New real world study data on reduced risk of adverse kidney outcomes for Xarelto™ compared to VKA
05 Mar 2023
Drug ApprovalClinical Result
Berlin, March 6, 2023 – In the XARENO study, Xarelto (rivaroxaban) was associated with a reduced risk of adverse kidney outcomes in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD) compared to vitamin K antagonists. All-cause mortality was also reduced; no differences were observed between groups for the composite net-clinical benefit. The final data from this study were presented at the American Congress of Cardiology’s 72nd Annual Scientific Session together with World Congress of Cardiology (ACC.23/WCC). First data from XARENO that revealed the association of Xarelto with a potential reduced risk of adverse kidney outcomes compared to VKA were presented a year ago at ACC.22.
“Previous trials evaluating NOACs vs VKAs for stroke prevention in non-valvular atrial fibrillation have excluded patients with advanced chronic kidney disease. Therefore, the clinical impact of NOACs versus VKAs in this patient population was unknown. The XARENO study results provide important evidence that can help physicians in the management of patients with atrial fibrillation and chronic kidney disease and help reduce patients’ risk of progressing to kidney failure,” said Reinhold Kreutz, Professor of Clinical Pharmacology, Charité - Universitätsmedizin Berlin, Germany.
XARENO is the first prospective observational study to evaluate the effectiveness and safety of a NOAC versus VKAs in treating patients with NVAF and advanced CKD (estimated glomerular filtration rates (eGFR) of 15-49 mL/min/1.73 m2). Avoiding worsening renal function is an important clinical consideration beyond stroke prevention when it comes to the selection of an oral anticoagulant in patients with NVAF. The XARENO study was undertaken to investigate the real-world effectiveness and safety of Xarelto compared with VKAs in this vulnerable patient group with NVAF and advanced CKD.
About XARENO
The XA inhibition in RENal patients with non-valvular atrial fibrillation Observational registry (XARENO) was an investigator initiated prospective, non-interventional, international multicenter study recruiting NVAF patients with CKD in five European countries.
Patients treated with Xarelto or VKA having estimated glomerular filtration rates (eGFR) between 15 and 49 mL/min per 1.73 m2 were eligible for inclusion. The study population comprised 764 patients in the Xarelto group and 691 in the VKA group. Patients without anticoagulation at the discretion of the attending physicians were also enrolled for explorative analysis. Pre-specified follow-up was at least 12 months with a planned extended data collection period for one up to two additional years. Propensity score overlap-weighted Cox regression was used to compare the Xarelto and VKA groups.
After a median of 2.1 years follow up, the study found that adverse kidney outcomes occurred 8.3 times per 100 patient years in the Xarelto group compared to 12.7 times in the VKA group (95% confidence interval [CI] 0.43 to 0.88, HR=0.62.) Adverse kidney outcome was defined as a composite of eGFR decline below 15 mL/min per 1.73 m2, need for chronic kidney replacement therapy or acute kidney injury.
The frequency of net-clinical benefit events - a composite of stroke or systemic embolism, major bleeding, myocardial infarction, acute coronary syndrome, or cardiovascular death - was 13.8 per 100 patient years in the rivaroxaban and 13.6 in the VKA group (95% CI 0.72 to 1.31, HR=0.97). The mortality rate (all-cause death) was 17.6 per 100 patient years in the rivaroxaban group and 21.9 in the VKA group (95% CI 0.59 to 0.98, HR=0.76).
AF is the most common sustained cardiac rhythm disorder. In AF, the upper chambers of the heart (atria) contract irregularly. As a result, blood does not flow properly, potentially allowing blood clots to form. These blood clots can break loose and travel to the brain, resulting in a stroke. Patients with AF can have a up to 5 times higher risk of stroke than those without AF. AF is frequently associated with comorbidities, including CKD.
It’s estimated that 15–20% of people with AF also have CKD. CKD is a common and potentially deadly condition that is widely underrecognized. The disease progresses silently and unpredictably, with many symptoms not appearing until CKD is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.
Previous studies have found that patients with both AF and renal impairment are at higher risk for bleeding and stroke. They are also more likely to be undertreated with oral anticoagulation than those with normal renal function.
About Rivaroxaban (Xarelto™)
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto. Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions than any other NOAC:
The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors
The treatment of pulmonary embolism (PE) in adults
The treatment of deep vein thrombosis (DVT) in adults
The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
The prevention of VTE in adult patients undergoing elective knee replacement surgery
The prevention of atherothrombotic events after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
The prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischemic events when co-administered with acetylsalicylic acid (ASA)
Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment
Thromboprophylaxis (prevention of VTE and VTE related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure
Xarelto is approved in more than 130 countries, although the approved labelling, including the number of indications may differ from country to country. Since launch in 2008, more than 114 million patients have been treated.
Rivaroxaban was discovered by Bayer and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).
Anticoagulant medicines are therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating treatment with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
To learn more about thrombosis, please visit www.thrombosisadviser.com and www.vascularadviser.com
To learn more about Xarelto, please visit www.xarelto.com
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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