title: The new FDA labeling for ESA--implications for patients and providers.
abstract: Recent clinical trials comparing the use of erythropoiesis-stimulating agents targeting low (generally a hemoglobin of 90-115 g/L) and near-normal hemoglobin targets (generally a hemoglobin >130 g/L) in patients with chronic kidney disease have shown no improvements in clinical outcomes (aside from a small reduction in transfusion) and potential harm for erythropoiesis-stimulating agents use targeting near-normal hemoglobin targets. Based on these results, the US Food and Drug Administration recently released modified recommendations for more conservative dosing of erythropoiesis-stimulating agents in patients with CKD. These recommendations now stress individualizing therapy for each patient and using the lowest possible erythropoiesis-stimulating agents dose required to reduce the need for transfusions. The evolution in the management of anemia associated with chronic kidney disease over time and the recent evidence that has stimulated these labeling changes is discussed. Also, the US Food and Drug Administration labeling changes are discussed, and areas of controversy are highlighted. Although the US Food and Drug Administration labeling changes are based on the results of recent large randomized trials testing ESAs targeting near-normal hemoglobin levels, more specific guidance to clinicians would have been helpful.
authors.affiliation: Department of Medicine, University of Calgary, Calgary, Alberta, Canada. Braden.Manns@albertahealthservices.ca
authors.forename: Braden J
authors.initials: BJ
authors.lastname: Manns
authors.forename: Marcello
authors.initials: M
authors.lastname: Tonelli
mesh_terms: D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D015415:Biomarkers / Q000097:blood; D002908:Chronic Disease; D004348:Drug Labeling; D019317:Evidence-Based Medicine; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000628:therapy*; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins