Influence of Kidney Function Estimation Methods on Eligibility for Edoxaban Population Impact of the US Food and Drug Administration’s Approach for Its Product Labeling
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Non-vitamin K antagonist oral anticoagulants (NOACs) have similar to superior safety and efficacy compared with warfarin.1 The US Food and Drug Administration (FDA) issued a “black box warning” for edoxaban in atrial fibrillation (AF) patients with estimated creatinine clearance (eCrCl) >95mL/min due to concerns regarding reduced efficacy. This warning was not adopted by European or Japanese regulatory agencies. There are limited data on the prevalence and clinical characteristics of AF patients with eCrCl>95mL/min in community practice.
Data were studied from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a prospective registry of 10 135 AF patients from 176 primary care, cardiologist, and electrophysiologist outpatient US clinics. Patients were ≥18 years of age with nonreversible AF and were enrolled June 2010 through August 2011. We excluded 820 patients (8%) with missing baseline eCrCl. Patients were stratified by baseline Cockroft-Gault eCrCl. Differences between groups were assessed by Χ2 and Wilcoxon rank-sum tests, as appropriate. The Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations calculated estimated glomerular filtration rates (eGFR) for comparison to Cockroft-Gault. Written informed consent was obtained for registry enrollment. The Duke Institutional Review Board approved this study.
Among 9315 …