Data from the phase III trial of an oral anticoagulant in the chronic setting demonstrates that Bayer’s oral anticoagulant Xarelto reduces the risk of potentially fatal recurring venous thromboembolism (VTE) by 82%.
Results from the EINSTEIN-Extension study, presented today at the 51st Annual meeting of the American Society of Haematology in New Orleans, demonstrate that Xarelto, when compared to placebo, reduced the risk of a recurrent VTE by 82% (RRR) [1.3% (n=8) vs. 7.1% (n=42), respectively] in patients who had been previously treated for a deep vein thrombosis (DVT) or pulmonary embolism (PE).
Recurring VTE occur in approximately 21.5%1 of the 61,0002, 3 people that suffer from a DVT each year in the UK. Following an initial blood clot, up to 10% of patients who are treated adequately with anticoagulants, still experience an additional blood clot within 12 months.
Dr Alexander Cohen, Consultant in Vascular Medicine, King’s College Hospital, London said; “The results from the EINSTEIN-Extension study provide compelling evidence for extending prophylaxis for an additional 6-12 months beyond the currently recommended 3-6 months of treatment. VTE is a major public health concern, and costs the NHS millions each year; these results will help shape its treatment, giving physicians and patients the best chance of reducing its reoccurrence and providing the health service with considerable savings.”
VTE accounts for 10% of hospital mortality and costs the NHS an estimated £640 million per year; it is estimated that a further £19 million of NHS money has been spent on litigation from patients who have developed blood clots as a result of a hospital stay or procedure.
Xarelto does not require routine monitoring (such as clotting, liver function etc) or dose adjustment and is well tolerated, with results from the study demonstrating that the rates of major bleeding, the primary safety endpoint, were low and not statistically significantly different (p=0.11) to placebo [0.7% (n=4) vs. 0.0% (n=0) for Xarelto and placebo, respectively].
A second safety endpoint of clinically relevant, non-major bleeding (e.g. nosebleed) showed a statistical difference (p<0.001) between the two groups [5.4% (n=32) vs. 1.2% (n=7) in the Xarelto and placebo arms, respectively].
Xarelto has been studied in an extensive clinical trial programme and demonstrated no evidence of compromised liver function. No cases of serious liver injury were reported in either group of the EINSTEIN-Extension study.
Xarelto is approved in the European Union for the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery.