Bayer AG and its development partner Janssen Pharmaceuticals, Inc. have announced results from the EINSTEIN CHOICE study, which demonstrated that both 10 mg and 20 mg once-daily dosages of its oral Factor Xa inhibitor rivaroxaban (Xarelto®) significantly reduced the risk of recurrent venous thromboembolism (VTE) compared with aspirin 100 mg once daily (acetylsalicylic acid, ASA) in patients who had previously completed 6 to 12 months of anticoagulation therapy for pulmonary embolism (PE) or symptomatic deep vein thrombosis (DVT). Importantly, patients with a definitive need for continued therapeutic anticoagulation beyond the first 6 to 12 months were not included in the study. Rivaroxaban 20 mg once daily (already approved treatment regimen) significantly reduced the risk of recurrent VTE by 66% (relative risk reduction) compared with aspirin 100 mg once daily, whilst rivaroxaban 10 mg once daily significantly reduced the risk of recurrent VTE by 74% (relative risk reduction) compared with aspirin 100 mg once daily. Both rivaroxaban dosages demonstrated comparable and low major bleeding rates (the principal safety outcome) on the same level as aspirin therapy. Results from EINSTEIN CHOICE were presented today at 8 am EDT as a Late-Breaking Clinical Trial at the American College of Cardiology (ACC) 66th Annual Scientific Session in Washington DC and were simultaneously published in The New England Journal of Medicine. Data from EINSTEIN CHOICE have been submitted to the European Medicines Agency (EMA) and will be submitted to other Health Authorities worldwide during the first half of 2017.
Venous thromboembolism, which includes pulmonary embolism and deep vein thrombosis, is the third most common cause of cardiovascular death after heart attack and stroke. In patients with VTE, anticoagulation therapy is recommended for 3 months or longer, depending on the balance between the risk of recurrent VTE and the risk of bleeding.
"In patients with unprovoked VTE or with ongoing risk factors, the risk of recurrence is up to 10% in the first year if anticoagulation therapy is stopped after 3, 6 or 12 months. But many physicians are reluctant to continue anticoagulation therapy for longer durations because they are uncertain of the benefit-risk balance for individual patients," said Jeffrey Weitz, Professor of Medicine and Biochemistry and Biomedical Sciences, McMaster University, and Executive Director of the Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada and Co-Chair of the EINSTEIN CHOICE Study. "The findings from EINSTEIN CHOICE demonstrated exactly what the study name promised: once approved, rivaroxaban 10 mg once daily will be available to physicians as an additional choice in their armamentarium against recurrent VTE alongside the already approved 20 mg once-daily dose. This flexibility of choices in rivaroxaban doses will then enable physicians to use a precision approach to selecting the most appropriate extended treatment based on assessment of individual patient characteristics."
"EINSTEIN CHOICE is another example of Bayer's commitment to help answer important medical questions that arise in daily clinical practice," said Dr Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Development. "The EINSTEIN Clinical Development Programme, including not only EINSTEIN CHOICE but also EINSTEIN PE, EINSTEIN DVT, and EINSTEIN EXTENSION, has demonstrated the clinical utility of rivaroxaban in the treatment and secondary prevention of venous thromboembolism. These new data from EINSTEIN CHOICE add important additional insights on how best to provide extended protection for patients with a VTE."
Also presented today during the same Late-Breaking Clinical Trials session at ACC.17 and published simultaneously in The Lancet were results from the GEMINI ACS 1 study - a double-blind Phase II study, which randomised 3,037 patients with a recent ACS across 292 sites from 21 countries. The study met its primary endpoint by showing that the combined antithrombotic regimen of rivaroxaban 2.5 mg twice daily in addition to background therapy of clopidogrel or ticagrelor resulted in comparable rates of non-CABG TIMI clinically significant bleeding as aspirin 100 mg once daily in combination with clopidogrel or ticagrelor. Although the rates of the exploratory composite efficacy ...
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