Document Detail


2009: a requiem for rHuEPOs--but should we nail down the coffin in 2010?
MedLine Citation:
PMID:  20413441     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The recombinant human erythropoietins and allied proteins (epoetin alfa, attempted copies and biosimilar variants of epoetin alfa, epoetin beta, epoetin delta, epoetin zeta, epoetin theta, epoetin omega, darbepoetin alfa, and methoxy-polyethylene glycol-epoetin beta) are among the most successful and earliest examples of biotechnologically manufactured products to be used in clinical medicine. This article charts a brief history of their use in clinical medicine, mainly dealing with chronic kidney disease, paying special attention to how these agents were introduced into clinical medicine and what has happened subsequently; in 2009, there were several developments that could be regarded as a "perfect storm" in terms of the long-term use of these compounds in chronic kidney disease and oncology and, likely, elsewhere. We are now very much at a "crossroads," where mature reflection is required, because with the latest trials and meta-analyses, these therapies seem not only expensive but also very much a clinical tradeoff (increased risk of adverse effects versus a small gain in fatigue scores). How we arrived at this crossroads is a useful illustration of how easy it is, without properly designed randomized, controlled trials, to assume that clinical benefit must follow therapeutic interventions.
Authors:
David Goldsmith
Publication Detail:
Type:  Historical Article; Journal Article; Review     Date:  2010-04-22
Journal Detail:
Title:  Clinical journal of the American Society of Nephrology : CJASN     Volume:  5     ISSN:  1555-905X     ISO Abbreviation:  Clin J Am Soc Nephrol     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-10     Completed Date:  2010-08-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101271570     Medline TA:  Clin J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  929-35     Citation Subset:  IM    
Affiliation:
Renal Department, Guy's Hospital, King's Health Partners, London, United Kingdom. david.goldsmith@gstt.nhs.uk
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MeSH Terms
Descriptor/Qualifier:
Anemia / blood,  complications,  drug therapy*,  history
Biological Markers / blood
Erythropoiesis / drug effects*
Erythropoietin, Recombinant / adverse effects,  history,  therapeutic use*
Evidence-Based Medicine
Hematinics / adverse effects,  history,  therapeutic use*
Hemoglobins / metabolism
History, 20th Century
History, 21st Century
Humans
Kidney Failure, Chronic / blood,  complications,  drug therapy*,  history
Randomized Controlled Trials as Topic
Risk Assessment
Treatment Outcome
Chemical
Reg. No./Substance:
0/Biological Markers; 0/Erythropoietin, Recombinant; 0/Hematinics; 0/Hemoglobins

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


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