Bayer reports real-world data showing positive benefit-risk profile of Xarelto

Bayer has announced new real-world data from multiple countries affirming the positive risk-benefit profile of its novel oral anticoagulant Xarelto.

Data from XAPASS – a prospective observational post-authorisation study enrolling more than 11,000 patients in Japan – has confirmed low rates of stroke and major bleeding in patients with non-valvular atrial fibrillation newly-initiated with the rivaroxaban therapy in routine clinical practice.

These results were shown to be generally consistent with the findings of J-ROCKET AF, a phase III randomised clinical trial. Additional real-world insights have also been announced from national registers including 57,498 patients in Sweden, showing Xarelto delivered similar rates of major bleeds to warfarin, but with significantly lower rates of intracranial bleeding.

To date, around 50 percent of the clinical study programme of Xarelto has been comprised of real-world studies.

Dr Michael Devoy, chief medical officer and head of medical affairs and pharmacovigilance within Bayer's pharmaceuticals division, said: "As the wealth of real-world evidence on rivaroxaban continues to grow, these latest real-world insights further expand on randomised clinical trial results and provide physicians with continued confidence to use rivaroxaban in their everyday clinical practice."

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