Hemoglobin Levels Decline After ESA Label Changes
ORLANDO, Fla.—Erythropoiesis-stimulating agent (ESA) label changes have led to a decrease in mean population hemoglobin (Hb) levels as well as an increase in transfusion rates in end-stage renal disease (ESRD) patients, according to data presented at the NKF 2013 Spring Clinical Meetings.
Researchers led by Scott Sibbel, MPH, PhD, and colleagues at DaVita Clinical Research in Minneapolis, Minn., studied electronic medical records from January to October 2011 at a large dialysis organization to see if FDA revisions to ESA label language released on June 24, 2011 had any effect on Hb concentrations and transfusion rates.
After the label changes, mean Hb levels declined from 11.4 g/dL in June 2010 to 10.7 g/dL in April 2012. In addition, a larger proportion of patients had Hb levels below 10 g/dL. The proportion of patients with an Hb level below 10 g/dL was 9.64% in October 2010 (the low) and 24.25% in October 2011 (the high), according to the researchers. In addition, transfusion rates among the patients had increased. They observed no change in transfusion triggers after the label change for in-patient dialysis.
“Among many risk factors, Hb was the most notable risk factor for patient transfusion during a hospitalization event prior to and after the label change and accounted for most of the transfusion risk in multivariate models,” the authors wrote in a poster presentation.