Clinical data for Bayer’s Xarelto® presented at ISTH 2015

Analyses from the EINSTEIN Clinical Trial Programme provide further data regarding the positive benefit-risk profile of Xarelto in specific patient populations. (1)

Observational data from independent study in the UK provide real life insights into the risk of VTE in patients with active cancer. (1)

Bayer HealthCare announced that new clinical data on its oral Factor Xa inhibitor Xarelto® (rivaroxaban) along with further real life insights will be presented at the XXVth Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Toronto, Canada, June 20–25 2015 providing physicians with a broader understanding of blood clot management in everyday clinical practice. Notable presentations at ISTH 2015 include:

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• Analyses of Xarelto in Various Patient Populations at Risk of Venous Blood Clots
  • Six oral presentations on sub-analyses from the EINSTEIN Clinical Trial Programme provide further insights into the use of Xarelto in specific patient populations. (1)
• Real Life Evidence Providing Insights on Blood Clot Management beyond Phase III Clinical Trials
  • Six presentations offer real life insights on blood clot management in everyday clinical practice including a non-interventional study evaluating treatment safety, an observational study in patients with cancer and an independent patient Registry exposing treatment patterns. Real life data are important as they provide additional insights beyond what is investigated in clinical trials and better represent the diverse patient populations being treated in everyday clinical practice. (2)
  • Two oral presentations and one poster presentation on an independent UK observational VTE Epidemiology Group (VEG) study offer real life insights into the burden and mortality of VTE in patients with active cancer. (1)

These real life data provide insights on the unmet medical need in this patient population. Efforts are needed to prevent and treat VTE and reduce the risk of VTE recurrences in patients with active cancer.

Additionally, two oral presentations from the independent GARFIELD-AF Registry (Global Anticoagulant Registry in the FIELD) will provide new real life data in stroke prevention in patients with newly diagnosed atrial fibrillation (AF) and one or more additional investigator determined risk factors for stroke. (1)

GARFIELD-AF, an observational, multicentre Registry, is an academic research initiative, led by the Thrombosis Research Institute (TRI) and a multidisciplinary Steering Committee, supported by an unrestricted educational grant from Bayer Pharma AG.

References:

1. Abstract Symposium. 2015 International Society on Thrombosis and Haemostasis 13 (Suppl 2) (2015) 1–997.
2. ABPI. The Vision for Real World Data – Harnessing the Opportunities in the UK. Demonstrating Value with Real World Data. September 2011.
3. Xarelto® Summary of Product Characteristics as approved by the European Commission.
4. IMS Health MIDAS Database: Monthly Sales October 2014.