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			var content_array=["<p><strong>About ENGAGE AF-TIMI 48<\/strong><\/p>\r\n<p>ENGAGE AF-TIMI 48 (<strong>E<\/strong>ffective a<strong>N<\/strong>ticoa<strong>G<\/strong>ulation with Factor X<strong>A<\/strong>&nbsp;next&nbsp;<strong>GE<\/strong>neration in<strong>A<\/strong>trial&nbsp;<strong>F<\/strong>ibrillation) was a three-arm, randomized, double-blind, double-dummy, global phase 3 clinical trial comparing once-daily edoxaban with warfarin in 21,105 patients with NVAF at moderate-to-high risk of thromboembolic events at 1,393 centers in 46 countries.(2)<\/p>\r\n<p>Patients were randomized (1:1:1) to receive warfarin (n=7,036), edoxaban 60 mg (n=7,035) or edoxaban 30 mg (n=7,034). Edoxaban dosage was reduced by half if any of the following was present at randomization or during the course of the study: creatinine clearance 30-50 mL\/min, body-weight &lt; or = 60 kg, or concomitant verapamil, quinidine or dronedarone (standard dosing was resumed if the concomitant drug was discontinued and no other dose reduction factors were present). The primary efficacy outcome was the time to first adjudicated stroke or SEE. The principal safety outcome was adjudicated major bleeding. Complete information on the primary endpoint was ascertained for 99.5% of the total 56,346 patient-years of potential follow-up, with only one patient lost to follow-up. Warfarin therapy was proactively monitored throughout the trial, resulting in a median time within therapeutic range (TTR) of 68.4%. Adverse event (excluding bleeding) and discontinuation rates were similar among the three treatment groups.(2)<\/p>\r\n<p>ENGAGE AF-TIMI 48 implemented a unique, pre-specified plan to transition patients to open-label anticoagulation at the end of the trial, which resulted in a low and evenly distributed number of events post-discontinuation of study therapy. In the 30 days following the transition, the number of patients experiencing stroke or SEE was the same in all three treatment groups (n=7), while major bleeding occurred in 11 patients in the warfarin group compared to 10 and 18 patients in the edoxaban 60 mg and 30 mg treatment arms, respectively. These results demonstrate that the transition plan was effective in preventing undue risk of excessive stroke \/ SEE for edoxaban-treated subjects transitioning to a vitamin K antagonist (VKA) or a novel oral anticoagulant.(2)<\/p>\r\n<p><strong>About Atrial Fibrillation<\/strong><\/p>\r\n<p>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 1-2% of people in developed nations.(3) Stroke is the second most common cause of death worldwide, responsible for approximately 6.2 million deaths each year.(4) Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.(3) Strokes due to AF are nearly twice as likely to be fatal than strokes in patients without AF(5) and have poorer prognosis than non-AF related strokes with a 50% increased risk of remaining disabled at three months.(6)<\/p>\r\n<p><strong>About Edoxaban<\/strong><\/p>\r\n<p>Edoxaban is an investigational, oral, once-daily anticoagulant that specifically and reversibly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting.(7) The global edoxaban clinical trial program includes two phase 3 clinical trials, Hokusai-VTE(8) and ENGAGE AF-TIMI 48 (<strong>E<\/strong>ffective a<strong>N<\/strong>ticoa<strong>G<\/strong>ulation with Factor X<strong>A&nbsp;<\/strong>Next&nbsp;<strong>GE<\/strong>neration in&nbsp;<strong>A<\/strong>trial&nbsp;<strong>F<\/strong>ibrillation)(1,2), which are evaluating edoxaban, administered once-daily, for treatment and prevention of recurrence of venous thromboembolism (VTE) in patients with deep vein thrombosis (DVT) and\/or pulmonary embolism (PE), and for the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation, respectively.(1,2,8)<\/p>\r\n<p>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&reg;. Elsewhere, including Europe and the US, edoxaban is currently in phase 3 clinical development and has not been approved in any indication.9 Results from the Hokusai-VTE clinical trial were presented at the European Society of Cardiology Congress on September 1, 2013 and published in the&nbsp;<em>New England Journal of Medicine.<\/em>8,9<\/p>\r\n<p><strong>About Daiichi Sankyo&nbsp;<\/strong><\/p>\r\n<p>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:&nbsp;<a rel=\"nofollow\" href=\"http:\/\/www.daiichisankyo.com\/\" target=\"_blank\">www.daiichisankyo.com<\/a>.<\/p>\r\n<p><strong>Contact&nbsp;<br \/><\/strong>Michaela Paudler-Debus, PhD&nbsp;<br \/>Daiichi Sankyo Europe&nbsp;<br \/><a rel=\"nofollow\" href=\"mailto:michaela.paudler-debus@daiichi-sankyo.eu\" target=\"_blank\">michaela.paudler-debus@daiichi-sankyo.eu<\/a>&nbsp;<br \/>+49 89 7808 685 (office)&nbsp;<br \/>+49 176 11780966 (mobile)<\/p>\r\n<p><strong>Forward-looking statements<\/strong><\/p>\r\n<p>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.<\/p>\r\n<p><strong>References<\/strong><\/p>\r\n<p>1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ruff, C et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48).&nbsp;<em>Am Heart J<\/em>2010;160:635-41.<\/p>\r\n<p>2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Giugliano, RP et al. Edoxaban versus warfarin in patients with atrial fibrillation.&nbsp;<em>N Engl J Med.<\/em>&nbsp;2013.<\/p>\r\n<p>3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ball, J et al. Atrial fibrillation: profile and burden of an evolving epidemic in the 21st century. Int J Cardiol. 2013;167:1807&ndash;24.<\/p>\r\n<p>4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; World Health Organization. The top 10 causes of death. July 2013. Available at: who.int\/mediacentre\/factsheets\/fs310\/en\/. [Last accessed: October 2013].<\/p>\r\n<p>5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Lin, H et al. Stroke severity in atrial fibrillation.&nbsp;<em>Stroke<\/em>&nbsp;1996;27:1760&ndash;1764.<\/p>\r\n<p>6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Lamassa, M et al. Characteristics, outcome, and care of stroke associated with atrial fibrillation in Europe: data from a multicenter multinational hospital-based registry (The European Community Stroke Project).&nbsp;<em>Stroke<\/em>&nbsp;2001;32:392&ndash;8.<\/p>\r\n<p>7.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ogata, K et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers.&nbsp;<em>J Clin Pharmacol<\/em>&nbsp;2010;50:743-753.<\/p>\r\n<p>8.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Buller, H et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism.&nbsp;<em>N Engl J Med<\/em>&nbsp;2013;369:1406-15.<\/p>\r\n<p>9.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Daiichi Sankyo press release - Daiichi Sankyo launches LIXIANA&reg; (edoxaban), a direct oral factor Xa inhibitor, in Japan for the prevention of venous thromboembolism after major orthopaedic surgery. 19 July 2011. Available at: <a rel=\"nofollow\" href=\"http:\/\/www.daiichisankyo.com\/news\/detail\/004123.html\" target=\"_blank\">http:\/\/www.daiichisankyo.com\/news\/detail\/004123.html<\/a>. [Last accessed: October 2013].<\/p>"];
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