Bayer and Janssen’s Xarelto shows positive benefit-risk profile in new study

Bayer and Janssen have announced new data from a real-world study highlighting the positive benefit-risk profile of their novel oral anticoagulant Xarelto.

The REVISIT-US study analysed the performance of the drug in nearly 23,000 atrial fibrillation patients in the US, with results recently announced at the annual congress of the European Cardiac Arrhythmia Society.

Reduced rates of ischaemic stroke, accompanied by a lower incidence of intracranial haemorrhage, were observed in patients treated with Xarelto in patients with non-valvular atrial fibrillation when compared to warfarin.

These findings complemented and reaffirmed those seen in the phase III ROCKET AF clinical trial, as well as the non-interventional XANTUS study.

Dr Michael Devoy, chief medical officer and head of medical affairs and pharmacovigilance of Bayer's pharmaceuticals division, said: "We are pleased that study after study, evaluating Xarelto in the real world across the spectrum of approved indications continues to confirm the positive benefit-risk profile of Xarelto."

The European Medicines Agency confirmed the positive risk-benefit profile of Xarelto in stroke prevention among patients with atrial fibrillation earlier this year.