Results from the phase III EINSTEIN-Jr. study showed a strong efficacy and safety profile of rivaroxaban in children with VTE, with results similar to those seen in previous studies in adults. Recurrent venous thromboembolism occurred at a low incidence with a numerical reduction of events in children treated with rivaroxaban compared with standard of care (heparins alone or in combination with a vitamin K antagonist such as warfarin). Major bleeding was not observed in the rivaroxaban group.[i]Children received rivaroxaban as tablets or as a newly-developed suspension for oral use. The findings from EINSTEIN-Jr. were presented as a late breaker at the 27th International Society on Thrombosis and Haemostasis Congress (ISTH) in Melbourne, Australia today.
“Current treatment of VTE in children often relies on parenteral administration of anticoagulants and requires laboratory monitoring and dose adjustments. Up to now, pediatric anticoagulant treatment regimens were based mostly on observational data and on extrapolation of data obtained in adults. The EINSTEIN-Jr. study represents an important step forwards for the treatment of VTE in children,” said Professor Christoph Male, from the Department of Pediatrics, Medical University of Vienna in Austria.
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