eisen, MD, Sunday, April 3
Patients With Atrial Brigham and Women's 9:45-10:30 AM CDT
Fibrillation: Insights From the Hospital, Boston, MA, Location: South
Abstract #1188-338/338)

Moderated Poster Presentation

Edoxaban Versus Warfarin in 841 Jonathan Monday, April 4
Patients With Atrial Fibrillation Cunningham, MD, 12:45-12:55 PM CDT
and Peripheral Arterial Disease: Brigham and Location: South
Insights From the ENGAGE AF-TIMI Women's Hospital, Hall A1
48 Trial (ACC Session #1289M-03) Boston, MA, USA

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. This represented the largest and longest trial with a novel oral anticoagulant (NOAC) in patients with atrial fibrillation (AF) performed to date, with a median follow-up of 2.8 years. Edoxaban demonstrated non-inferiority for stroke or systemic embolism (SE) in comparison to warfarin. Edoxaban was also found to be superior for the principal safety endpoint of major bleeding in comparison to warfarin.[1]

About the Hokusai-VTE Study 

The Hokusai-VTE global phase 3 study was the largest single comparative trial of a NOAC in patients with VTE, which evaluated once-daily edoxaban versus warfarin in 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE) or both. The Hokusai-VTE study was designed to reflect clinical practice using a flexible treatment duration of 3-12 months in a broad spectrum of VTE patients, including initial use of parenteral anticoagulant (heparin) for at least five days, the proven global standard of care. Edoxaban demonstrated non-inferiority to warfarin for the primary efficacy endpoint of recurrence of symptomatic VTE, and was found to be superior in the primary safety endpoint of clinically relevant bleeding compared to warfarin.[2]

About AF 

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]

About VTE 

VTE is an umbrella term for two conditions, DVT and 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.[8] PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.[9]

VTE is a major cause of morbidity and mortality.[10] 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.[10] 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.[11]

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 received EU approval in June 2015 for the prevention of stroke and SE 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), as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Edoxaban is currently marketed in South Korea, the Netherlands, Ireland, the UK, Germany, Switzerland, the US and Japan, and was approved in Taiwan. In other countries, regulatory review is ongoing.

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 17,000 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 its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group's research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: 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.


1) Giugliano R, et al. Edoxaban versus warfarin in patients with atrial fibrillation.
N Engl J Med. 2013;369(22):2093-2104.
2) Büller H, et al. Edoxaban versus warfarin for the treatment of symptomatic venous
thromboembolism. N Engl J Med. 2013;369(15):1406-1415.
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: March 2016].
4) Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485)
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.
8) Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) - Blood Clot Forming in a Vein.
Centers for Disease Control and Prevention. Available at:
http://www.cdc.gov/ncbddd/dvt/facts.html . [Last accessed: March 2016].
9) Van Beek E, et al. Deep vein thrombosis and pulmonary embolism. New York: John Wiley &
Sons, 2009. Print.
10) Cohen A, et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost. 2007;98(4)
11) Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107(23 suppl 1)

Kimberly Wix (U.S) 
Daiichi Sankyo, Inc. 
Senior Director, Public Affairs 

Lydia Worms (Europe) 
Daiichi Sankyo Europe GmbH 
Edoxaban Communications & Product PR Europe 


Date of prep: March 2016 


Daiichi Sankyo Company, Limited

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