Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation.
Guy Aaron YoungAnthonie W A LensingPaul MonagleChristoph MaleKirstin ThelenStefan WillmannJoseph S PalumboRiten KumarIldar NurmeevKerry HegeFanny BajollePhilip ConnorHélène L HooimeijerMarcela TorresAnthony K C ChanGili KenetSusanne HolzhauerAmparo SantamaríaPascal AmedroJan Beyer-WestendorfIda MartinelliM Patricia MassicotteWilliam T SmithScott D BerkowitzStephan SchmidtVictoria PriceMartin H PrinsDagmar Kubitzanull nullPublished in: Journal of thrombosis and haemostasis : JTH (2020)
Based on this analysis and the recently documented similar efficacy and safety of rivaroxaban compared with standard anticoagulation, we conclude that bodyweight-adjusted pediatric rivaroxaban regimens with either tablets or suspension are validated and provide for appropriate treatment of children with VTE.