Bayer HealthCare announced today that the oral anticoagulant Xarelto® (rivaroxaban), used as a single drug intervention, was as effective and safe as the current dual drug approach of subcutaneous enoxaparin followed by Vitamin K antagonist (VKA), in treating patients with acute symptomatic pulmonary embolism (PE) and preventing them from developing a secondary venous thromboembolism (VTE).
Rivaroxaban demonstrated similar overall bleeding rates, but was associated with significantly lower rates of major bleeding versus the current standard regimen.
These data were presented today as a late-breaker at the American College of Cardiology Annual Scientific Sessions, and published in the New England Journal of Medicine.
The EINSTEIN-PE study compared the oral single-drug approach with rivaroxaban 15 mg twice daily for three weeks followed by 20 mg once daily with the current standard of care of subcutaneous enoxaparin followed by a VKA in the treatment of 4833 patients with acute symptomatic PE for the prevention of recurrent VTE. Patients received treatment for three, six or 12 months.
In the study, rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis (DVT) and non-fatal or fatal PE [2.1% vs. 1.8%, respectively (p=0.003 for non-inferiority)].
Rivaroxaban also demonstrated similar safety results compared to current standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events [10.3% vs. 11.4% (p=0.23), respectively].
Importantly, rivaroxaban treatment resulted in a significant reduction in major bleeding events [1.1% vs. 2.2% (p=0.003), respectively] compared to the current standard therapy.
“The results of the EINSTEIN-PE study convincingly demonstrate that rivaroxaban offers clinicians a simple, single-drug solution to the initial treatment of PE and the long-term prevention of recurrent VTE, which is as effective as the current dual-drug approach and equally well tolerated,” said Dr. A.G.G. Turpie, Professor of Medicine at McMaster University, Hamilton, Canada.
“These new findings are of particular importance given the appalling level of morbidity and mortality associated with venous thromboembolism in Europe and the U.S. and the frequency of recurrence”.