Abstract 11216: Applicability of US Food and Drug Administration Labeling for Dapagliflozin to Patients with Chronic Kidney Disease in the National Health and Nutrition Examination Survey (NHANES) 2017-2018 Data

Abstract

Introduction: Patients with chronic kidney disease (CKD) lack evidence-based therapeutic options to delay progression to end-stage kidney disease (ESKD) and reduce the risk of CV events. Dapagliflozin has been shown to reduce the risk of sustained eGFR decline, ESKD, hospitalization for heart failure, CV death and all-cause mortality, in adults with CKD at risk of progression. To determine the dapagliflozin-eligible CKD population in the US, and to understand the presence of CV comorbidities and use of key medications, NHANES was evaluated. Methods: The dapagliflozin-eligible population was extracted from NHANES 2017-2018 data. Inclusion criteria were: UACR ≥ 30 mg/g and/or an eGFR < 60 mL/min/1.73 m 2 in line with the approved indications for dapagliflozin. These patients are at risk of CKD progression, CV events and premature mortality, according to KDIGO 2012 CKD guidelines. Dialysis patients were excluded. Sampling weights were generated using NHANES analytical guidance. The data set was scaled in line with the US population. Results: NHANES data indicate that, of the adult US population, 35,422,098 individuals (14.4%) are eligible for dapagliflozin treatment. Of those eligible, 64.5% are non-Hispanic white, 13.2% are Hispanic, and 12.4% are non-Hispanic black. Non-Hispanic Asian and other races account for the remaining 10%. Among the eligible population, 22,104,903 individuals (62.6%) have hypertension, 10,998,581 (32.1%) have diabetes, 3,186,685 (9.1%) have a history of stroke, 2,755,256 (7.9%) have previous myocardial infarction, and 2,688,886 (7.7%) have heart failure. Renin-angiotensin-aldosterone system (RAAS) inhibitor therapy is used in 43% of these individuals. Conclusions: NHANES 2017-2018 data indicate a substantial dapagliflozin-eligible CKD population in the US. These patients are at risk of progression to ESKD or CV complications and could benefit from the availability of effective treatment options.