New Analyses Strengthen Safety of Bayer’s Xarelto® (Rivaroxaban) – the Only Single Drug Solution to Treat and Prevent Potentially Deadly Venous Bloods Clots

New pooled subanalyses1 from the Phase III EINSTEIN clinical trial programme to be presented at the XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH) further strengthen the safety of Bayer HealthCare’s novel oral anticoagulant Xarelto® (rivaroxaban) as a single- drug therapy to treat and prevent venous blood clots. These data3 also provide new insights on clinical utility in renally impared patients.
“In a pooled analysis1, we have not only shown that major bleeding was both less severe and of a shorter duration than with the traditional dual-drug approach of injectable heparin and vitamin K antagonist, but importantly, such bleeding episodes were considerably less frequent,” said Dr Alexander T. Cohen, of King’s College Hospital, London, UK and EINSTEIN investigator. “This evidence further strengthens the already favourable benefit- risk profile of rivaroxaban as single-drug therapy in this setting.”
A separate EINSTEIN pooled subanalysis3 confirms that rivaroxaban is highly effective in protecting for renally impaired patients against DVT and PE with no increase in the risk of major bleeding or need for dose adjustment.
New Analyses Strengthen Safety of Bayer’s Xarelto® (Rivaroxaban) – the Only Single Drug Solution to Treat and Prevent Potentially Deadly Venous Bloods Clots  • Subanalyses1 from EINSTEIN studies provide important insights regarding the clinical utility of Xarelto to treat and prevent potentially deadly bloods clots in the deep veins or lungs • Data1 strengthen the safety profile, findings show Xarelto has less severe major bleeds compared to the traditional dual-drug approach • Separate analysis3 confirms Xarelto as an effective therapy for renally impaired patients, with no increased risk for major bleeding and no need for dose adjustment • Xarelto has the broadest clinical experience of the novel oral anticoagulants and is the only one available for the treatment and prevention of PE and DVT
“Rivaroxaban is a renally-excreted drug and dose adjustments for patients can be required. However, this analysis3 showed a consistent safety profile in the management of venous thrombosis regardless of the patient’s renal condition,” said Professor Rupert M. Bauersachs of the Dept. Vascular Medicine, Klinikum Darmstadt, Germany, who led the analysis on behalf of the EINSTEIN Investigators. “These findings are important as renally impaired patients are at a greater risk of major bleeding.”
“These insights build on a wealth of clinical data and real-life experience with Xarelto, offering physicians further reassurance of the clinical utility of the only novel oral anticoagulant available to treat and protect patients from potentially deadly venous blood clots,” said Dr Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
Further UK data to be presented at ISTH show Xarelto is a cost-effective alternative to dual-drug therapy in the treatment of PE and secondary prevention of venous blood clots. The assessment showed Xarelto demonstrates significant cost savings and improved quality-adjusted life year (QALY) outcomes as an alternative to the standard of care.