Bayer’s Rivaroxaban meets primary endpoint in long-term Phase III Einstein-DVT study


Bayer today announced that the single-drug treatment approach with oral rivaroxaban met the primary efficacy endpoint of non-inferiority in the Einstein-DVT Phase III clinical trial, showing an overall relative risk reduction compared to the current standard therapy in the treatment of deep vein thrombosis (DVT).

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 – initial enoxaparin treatment, followed by a vitamin K antagonist – rivaroxaban also conveyed a significantly improved net clinical benefit, as a pre-specified secondary outcome.

“The results of this study confirm that the 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, Bayer HealthCare 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 the drug.

The full data set from the Phase III Einstein-DVT study will be presented at the Hot Line Session at the Annual Meeting of the European Society of Cardiology (ESC), to be held on August 31st in Stockholm, Sweden, by lead investigator Harry R. Buller, Academic Medical Centre, Amsterdam, the Netherlands.