Bayer’s Rivaroxaban Meets Primary Endpoint in Long-Term Phase III EINSTEIN-DVT Study
Bayer announced that a novel, convenient single-drug treatment approach with oral rivaroxaban met the primary efficacy endpoint of non-inferiority in the EINSTEIN-DVT Phase III clinical trial and showed an overall relative risk reduction compared to the current standard therapy in the treatment of deep vein thrombosis (DVT) – initial enoxaparin treatment, followed by a vitamin K antagonist. The primary efficacy outcome in this non-inferiority trial involving more than 3,400 patients was the cumulative incidence of symptomatic recurrent venous thromboembolism (non-fatal or fatal).
Compared to standard therapy rivaroxaban conveyed a significantly improved net clinical benefit, a pre-specified secondary outcome defined as the composite of the primary efficacy endpoint plus major bleeding.
“The results of this study confirm that the novel, convenient single drug treatment approach with rivaroxaban could replace the current standard therapy in the treatment of patients suffering from deep vein thrombosis,” said Kemal Malik, M.D., member of the Executive Committee of Bayer HealthCare and Chief Medical Officer.
Rivaroxaban was well tolerated and the rate for the composite of major and clinically relevant non-major bleeding, the primary safety outcome of the study, was similar to current standard therapy. Overall safety findings in this long-term trial are in line with existing clinical data and once again confirm the good benefit/risk profile for rivaroxaban.
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