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			var content_array=["<p><strong>About Hokusai-VTE <\/strong><\/p>\r\n<p>Hokusai-VTE was a global, event-driven, randomized, double-blind, parallel-group phase 3 clinical study involving 8,292 patients in 439 clinical sites across 37 countries to evaluate once-daily edoxaban in patients with symptomatic DVT and\/or PE.(1)<\/p>\r\n<p>Patients were randomized to one of two different treatment groups. Both groups received open-label enoxaparin or unfractionated heparin for at least five days, and either warfarin or placebo (administered to edoxaban group), followed by double-blind edoxaban 60 mg (n=4,118) (edoxaban 30 mg for patients with renal impairment or low body weight or p-glycoprotein inhibitor use) or warfarin (n=4,122) for at least three months and up to a maximum of one year (duration of study treatment was determined by the investigator based on the patient's clinical features). Patients were followed for 12 months regardless of treatment duration to provide investigators with a better understanding of outcomes in clinical practice relative to an on-treatment analysis only. (1)<\/p>\r\n<p>The primary efficacy outcome was the recurrence of symptomatic VTE, defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in patients during the 12-month study period. The principal safety outcome was clinically relevant bleeding (major or non-major) occurring during or within three days of interrupting or stopping study treatment. Secondary efficacy outcomes included the composite clinical outcome of symptomatic recurrent DVT, non-fatal symptomatic recurrent PE and all-cause mortality.(1)6<\/p>\r\n<p>The study is named after the famous Japanese artist and painter Katsushika Hokusai.<\/p>\r\n<p><strong>About Venous Thromboembolism<\/strong><\/p>\r\n<p>VTE is an umbrella term for two conditions, DVT and PE. DVT is a blood clot found anywhere in the deep veins of the legs, while PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.(2)<\/p>\r\n<p>VTE is a major cause of morbidity and mortality worldwide with an annual incidence of approximately one per 1,000 in developed countries, including an estimated 430,000 PE events, 680,000 DVT events and 40,000 deaths each year in the EU.(3,4) In the U.S., it is currently estimated that more than 950,000 VTE events and approximately 300,000 VTE related deaths occur each year.(5,6) Thirty percent of people with VTE die within one month of diagnosis and about 20% of those with PE experience sudden death. (7)<\/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. (8) The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (<strong>E<\/strong>ffective a<strong>N<\/strong>ticoa<strong>G<\/strong>ulation with Factor X<strong>A <\/strong>Next <strong>GE<\/strong>neration in <strong>A<\/strong>trial <strong>F<\/strong>ibrillation), 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. (9)<\/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 U.S., edoxaban is currently in phase 3 clinical development and has not been approved in any indication.(10) Results from the ENGAGE AF-TIMI 48 study will be presented at the American Heart Association Scientific Sessions on November 19th, 2013.<\/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: <a href=\"http:\/\/www.daiichisankyo.com\/\" target=\"_blank\">www.daiichisankyo.com<\/a>.<\/p>\r\n<p><strong>Contact<br \/> <\/strong>Michaela Paudler-Debus, PhD <br \/> Daiichi Sankyo Europe <br \/> <a href=\"mailto:michaela.paudler-debus@daiichi-sankyo.eu\" target=\"_blank\">michaela.paudler-debus@daiichi-sankyo.eu<\/a> <br \/> +49 89 7808 685 (office) <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. Buller, H et al. Edoxaban versus Warfarin for the treatment of Symptomatic Venous Thromboembolism.<\/p>\r\n<p><em>N Engl J Med<\/em>. 2013.<\/p>\r\n<p>2.&nbsp;Van Beek, E et al. <em>Deep Vein Thrombosis and Pulmonary Embolism<\/em>. New York: John Wiley &amp; Sons, 2009. Print.<\/p>\r\n<p>3.&nbsp;Bramlage P, Pittrow D, Kirch,W. <em>European Journal of Clinical Investigation<\/em>. 2005; 35 (Suppl. 1):4-11.<\/p>\r\n<p>4.&nbsp;Cohen A, Agnelli G, Anderson F. Venous thromboembolism (VTE) in Europe. Thromb Haemost 2007; 98: 756&ndash;764.<\/p>\r\n<p>5.&nbsp;Deitelzweig S, Lin J, Johnson BH, Schulman KL. Prevalence of venous thromboembolism in the USA: now and future.<\/p>\r\n<p>Thromb Haemost 2009;7 (Suppl. 2):207-8 (abstract OC-WE-018).<\/p>\r\n<p>6.&nbsp;Heit JA, Cohen AT, Anderson FAJ, on behalf of the VTE Impact Assessment Group. Estimated annual number of incident and recurrent, non-fatal and fatal venous thromboembolism (VTE) events in the US. ASH Annual Meeting Abstracts. 106:910. 2005.<\/p>\r\n<p>7.&nbsp;Heit JA. Venous thromboembolism epidemiology: implications for prevention and management. <em>Seminars in Thrombosis and Hemostasis<\/em>. 2002;(s2):003&ndash; 014.<\/p>\r\n<p>8.&nbsp;Ogata, K et al. Clinical Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers. <em>J Clin Pharmacol<\/em>. 2010;50:743-753.<\/p>\r\n<p>9.&nbsp;Ruff CT 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). <em>Am Heart J<\/em>. 2010; Oct;160(4):635-41.<\/p>\r\n<p>10.&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: http:\/\/www.daiichisankyo.com\/news\/detail\/004123.html. [Last accessed: July 2013].<\/p>"];
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