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Clinical Epidemiology
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Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform

Glenn M. Chertow, Jiannong Liu, Keri L. Monda, David T. Gilbertson, M. Alan Brookhart, Anne C. Beaubrun, Wolfgang C. Winkelmayer, Allan Pollock, Charles A. Herzog, Akhtar Ashfaq, Til Sturmer, Kenneth J. Rothman, Brian D. Bradbury and Allan J. Collins
JASN October 2016, 27 (10) 3129-3138; DOI: https://doi.org/10.1681/ASN.2015111232
Glenn M. Chertow
*Stanford University School of Medicine, Palo Alto, California;
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Jiannong Liu
†Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota;
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Keri L. Monda
‡Center for Observational Research and
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David T. Gilbertson
†Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota;
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M. Alan Brookhart
§University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina;
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Anne C. Beaubrun
‡Center for Observational Research and
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Wolfgang C. Winkelmayer
*Stanford University School of Medicine, Palo Alto, California;
‖Baylor College of Medicine, Houston, Texas;
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Allan Pollock
¶Clinical Development, Amgen, Inc., Thousand Oak, California;
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Charles A. Herzog
†Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota;
**University of Minnesota School of Medicine, Minneapolis, Minnesota; and
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Akhtar Ashfaq
¶Clinical Development, Amgen, Inc., Thousand Oak, California;
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Til Sturmer
§University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina;
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Kenneth J. Rothman
††RTI Health Solutions, Research Triangle Park, North Carolina
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Brian D. Bradbury
‡Center for Observational Research and
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Allan J. Collins
†Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, Minnesota;
**University of Minnesota School of Medicine, Minneapolis, Minnesota; and
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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.

  • dialysis
  • health policy
  • erythropoietin
  • cardiovascular events
  • mortality
  • Copyright © 2016 by the American Society of Nephrology
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Journal of the American Society of Nephrology: 27 (10)
Journal of the American Society of Nephrology
Vol. 27, Issue 10
October 2016
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Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform
Glenn M. Chertow, Jiannong Liu, Keri L. Monda, David T. Gilbertson, M. Alan Brookhart, Anne C. Beaubrun, Wolfgang C. Winkelmayer, Allan Pollock, Charles A. Herzog, Akhtar Ashfaq, Til Sturmer, Kenneth J. Rothman, Brian D. Bradbury, Allan J. Collins
JASN Oct 2016, 27 (10) 3129-3138; DOI: 10.1681/ASN.2015111232

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Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform
Glenn M. Chertow, Jiannong Liu, Keri L. Monda, David T. Gilbertson, M. Alan Brookhart, Anne C. Beaubrun, Wolfgang C. Winkelmayer, Allan Pollock, Charles A. Herzog, Akhtar Ashfaq, Til Sturmer, Kenneth J. Rothman, Brian D. Bradbury, Allan J. Collins
JASN Oct 2016, 27 (10) 3129-3138; DOI: 10.1681/ASN.2015111232
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More in this TOC Section

  • Subtyping CKD Patients by Consensus Clustering: The Chronic Renal Insufficiency Cohort (CRIC) Study
  • Long-Term Exposure to Ambient PM2.5 and Increased Risk of CKD Prevalence in China
  • Association of Multiple Plasma Biomarker Concentrations with Progression of Prevalent Diabetic Kidney Disease: Findings from the Chronic Renal Insufficiency Cohort (CRIC) Study
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Cited By...

  • A Randomized Trial of Strategies Using Darbepoetin Alfa To Avoid Transfusions in CKD
  • Bundled Payment Reform and Dialysis Facility Closures in ESKD
  • Excess Deaths Attributable to Influenza-Like Illness in the ESRD Population
  • Evaluating the Evidence behind Policy Mandates in US Dialysis Care
  • Perspective: Will We Ever Know the Optimal Hgb Level in ESRD?
  • Safety of Intravenous Iron in Dialysis: A Systematic Review and Meta-Analysis
  • The Medicare Access and CHIP Reauthorization Act: Implications for Nephrology
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Keywords

  • dialysis
  • health policy
  • erythropoietin
  • cardiovascular events
  • mortality

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