Abstract
BackgroundA combination of safety concerns and labeling changes impacted use of erythropoiesis-stimulating agents (ESAs) in renal anemia. Data regarding contemporary utilization in pre-dialysis chronic kidney disease (CKD) are lacking.MethodsElectronic healthcare records and medical claims data of pre-dialysis CKD patients were aggregated from a large US managed care provider (2011–13). ESA use patterns, characteristics, and outcomes of ESA-treated/untreated patients were quantified.ResultsAt baseline, 109/32,308 patients (0.3%) were ESA users. Treated patients were older, had more advanced CKD (58.8% vs 5.4% with stage 4/5 vs 3) and greater prevalence of comorbid diabetes, hypertension, heart failure, and peripheral vascular disease. An additional 266 patients initiated ESA: hemoglobin at initiation was 8–10 g/dL in 193 of these and >10 g/dL in the remainder; 61.7% had stage 4/5 CKD; prevalence of cardiovascular disease was high (50.8% heart failure; 25.2% prior myocardial infarction; 24.1% prior stroke). During follow-up, rates of death and cardiovascular events were higher in baseline ESA users and ESA naives versus non-users.ConclusionsESA use in pre-dialysis CKD patients was exceedingly rare and directed disproportionately to older, sicker patients; these patients had high rates of death and cardiovascular events. These data provide context for contemporary use of ESA in pre-dialysis CKD.
Highlights
A combination of safety concerns and labeling changes impacted use of erythropoiesis-stimulating agents (ESAs) in renal anemia
Several reports have documented rapid changes in treatment patterns of anemia for hemodialysis patients with end-stage renal disease (ESRD) shortly after these events: lower ESA doses, lower Hb levels, greater intravenous iron use [5,6,7,8,9], and increased rates of patients receiving red blood cell transfusions [5, 7]. These changes are well documented for ESRD patients, there is a paucity of data describing ESA use patterns among US patients with nondialysis-dependent chronic kidney disease (CKD)
Data from two studies reported a decrease in ESA use and Hb concentrations in pre-dialysis CKD from 2005 to 2011 [4, 10] but, to our knowledge, no study has characterized the patterns of treatment in this population after the 2011 ESA label revision
Summary
A combination of safety concerns and labeling changes impacted use of erythropoiesis-stimulating agents (ESAs) in renal anemia. In the years since the publication of the CREATE [1], CHOIR [2], and TREAT [3] clinical studies, there has been a substantial shift in anemia management for patients with chronic kidney disease (CKD). These studies raised concerns regarding erythropoiesis-stimulating agent (ESA) use, including risks of cardiovascular and thrombotic events. The US Food and Drug Administration-approved labels for ESAs were revised These changes are well documented for ESRD patients, there is a paucity of data describing ESA use patterns among US patients with nondialysis-dependent CKD.
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