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

Research output: Contribution to journalArticlepeer-review

46 Scopus citations

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, cardiovascularmortality, andmyocardial 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]: 20.24 [20.08 to 20.37] for stroke, 22.43 [21.35 to 23.70] for VTE, and 20.77 [20.28 to 21.27] 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.

Original languageEnglish (US)
Pages (from-to)3129-3138
Number of pages10
JournalJournal of the American Society of Nephrology
Volume27
Issue number10
DOIs
StatePublished - 2016

Bibliographical note

Funding Information:
We applied to and received approval from the Human Subjects Research Committee of the Hennepin County Medical Center/Hennepin Healthcare System, Inc. Financial support was provided by Amgen, Inc.

Funding Information:
Several of the authors report receiving research grants from the National Institutes of Health and the Agency for Healthcare Research and Quality. Dr. Chertow serves on the Board of Directors of Satellite Healthcare, has served as a scientific advisor to Akebia, Amgen, Inc., Keryx, and Vifor, and has received research support from Amgen, Inc. Drs. Monda, Beaubrun, Pollock, and Bradbury work at Amgen, Inc. and hold Amgen, Inc. stock. Dr. Ashfaq worked at Amgen, Inc. at the time of manuscript submission and is currently employed at AstraZeneca. Dr. Gilbertson has provided consultation to Amgen, Inc., DaVita Clinical Research, and Affymax. Drs. Gilbertson, Collins, Herzog, and Liu work at the Chronic Disease Research Group, which has received research support from Amgen, Inc. Dr. Collins has provided consultation to NxStage, AstraZeneca, Relypsa, and Amgen. Dr. Herzog has served as a scientific consultant for Abbvie, Affymax, Amgen, Inc., BMS, Fibrogen, GSK, Keryx, Matinas Bio Pharma, Medtronic, Relypsa, ZS Pharma, and ClearView Health-carePartners, and owns stock in Boston Scientific, Johnson & Johnson, General Electric, and Merck. Dr. Brookhart has received research support from Am-gen, Inc. and AstraZeneca, has served as a scientific advisor for Amgen, Inc., GlaxoSmithKline (GSK), and Merck (honoraria/payment received by the institution), and has received consulting fees from RxAnte, Inc. and World Health Information Consultants. Dr. Stürmer receives salary support as Director of the Comparative Effectiveness and Research (CER) Strategic Initiative, North Carolina Translational and Clinical Sciences (NC TraCS) Institute, and as Director of the Center for Pharmacoepidemiology (current members: GSK, UCB BioSciences, Merck) and research support from pharmaceutical companies (Amgen, Inc., AstraZeneca) to the Department of Epidemiology, University of North Carolina at Chapel Hill. Dr. Stürmer owns stock in Novartis, Roche, BASF, AstraZeneca, Johnson & Johnson, and Novo Nordisk. Dr. Winkelmayer reports having received honoraria for having served on scientific advisory, event adjudication, or data safety monitoring boards for Akebia, Amgen, Inc., AstraZeneca, Bayer, Medtronic, Relypsa, and Zoll. Dr. Rothman is a full time employee of the Research Triangle Institute, an independent non-profit research organization that does work for government agencies and pharmaceutical companies.

Publisher Copyright:
Copyright © 2016 by the American Society of Nephrology.

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