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      Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform

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          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.

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          Author and article information

          Journal
          J Am Soc Nephrol
          J. Am. Soc. Nephrol
          jnephrol
          jnephrol
          ASN
          Journal of the American Society of Nephrology : JASN
          American Society of Nephrology
          1046-6673
          1533-3450
          October 2016
          25 February 2016
          : 27
          : 10
          : 3129-3138
          Affiliations
          [* ]Stanford University School of Medicine, Palo Alto, California;
          []Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota;
          []Center for Observational Research and
          []Clinical Development, Amgen, Inc., Thousand Oak, California;
          [§ ]University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina;
          []Baylor College of Medicine, Houston, Texas;
          [** ]University of Minnesota School of Medicine, Minneapolis, Minnesota; and
          [†† ]RTI Health Solutions, Research Triangle Park, North Carolina
          Author notes
          Correspondence: Dr. Glenn M. Chertow, Stanford University School of Medicine, 1070 Arastradero Road, Suite 313, Palo Alto, CA 94034. Email: gchertow@ 123456stanford.edu
          Article
          PMC5042674 PMC5042674 5042674 2015111232
          10.1681/ASN.2015111232
          5042674
          26917691
          b14c9cf9-7434-4eb6-9e11-4d3edded05f3
          Copyright © 2016 by the American Society of Nephrology
          History
          : 15 November 2015
          : 10 January 2016
          Page count
          Figures: 4, Tables: 1, Equations: 0, References: 31, Pages: 10
          Categories
          Clinical Epidemiology
          Custom metadata
          October 2016

          dialysis,health policy,erythropoietin,cardiovascular events,mortality

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