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New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to vitamin K antagonists.- Bayer

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Published:9th Mar 2023

In the prospective observational XARENO study , after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD), compared to vitamin K antagonists (VKA).

 

XARENO evaluated the impact of Xarelto in patients with NVAF and CKD, given that VKAs are associated with worsening of renal function compared to non-vitamin K antagonist oral anticoagulants (NOACs)

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.

The study adds to the evidence obtained in the randomized controlled ROCKET-AF study and supports the use of Xarelto in this patient group, including the cautious use for patients with CKD stage 4 (the use of Xarelto is not recommended in patients with creatinine clearance less than 15 ml/min). Consistent with previous data indicating various benefits of rivaroxaban over VKAs on kidney outcomes, XARENO also revealed that Xarelto was associated with a reduced risk of progression to CKD stage 5 or the initiation of chronic kidney replacement therapy. With XARENO and previous studies like ANTENNA Xarelto is the only NOAC that provides such broad evidence on the reduction of adverse kidney outcomes compared to VKA.

Condition: AF and CKD
Type: drug

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