Bayer backs safety of Xarelto after real-world data study
pharmafile | September 2, 2015 | News story | Research and Development | Bayer, ESC, European Society of Cardiology, Xarelto, anticoagulants, atrial fibrillation, real-word evidence, rivaroxaban
Around 96 in every 100 people treated with Bayer’s anticoagulant Xarelto do not experience any major bleeding, related side effects or death, according to the results of a major study into the use of the drug in clinical practice.
The Xantus study looked at the safety of Xarelto (rivaroxaban) for stroke prevention in 6,784 people with non-valvular atrial fibrillation in the UK, Europe and Canada. In ROCKET-AF, the Phase III trial that led to Xarelto’s approval, Xarelto had a rate of major bleeding of 0.2% a year, compared to 0.5% a year in patients taking warfarin. However concerns about the safety of this class of drug persist.
People in the Xantus study had a lower risk of stroke than people in ROCKET-AF. In the Xantus study, after a median period of exposure of one year, 96 in 100 patients had no treatment-related major bleeding, all-cause death, stroke or systemic embolism. Around 2 in 100 people taking Xarelto died, of any cause, and around the same number experienced treatment-related major bleeding. Overall 2 in 1,000 people died of major bleeding, while 7 in 1,000 people had a stroke. Some 7 in 1,000 had critical organ bleeding and 4 in 1,000 experienced bleeding in the blood vessels in the brain.
Professor John Camm is professor of clinical cardiology at St George’s University of London and the trial’s lead investigator, and presented his results at the European Society of Cardiology congress in London. He says: “Real-world evidence is increasingly important for physicians as it complements and expands on what is already known from clinical trials. XANTUS is a real-world study that does just that.
“The findings demonstrate the safety and effectiveness of rivaroxaban across a broader range of patients, specifically those at lower risk of stroke yet still in need of anticoagulation therapy. These real-world insights from XANTUS complement and expand on what we already know from clinical trials, and provide physicians with reassurance to prescribe rivaroxaban as an effective and well-tolerated treatment option for the broad range of patients with AF seen in their everyday clinical practice.”
Dr Luis Felipe Graterol, UK medical director at Bayer HealthCare, says: “Bayer is committed to supporting clinicians and patients in the safe and responsible use of Xarelto. As part of that commitment, these studies are invaluable as the real-world insights help clinicians make more informed treatment decisions in the management of AF.”
Lilian Anekwe
Related Content
Bayer and Aignostics to collaborate for AI oncology research
Bayer and Aignostics have announced that they have entered into a strategic collaboration for several …
Acesion Pharma raises €45m series B funding
Acesion Pharma has announced that it has closed an oversubscribed €45m series B financing round. …
Bayer’s cardiovascular drug shows impressive Phase III results
Bayer’s finerenone drug has been shown to significantly reduce cardiovascular death or other cardiovascular events …
