Einstein Choice shows rivaroxaban effect in recurrent venous thromboembolism

Bayer AG and Janssen Pharmaceuticals reported results from a study called Einstein Choice on Saturday.

The study was designed to show if both 10 mg and 20 mg once-daily dosages of 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). It showed it does.

Both rivaroxaban dosages demonstrated comparable and low major bleeding rates (the principal safety outcome) on the same level as aspirin therapy.

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.”