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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.    ________________________________________________________________________________________________________________________ ________________________________________________________________________________________________________________________ ______________        |Contact                                                                                                                                                                                                                                                         |    |_______________________________________________________________________________________________________________________ ________________________________________________________________________________________________________________________ _______________|        |Global Media                                                                                                                                           |US Media                                                                                                |    |_______________________________________________________________________________________________________________________ _______________________________|________________________________________________________________________________________ _______________|        |Michaela Paudler-Debus, PhD                                                                                                                            |Alyssa Dargento                                                                                         |    |_______________________________________________________________________________________________________________________ _______________________________|________________________________________________________________________________________ _______________|  |michaela.paudler-debus@daiichi-sankyo.eu|adargento@dsi.com|   |_______________________________________________________________________________________________________________________ _______________________________|________________________________________________________________________________________ _______________|        |+49 89 7808 685 (office)                                                                                                                               |+1 973 944 2913 (office)                                                                                |    |_______________________________________________________________________________________________________________________ _______________________________|________________________________________________________________________________________ _______________|        |+49 176 1178 0966 (mobile)                                                                                                                             |+1 973 727 1604 (mobile)                              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|                                                                                                        |    |_______________________________________________________________________________________________________________________ _______________________________|________________________________________________________________________________________ _______________|        |Daria Munsel                                                                                                                                           |                                                                                                        |    |_______________________________________________________________________________________________________________________ _______________________________|________________________________________________________________________________________ _______________|        |daria.munsel@daiichi-sankyo.eu                    |                                             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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  To view this news release in HTML formatting, please use the following URL:  http://www.newswire.ca/en/releases/archive/March2014/31/c7855.html  CO: Daiichi Sankyo Company, Limited ST: New Jersey NI: CPR ELE HEA MTC