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About Hokusai-VTE The full results were presented at the ESC Congress 2013 in Amsterdam and published in the New England Journal of Medicine<\/em>, demonstrating that edoxaban met the primary efficacy endpoint of non-inferiority, with a numerically lower incidence of recurrent symptomatic VTE compared to warfarin (3.2% vs. 3.5%, respectively) (HR, 0.89; 95% CI, 0.70 to 1.13; p<0.001 for non-inferiority) following initial use of heparin in both arms. Recurrent symptomatic VTE was defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in patients during the 12-month study period. Once-daily edoxaban was also found to be superior to warfarin for the pre-specified principal safety outcome of clinically relevant bleeding (8.5% vs. 10.3%, respectively) (HR, 0.81; 95% CI, 0.71 to 0.94; p=0.004 for superiority) occurring during or within three days of interrupting or stopping study treatment.(3)<\/p>\r\n The Hokusai-VTE study included a prespecified subgroup analysis of patients with either a history of cancer (n=563) or with active cancer (n=208) if long term low molecular weight heparin (LMWH) was not planned due to availability, physician judgment or patient preference. The trial excluded patients with active cancer for whom long term treatment with LMWH was anticipated.(3)<\/p>\r\n The study is named after the famous Japanese artist and painter Katsushika Hokusai.<\/p>\r\n Venous Thromboembolism in Cancer Patients In cancer patients, there is a significantly increased risk of VTE compared to the general population due to proteins released by malignant tumors that promote coagulation.(6) Studies have suggested that patients with cancers of the pancreas, lung, stomach and adenocarcinomas of unknown primary origin are at the highest risk of VTE due to the release of mucin, a protein commonly found in these types of cancers that can contribute to coagulation through the aggregation of platelets.(7,8) Certain anticancer therapies, such as chemotherapy, immunomodulatory agents and antiangiogenic agents also increase the risk of VTE in this patient population.(7)<\/p>\r\n In the general population 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 540,000 deaths each year in the EU.(9,10) 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.(11,12) In patients with cancer who develop VTE, there is a four- to eight-fold higher risk of dying after an acute thrombotic event than in patients without cancer.(7) Additionally, patients with cancer and VTE have a lower survival rate than those without VTE.(7)<\/p>\r\n About Edoxaban 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 is currently in phase 3 clinical development and has not been approved in any indication.(15)<\/p>\r\n About Daiichi Sankyo
<\/strong>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 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 three to 12 months, including initial use of heparin, the proven global standard of care, in both arms, in a broad spectrum of VTE patients, including those with cancer.(3)<\/p>\r\n
<\/strong>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.(5)<\/p>\r\n
<\/strong>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.(13) The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (E<\/strong>ffective aN<\/strong>ticoaG<\/strong>ulation with Factor XA <\/strong>Next GE<\/strong>neration in A<\/strong>trial F<\/strong>ibrillation). The results from these trials will form the basis of New Drug Applications for edoxaban for two potential indications, the 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.(3,14)<\/p>\r\n
<\/strong>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<\/a>.<\/p>\r\n