Decreased use of erythropoiesis-stimulating agents in pre-dialysis patients may be responsible.

DENVER—Hemoglobin (Hb) levels in patients initiating dialysis have been declining since 2007, a trend that corresponds to decreased use of erythropoiesis-stimulating agents (ESAs) in pre-dialysis patients, according to investigators.

The study, by Joe Weldon, MBA, and colleagues at DaVita Clinical Research in Minneapolis, examined data from 77,299 patients with end-stage renal disease who received 12 or more dialysis treatments in the first 30 days of dialysis. The proportion of patients entering dialysis with Hb levels below 10 g/dL increased from 32.6% in 2007 to 33.1% in 2008 and 40.8% in 2009. These year-to-year increases were significant.

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With patients presenting with lower hemoglobin levels, clinicians may have to shift their priority to anemia management, said Weldon, Associate Director of Medical Informatics.

The downward trend in progressively lower Hb is likely to continue given the current controversies in ESA use, the researchers stated.

Recent data document decreasing ESA use in recent years. For example, a recently published paper (online ahead of print) in Nephrology Dialysis Transplantation by Brian D. Bradbury, DSc, of Amgen Inc., in Thousand Oaks, Calif., and colleagues showed that ESA use in CKD patients not on dialysis declined from 60% to 46% between 2005 and 2009; during that same period, the mean dose decreased from 176 to 136 mcg/month. The largest decrease in use and dose occurred beginning in 2007, the study found.

Dr. Weldon’s team attributed the decline in ESA use to product labeling changes in 2007 that revised the indications for ESA use. These changes, which included a “black-box” warning, following the publication of findings from two major studies published in 2006. The studies, both published in The New England Journal of Medicine, are the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) and CREATE (Cardiovascular Risk Reduction in Early Anemia Treatment with Epoetin Beta) trials. In the CHOIR study, once-weekly epoetin alfa was used to achieve one of two Hb targets (11.3 and 13.5 g/L) in pre-dialysis CKD patients with anemia. The study showed that targeting an Hb level of 13.5 g/L target was associated with an increased risk of the composite end point of death, heart failure hospitalization, stroke, and myocardial infarction compared with targeting a level of 11.3 g/L. The study was terminated early as a result of these findings. The CREATE trial showed that targeting an Hb level of 13 to 15 g/dL in anemic predialysis CKD patients did not reduce their cardiovascular event rate or all-cause mortality compared with patients treated to an Hb goal of 11 to 12.5 g/dL.

A member of Dr. Weldon’s team, Mahesh Krishnan, MD, MBA, MPH, Vice President of Clinical Research, noted: “People became much more conservative in their use of ESAs.”