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New real-world evidence underscores low bleeding rates for Bayer’s Xarelto®


3 September, 2015  

Bayer HealthCare announced results from XANTUS, a real-world study involving over 6,500 patients across the United Kingdom and Europe. (1)

Study results demonstrated that the rates of major bleeding in patients with atrial fibrillation (AF) taking the novel oral anticoagulant (NOAC) Xarelto for stroke prevention were low in routine clinical practice and consistent with findings from the pivotal Phase III clinical trial, ROCKET-AF. (1,3) Results from XANTUS were presented at the ESC Congress 2015 and simultaneously published in the European Heart Journal.

Real-world evidence is increasingly important for physicians as it complements and expands on what is already known from clinical trials,” said XANTUS Principal Investigator Professor A John Camm, Professor of Clinical Cardiology in the Cardiovascular and Cell Sciences Research Institute at St George’s University of London. “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. XANTUS gives physicians reassurance to prescribe rivaroxaban as an effective and generally well-tolerated treatment option for both their high- and lower-risk patients with AF.

AF, an irregular heart rhythm, affects approximately 1.5 million people in the UK and costs the NHS over £1.8 billion in patient days spent in hospital beds alone. (2) People with AF are at a higher risk of having a stroke and approximately 20,000 strokes are caused by AF in the UK every year. (2) However, AF-related strokes are easiily prevented with anticoagulants and NOACs – such as Xarelto – provide a simplified treatment option compared to traditional therapies (such as warfarin).

XANTUS, the first international, prospective real-world evidence study in patients with AF with a NOAC, reaffirms the positive benefit-risk profile of Xarelto for stroke prevention in patients with AF, (1) first shown in the pivotal Phase III clinical trial ROCKET-AF. (3) The incidence of major bleeding in patients taking Xarelto was 3.6 per 100 person-years in ROCKET-AF. (3) In XANTUS, the incidence of major bleeding associated with Xarelto was 2.1 per 100 person-years. (1) While patients in ROCKET-AF were moderate to high risk with a mean CHADS2 score of 3.5, (3) patients studied in XANTUS had a lower average risk of stroke, with a mean CHADS2 score of 2.0. (1)

Bayer is committed to supporting clinicians and patients in the safe and responsible use of Xarelto,” said Dr Luis Felipe Graterol, UK Medical Director, Bayer HealthCare. “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.

XANTUS is part of the extensive study programme for rivaroxaban that is expected to include more than 275,000 patients in clinical trials and real-world studies (this includes patients on rivaroxaban, placebo or active comparator).

References:

  1. Camm AJ. XANTUS: Low rates of bleeding and stroke in a real-world prospective, observational study of patients treated with Rivaroxaban for stroke prevention in AF. Available online via The European Heart Journal, published 1 September 2015.
  2. The AF Report, 2014. Available at: http://www.preventaf-strokecrisis.org/files/files/The%20AF%20Report%2014%20April%202012.pdf. (Last accessed August 2015).
  3. Patel MR et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med 2011;365:883–91.
  4. Sources: ‘Xarelto’ patients = OS (IMS MIDAS adjusted by country and panel under coverage); SPAF/VTEx (internal calculation based on IMS NPA (USA); IMS LRx (GER, CAN, JPN), all other countries IMS MIDAS, Database MonthlySales December 2014).