title: Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform.
abstract: Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, with Medicare as primary payer. We compared observed rates of death and major cardiovascular events in 2011 and 2012 with expected rates calculated on the basis of rates in 2005-2010, accounting for differences in patient characteristics and influenza virulence. An abrupt decline in erythropoietin dosing and hemoglobin concentration began in late 2010. Observed rates of all-cause mortality, cardiovascular mortality, and myocardial infarction in 2011 and 2012 were consistent with expected rates. During 2012, observed rates of stroke, venous thromboembolic disease (VTE), and heart failure were lower than expected (absolute deviation from trend per 100 patient-years [95% confidence interval]: -0.24 [-0.08 to -0.37] for stroke, -2.43 [-1.35 to -3.70] for VTE, and -0.77 [-0.28 to -1.27] for heart failure), although non-ESA-related changes in practice and Medicare payment penalties for rehospitalization may have confounded the results. This initial evidence suggests that action taken to mitigate risks associated with ESA use and changes in payment policy did not result in a relative increase in death or major cardiovascular events and may reflect improvements in stroke, VTE, and heart failure.
authors.affiliation: Stanford University School of Medicine, Palo Alto, California; gchertow@stanford.edu.
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.affiliation: Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota.
authors.forename: Jiannong
authors.initials: J
authors.lastname: Liu
authors.affiliation: Center for Observational Research and.
authors.forename: Keri L
authors.initials: KL
authors.lastname: Monda
authors.affiliation: Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota.
authors.forename: David T
authors.initials: DT
authors.lastname: Gilbertson
authors.affiliation: University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina.
authors.forename: M Alan
authors.initials: MA
authors.lastname: Brookhart
authors.affiliation: Center for Observational Research and.
authors.forename: Anne C
authors.initials: AC
authors.lastname: Beaubrun
authors.affiliation: Stanford University School of Medicine, Palo Alto, California; Baylor College of Medicine, Houston, Texas.
authors.forename: Wolfgang C
authors.initials: WC
authors.lastname: Winkelmayer
authors.affiliation: Clinical Development, Amgen, Inc., Thousand Oak, California.
authors.forename: Allan
authors.initials: A
authors.lastname: Pollock
authors.affiliation: Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota; University of Minnesota School of Medicine, Minneapolis, Minnesota; and.
authors.forename: Charles A
authors.initials: CA
authors.lastname: Herzog
authors.affiliation: Clinical Development, Amgen, Inc., Thousand Oak, California.
authors.forename: Akhtar
authors.initials: A
authors.lastname: Ashfaq
authors.affiliation: University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina.
authors.forename: Til
authors.initials: T
authors.lastname: Sturmer
authors.affiliation: RTI Health Solutions, Research Triangle Park, North Carolina.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Rothman
authors.affiliation: Center for Observational Research and.
authors.forename: Brian D
authors.initials: BD
authors.lastname: Bradbury
authors.affiliation: Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota; University of Minnesota School of Medicine, Minneapolis, Minnesota; and.
authors.forename: Allan J
authors.initials: AJ
authors.lastname: Collins
mesh_terms: D002318:Cardiovascular Diseases / Q000401:mortality; D015331:Cohort Studies; D011307:Drug Prescriptions / Q000592:standards; D000068817:Epoetin Alfa / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D006278:Medicare; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D012051:Reimbursement Mechanisms; D006435:Renal Dialysis; D014481:United States
chemical_list: D006397:Hematinics; D000068817:Epoetin Alfa
keywords: cardiovascular events; dialysis; erythropoietin; health policy; mortality