Document Detail


The new FDA labeling for ESA--implications for patients and providers.
MedLine Citation:
PMID:  22266575     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Braden J Manns; Marcello Tonelli
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-01-19
Journal Detail:
Title:  Clinical journal of the American Society of Nephrology : CJASN     Volume:  7     ISSN:  1555-905X     ISO Abbreviation:  Clin J Am Soc Nephrol     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-02-16     Completed Date:  2012-06-12     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  101271570     Medline TA:  Clin J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  348-53     Citation Subset:  IM    
Affiliation:
Department of Medicine, University of Calgary, Calgary, Alberta, Canada. Braden.Manns@albertahealthservices.ca
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MeSH Terms
Descriptor/Qualifier:
Anemia / blood,  drug therapy*,  etiology
Biological Markers / blood
Chronic Disease
Drug Labeling*
Evidence-Based Medicine
Hematinics / adverse effects,  therapeutic use*
Hemoglobins / analysis
Humans
Kidney Diseases / blood,  complications,  therapy*
Patient Selection
Practice Guidelines as Topic
Risk Assessment
Risk Factors
Treatment Outcome
United States
United States Food and Drug Administration* / standards
Chemical
Reg. No./Substance:
0/Biological Markers; 0/Hematinics; 0/Hemoglobins
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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