Hemoglobin Levels Declining in CKD Patients on ESAs

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Study findings and drug label changes may be influencing nephrologists' prescribing patterns .

ORLANDO, Fla.—Hemoglobin (Hb) levels in non-dialysis CKD patients treated with erythropoiesis-stimulating agents (ESAs) have been on the decline, according to researchers. Possible reasons for the trend include changes to ESA labeling and the publication of studies challenging the value of higher Hb targets, which may have influenced how nephrologists manage CKD anemia.

In these patients, mean Hb levels declined significantly from 11.7 g/dL in January 2006 to 11.2 g/dL in December 2008. The results were consistent when stratified by gender, age, and CKD stage. During the study period, the proportion of patients with an Hb level above 12 g/dL decreased from 37.7% to 22.9%; the proportion of subjects with an Hb level of 10-12 g/dL rose from 51.6% to 62.8%; the proportion of those with an Hb level below 10 g/dL increased from 10.7% to 14.3%.

The findings are based on an analysis of data from 493 patients in the Fresenius Medical Care-North America (FMC-NA) CKD Data Registry, which includes observational information from outpatient nephrology practices. Researchers reported study findings here at the National Kidney Foundation's 2010 Spring Clinical Meetings.

“This observational analysis of practice patterns highlights the nature of clinical decision-making and how it may be influenced by both clinical evidence and public discussion of a given topic,” said lead investigator Franklin W. Maddux, MD, of FMC-NA, which has headquarters in Waltham, Mass.

The 36-month observation period precedes and follows ESA drug labeling changes in March and November 2007—which revised the indications for ESA use—and the publication in November 2006 of two major studies revealing no clinical benefit from higher Hb targets in CKD patients.

The two 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 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 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.
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