Considerations and Challenges in Defining Optimal Iron... : Journal of the American Society of Nephrology (original) (raw)

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Considerations and Challenges in Defining Optimal Iron Utilization in Hemodialysis

Charytan, David M.*; Pai, Amy Barton†,‡; Chan, Christopher T.*,§; Coyne, Daniel W.*,‖; Hung, Adriana M.¶,**; Kovesdy, Csaba P.¶,††; Fishbane, Steven*,‡‡

*Renal Division and

¶Nephrology Division, Departments of Medicine and

†Pharmacy Practice, Brigham & Women’s Hospital, Boston, Massachusetts;

‡Albany College of Pharmacy and Health Sciences, Albany, New York;

§Toronto General Hospital, University Health Network, Ontario, Canada;

‖Washington University, Saint Louis, Missouri;

**Vanderbilt University Medical Center, Nashville, Tennessee;

††University of Tennessee Health Science Center, Memphis, Tennessee; and

‡‡Hofstra North Shore-LIJ School of Medicine, Great Neck, New York

Correspondence: Dr. David M. Charytan, Renal Division, Brigham & Women’s Hospital, 1620 Tremont Street, Third Floor, Boston, MA 02115. Email: [email protected]

Abstract

Trials raising concerns about erythropoiesis-stimulating agents, revisions to their labeling, and changes to practice guidelines and dialysis payment systems have provided strong stimuli to decrease erythropoiesis-stimulating agent use and increase intravenous iron administration in recent years. These factors have been associated with a rise in iron utilization, particularly among hemodialysis patients, and an unprecedented increase in serum ferritin concentrations. The mean serum ferritin concentration among United States dialysis patients in 2013 exceeded 800 ng/ml, with 18% of patients exceeding 1200 ng/ml. Although these changes are broad based, the wisdom of these practices is uncertain. Herein, we examine influences on and trends in intravenous iron utilization and assess the clinical trial, epidemiologic, and experimental evidence relevant to its safety and efficacy in the setting of maintenance dialysis. These data suggest a potential for harm from increasing use of parenteral iron in dialysis-dependent patients. In the absence of well powered, randomized clinical trials, available evidence will remain inadequate for making reliable conclusions about the effect of a ubiquitous therapy on mortality or other outcomes of importance to dialysis patients. Nephrology stakeholders have an urgent obligation to initiate well designed investigations of intravenous iron in order to ensure the safety of the dialysis population.