Daiichi Sankyo Initiates Phase 3 ENSURE-AF Study, Investigating Once-Daily Edoxaban in Patients with Atrial Fibrillation

Daiichi Sankyo Initiates Phase 3 ENSURE-AF Study, Investigating Once-Daily 
Edoxaban in Patients with Atrial Fibrillation Undergoing Cardioversion 
First patient enrolled in largest planned phase 3 study evaluating a novel 
oral anticoagulant in non-valvular atrial fibrillation patients undergoing 
electrical cardioversion 
PARSIPPANY, N.J., March 31, 2014 /CNW/ - Daiichi Sankyo Company, Limited 
(hereafter, Daiichi Sankyo) today announced that it has started enrolling 
patients into the ENSURE-AF multinational phase 3 study, which will evaluate 
the efficacy and safety of its investigational oral, once-daily direct factor 
Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of 
stroke and other blood clot complications in patients with non-valvular atrial 
fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to 
trigger normal heart rhythm).(1,2 )More than 2,200 patients are expected to be 
enrolled in ENSURE-AF at approximately 250 clinical sites across North America 
and Europe.(1) 
"Due to the risk of thromboembolism, clinical guidelines recommend 
anticoagulation before and after cardioversion in patients with atrial 
fibrillation," said Andreas Goette, MD, Chief Physician, St. Vincenz-Hospital 
Paderborn, Germany, Department of Cardiology and Intensive Care Medicine and 
member of the European Heart Rhythm Association's International Affairs 
Committee with responsibility for Japan.(3,4)  "This trial will provide us 
with insights on whether edoxaban can be a viable treatment option for 
non-valvular atrial fibrillation patients undergoing cardioversion."(1) 
"This is a very exciting study as this will be the largest planned clinical 
trial to evaluate a novel oral anticoagulant with the current standard of care 
in patients undergoing cardioversion," said Gregory YH Lip, Professor of 
Cardiovascular Medicine, University of Birmingham, UK. "The novel oral 
anticoagulants offer the possibility of efficacy, safety and convenience for 
the peri-cardioversion management of patients with atrial fibrillation." 
About ENSURE-AF 
ENSURE-AF is a Prospective, Randomized, Open-Label, Blinded Endpont evaluation 
(PROBE), parallel group study, evaluating the efficacy and safety of 
once-daily edoxaban for the prevention of stroke, systemic embolic event, 
myocardial infarction and cardiovascular mortality versus enoxaparin/warfarin 
in patients with NVAF undergoing electrical cardioversion. More than 2,200 
NVAF patients undergoing electrical cardioversion are expected to be enrolled 
at approximately 250 clinical sites across North America and Europe. Patients 
will be randomized to receive edoxaban 60 mg (or a patient specific dose of 
edoxaban 30 mg for patients with renal impairment or low body weight or 
p-glycoprotein inhibitor use) or enoxaparin/warfarin for 28-49 days.(1) 
For more information please visit: http://clinicaltrials.gov/show/NCT02072434. 
About Atrial Fibrillation and Cardioversion 
Atrial fibrillation (AF) is a condition in which the heartbeat is rapid and 
irregular, and can potentially lead to a stroke. AF is a common condition, 
affecting approximately 2.3-3.4% of people in developed nations.(5) Stroke is 
the second most common cause of death worldwide, responsible for approximately 
6.2 million deaths each year.(6) Compared to those without AF, people with the 
arrhythmia have a 3-5 times higher risk of stroke.(5) Strokes due to AF are 
nearly twice as likely to be fatal than strokes in patients without AF at 30 
days(7) and have poorer prognosis than non-AF related strokes, with a 50% 
increased risk of remaining disabled at three months.(8) Cardioversion is a 
procedure that can restore a fast or irregular heartbeat to a normal rhythm, 
but is associated with a risk of thromboembolic events, including stroke, in 
patients who do not receive anticoagulation therapy.(2,9) 
About Edoxaban 
Edoxaban is an investigational, oral, once-daily anticoagulant that 
specifically inhibits factor Xa, which is an important factor in the 
coagulation system that leads to blood clotting.(10) The global edoxaban 
clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and 
ENGAGE AF-TIMI 48 (Effective aNticoaGulation with factor xA next GEneration in 
Atrial Fibrillation), which included nearly 30,000 patients combined. The 
results from these trials form the basis of regulatory filings for edoxaban 
for symptomatic venous thromboembolism (VTE) in patients with deep vein 
thrombosis and/or pulmonary embolism, and for the prevention of stroke in 
NVAF, respectively.(11,12) Edoxaban is currently under regulatory review in 
Japan, the U.S. and EU for these indications. 
Edoxaban is currently approved only in Japan, since April 2011, for the 
prevention of VTE after major orthopedic surgery, and was launched in July 
2011 under the brand name Lixiana(®). Elsewhere, including Europe and the 
U.S., edoxaban has not been approved in any indication.(13) 
About Daiichi Sankyo 
Daiichi Sankyo Group is dedicated to the creation and supply of innovative 
pharmaceutical products to address the diversified, unmet medical needs of 
patients in both mature and emerging markets. While maintaining its portfolio 
of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial 
infections, the Group is engaged in the development of treatments for 
thrombotic disorders and focused on the discovery of novel oncology and 
cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has 
created a "Hybrid Business Model," which will respond to market and customer 
diversity and optimize growth opportunities across the value chain. For more 
information, please visit: www.daiichisankyo.com. 
 
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    |Global Media                                                                                                       
                                   |US Media                                                                            
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    |Michaela Paudler-Debus, PhD                                                                                        
                                   |Alyssa Dargento                                                                     
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|michaela.paudler-debus@daiichi-sankyo.eu|adargento@dsi.com| 

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    |+49 89 7808 685 (office)                                                                                           
                                   |+1 973 944 2913 (office)                                                            
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    |+49 176 1178 0966 (mobile)                                                                                         
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    |EU Media                                                                                                           
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    |Daria Munsel                                                                                                       
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    |daria.munsel@daiichi-sankyo.eu                    |                                                                
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    |+49 89 7808728 (office)                                                                                            
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    |+49 176 11780826 (mobile)                                                                                          
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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. 
References 


      1. Goette, A. Edoxaban vs. Warfarin in Subjects Undergoing
         Cardioversion of Atrial Fibrillation (ENSURE IN AF). In:
         ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of
         Medicine (US). 2000-2014. Available from
         http://clinicaltrials.gov/show/NCT02072434.
         NLM Identifier: NCT02072434.
      2. National Heart, Lung, and Blood Institute. What is Cardioversion.
         2012. Available at:
         https://www.nhlbi.nih.gov/health/health-topics/topics/crv/.
         [Last accessed: March 2014].
      3. American College of Cardiology Foundation and American Heart
         Association. ACCF/AHA pocket guideline: management of patients
         with atrial fibrillation. 2011. Available at:


     http://www.cardiosource.org/ 
/media/Files/Science%20and%20Quality/Guidelines/Pocket%20Guides/AFIB_PocketGuide.ashx. 


         [Last accessed: March 2014].
      4. Camm, J et al. Guidelines for the management of atrial
         fibrillation. Eur Heart J 2010;31:2369-2429.
      5. Ball, J et al. Atrial fibrillation: Profile and burden of an
         evolving epidemic in the 21st century. Int J Card 2013;
         167:1807-1824.
      6. World Health Organization. The top 10 causes of death. July 2013.
         Available at: who.int/mediacentre/factsheets/fs310/en/. [Last
         accessed: March 2014].
      7. Lin H et al. Stroke severity in atrial fibrillation. Stroke 1996;
         27:1760-1764.
      8. Lamassa A et al. Characteristics, outcome, and care of stroke
         associated with atrial fibrillation in Europe. Stroke 2001;
         32:392-398.
      9. Fuster, V et al. ACC/AHA/ESC guidelines for the management of
         patients with atrial fibrillation: executive summary; A report of
         the American College of Cardiology/American Heart Association Task
         Force on Practice Guidelines and the European Society of
         Cardiology Committee for Practice Guidelines and Policy
         Conferences. Circulation 2001;104:2118-2150.
     10. Ogata, K et al. Clinical safety, tolerability, pharmacokinetics,
         and pharmacodynamics of the novel factor Xa inhibitor edoxaban in
         healthy volunteers. J Clin Pharmacol 2010;50:743-753.
     11. Giugliano, R et al. Edoxaban versus Warfarin in patients with
         atrial fibrillation. N Engl J Med 2013;369:2093-2104.
     12. Büller, H et al. Edoxaban versus warfarin for the treatment of
         symptomatic venous thromboembolism. N Engl J Med 2013;
         369:1406-1415.
     13. Daiichi Sankyo press release - Daiichi Sankyo launches LIXIANA®
         (edoxaban), a direct oral factor Xa inhibitor, in Japan for the
         prevention of venous thromboembolism after major orthopaedic
         surgery. 19 July 2011. Available at:
         http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005784.html.
         [Last accessed: March 2014].



SOURCE  Daiichi Sankyo Company, Limited 
http://www.daiichisankyo.com 
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CO: Daiichi Sankyo Company, Limited
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NI: CPR ELE HEA MTC  
-0- Mar/31/2014 11:01 GMT
 
 
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