| The new FDA labeling for ESA--implications for patients and providers. | |
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MedLine Citation:
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PMID: 22266575 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Braden J Manns; Marcello Tonelli |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2012-01-19 |
Journal Detail:
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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:
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Created Date: 2012-02-16 Completed Date: 2012-06-12 Revised Date: 2013-05-22 |
Medline Journal Info:
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Nlm Unique ID: 101271570 Medline TA: Clin J Am Soc Nephrol Country: United States |
Other Details:
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Languages: eng Pagination: 348-53 Citation Subset: IM |
Affiliation:
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Department of Medicine, University of Calgary, Calgary, Alberta, Canada. Braden.Manns@albertahealthservices.ca |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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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