2011 Top Game Changers in Nephrology

George Bakris, MD; Jeffrey S. Berns, MD; Lynda A. Szczech, MD; Carol Peckham

Disclosures

November 16, 2011

In This Article

3. ESA Therapy for Kidney Patients: Is It Ever Safe?

In July 2011, the US Food and Drug Administration (FDA) changed the package inserts for erythropoietin-stimulating agent (ESA) therapy.[10] The new black box warnings pointed out that hemoglobin levels above 11 g/dL in CKD and dialysis patients have been associated with death, cardiovascular risk, and stroke. No safe level of hemoglobin or safe dose of ESA has been established in these patients. The new FDA recommendations in the package insert initiate ESA therapy in patients with CKD when the hemoglobin is below 10 g/dL and stop or reduce ESA therapy dosing when the hemoglobin level is above 10 g/dL. In dialysis patients, a 10- to 11-g/dL hemoglobin range has been recommended, with initiation of therapy when the hemoglobin falls below 10 g/dL. Most of this information is extrapolated from the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).[11] In his Medscape commentary, Jeffrey Berns expressed some concern about what is going to be happening to patients, particularly those who don't closely reflect the patient populations that participated in the most recent clinical trials, and especially the young patients and relatively healthy patients without extensive comorbidity.

Watch the complete commentary from Jeffrey Berns, MD, and also the cross-Atlantic Skype debate between Ajay Singh, MD, and Francesco Locatelli, MD, on lowering the hemoglobin target.

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