Daiichi Sankyo Announces Large-scale Registry of Venous Thromboembolism in Cancer Patients
|Monday, 13 March 2017|
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has commenced a company-initiated large-scale clinical registry for cancer patients (hereafter, Cancer-VTE Registry).
The Cancer-VTE Registry is an observational study that will enroll and follow up to 10,000 cancer patients for one year for the following purposes:
Daiichi Sankyo will continue to contribute to the treatment and recurrence prevention of VTE through this observational study.
About VTE in Cancer Patients
VTE is a generic term for deep vein thrombosis and pulmonary thromboembolism. Deep vein thrombosis is a disease in which blood clots are formed in deep veins such as those in legs, pelvis and arms. Pulmonary thromboembolism is a disease in which a part of a thrombus formed in a deep vein is liberated and flows to the lungs, occluding the pulmonary artery, resulting in a lethal situation. It is known that the incidence of VTE is significantly higher in cancer patients than in those without cancer due to various factors such as the release of a procoagulant protein from tumor tissue. In addition, treatment with chemotherapeutic agents, immunomodulators, and angiogenesis inhibitors is also known to increase the risk of developing VTE. In cancer patients who developed VTE, the risk of death from acute thrombotic events is said to be higher than in patients without cancer. In addition, cancer patients who developed VTE have a lower survival rate than cancer patients who do not develop VTE.
About VTE Anticoagulation Therapy and DOACs
Warfarin or unfractionated heparin has traditionally been used for VTE anticoagulation therapy. However since 2007, injectable preparations, such as low molecular weight heparin, have been used, and since 2014, three products, including Edoxaban, have been available in Japan as DOAC for the treatment and recurrence prevention of VTE.
About Edoxaban Clinical Research Program (ECRP)
Daiichi Sankyo is committed to expanding scientific knowledge about edoxaban, as demonstrated through our research programs evaluating its use in a broad range of cardiovascular conditions, patient types and clinical settings in atrial fibrillation (AF) and venous thromboembolism (VTE). The edoxaban clinical research program includes multiple RCTs (randomized, controlled trials), registries and non-interventional studies, with the goal of generating new clinical and real-world-data regarding its use in AF and VTE populations. Daiichi Sankyo expects that more than 100,000 patients will participate in the edoxaban clinical research program, including completed, ongoing and future research.
The RCTs include:
In addition, global and regional registry studies will provide important real-world data about the use of edoxaban and other oral anticoagulants in everyday practice, and include:
We are committed to adding to the scientific body of knowledge around edoxaban in a variety of AF and VTE patients, including those who are vulnerable.
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