Outcomes in patients with chronic kidney disease not on dialysis receiving extended dosing regimens of darbepoetin alfa: long-term results of the EXTEND observational cohort study.
Identifieur interne : 001466 ( PubMed/Corpus ); précédent : 001465; suivant : 001467Outcomes in patients with chronic kidney disease not on dialysis receiving extended dosing regimens of darbepoetin alfa: long-term results of the EXTEND observational cohort study.
Auteurs : Jan-Christoph Galle ; Janet Addison ; Michael G. Suranyi ; Kathleen Claes ; Salvatore Di Giulio ; Alain Guerin ; Hans Herlitz ; István Kiss ; Mourad Farouk ; Nick Manamley ; Gerhard Wirnsberger ; Christopher WinearlsSource :
- Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association [ 1460-2385 ] ; 2016.
English descriptors
- KwdEn :
- MESH :
- chemical , administration & dosage : Darbepoetin alfa, Hematinics.
- drug therapy : Renal Insufficiency, Chronic.
- Adult, Aged, Aged, 80 and over, Cohort Studies, Female, Humans, Kidney Transplantation, Male, Middle Aged, Renal Dialysis, Treatment Outcome.
Abstract
Extended dosing of the erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) once biweekly or monthly reduces anaemia treatment burden. This observational study assessed outcomes and dosing patterns in patients with chronic kidney disease not on dialysis (CKD-NoD) commencing extended dosing of DA.
DOI: 10.1093/ndt/gfw047
PubMed: 27190334
Links to Exploration step
pubmed:27190334Le document en format XML
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Suranyi</name><affiliation><nlm:affiliation>Renal Unit, Liverpool Hospital, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Claes, Kathleen" sort="Claes, Kathleen" uniqKey="Claes K" first="Kathleen" last="Claes">Kathleen Claes</name><affiliation><nlm:affiliation>Department of Nephrology and Renal Transplantation, University Hospitals Gasthuisberg, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Di Giulio, Salvatore" sort="Di Giulio, Salvatore" uniqKey="Di Giulio S" first="Salvatore" last="Di Giulio">Salvatore Di Giulio</name><affiliation><nlm:affiliation>Department of Nephrology, Dialysis and Transplantation, Ospedale San Camillo-Forlanini, Rome, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Guerin, Alain" sort="Guerin, Alain" uniqKey="Guerin A" first="Alain" last="Guerin">Alain Guerin</name><affiliation><nlm:affiliation>Clinique du Mont-Louis, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Herlitz, Hans" sort="Herlitz, Hans" uniqKey="Herlitz H" first="Hans" last="Herlitz">Hans Herlitz</name><affiliation><nlm:affiliation>Department of Molecular and Clinical Medicine/Nephrology, Institute of Medicine, The Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Kiss, Istvan" sort="Kiss, Istvan" uniqKey="Kiss I" first="István" last="Kiss">István Kiss</name><affiliation><nlm:affiliation>South-Buda Nephrology Centre (Department of Nephrology-Hypertension of St Imre Teaching Hospital and B. Braun Avitum Hungary CPLC 1st Dialysis Centre), Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Farouk, Mourad" sort="Farouk, Mourad" uniqKey="Farouk M" first="Mourad" last="Farouk">Mourad Farouk</name><affiliation><nlm:affiliation>Clinical Development, Amgen (Europe) GmbH, Zug, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Manamley, Nick" sort="Manamley, Nick" uniqKey="Manamley N" first="Nick" last="Manamley">Nick Manamley</name><affiliation><nlm:affiliation>Biostatistics, Amgen Ltd, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Wirnsberger, Gerhard" sort="Wirnsberger, Gerhard" uniqKey="Wirnsberger G" first="Gerhard" last="Wirnsberger">Gerhard Wirnsberger</name><affiliation><nlm:affiliation>Department of Internal Medicine, Medical University of Graz, Graz, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Winearls, Christopher" sort="Winearls, Christopher" uniqKey="Winearls C" first="Christopher" last="Winearls">Christopher Winearls</name><affiliation><nlm:affiliation>Oxford Kidney Unit, Churchill Hospital, Oxford, UK.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27190334</idno><idno type="pmid">27190334</idno><idno type="doi">10.1093/ndt/gfw047</idno><idno type="wicri:Area/PubMed/Corpus">001466</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001466</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Outcomes in patients with chronic kidney disease not on dialysis receiving extended dosing regimens of darbepoetin alfa: long-term results of the EXTEND observational cohort study.</title><author><name sortKey="Galle, Jan Christoph" sort="Galle, Jan Christoph" uniqKey="Galle J" first="Jan-Christoph" last="Galle">Jan-Christoph Galle</name><affiliation><nlm:affiliation>Klinik für Nephrologie und Dialyseverfahren, Klinikum Lüdenscheid, Lüdenscheid, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Addison, Janet" sort="Addison, Janet" uniqKey="Addison J" first="Janet" last="Addison">Janet Addison</name><affiliation><nlm:affiliation>Amgen Ltd, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Suranyi, Michael G" sort="Suranyi, Michael G" uniqKey="Suranyi M" first="Michael G" last="Suranyi">Michael G. Suranyi</name><affiliation><nlm:affiliation>Renal Unit, Liverpool Hospital, Sydney, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Claes, Kathleen" sort="Claes, Kathleen" uniqKey="Claes K" first="Kathleen" last="Claes">Kathleen Claes</name><affiliation><nlm:affiliation>Department of Nephrology and Renal Transplantation, University Hospitals Gasthuisberg, Leuven, Belgium.</nlm:affiliation></affiliation></author><author><name sortKey="Di Giulio, Salvatore" sort="Di Giulio, Salvatore" uniqKey="Di Giulio S" first="Salvatore" last="Di Giulio">Salvatore Di Giulio</name><affiliation><nlm:affiliation>Department of Nephrology, Dialysis and Transplantation, Ospedale San Camillo-Forlanini, Rome, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Guerin, Alain" sort="Guerin, Alain" uniqKey="Guerin A" first="Alain" last="Guerin">Alain Guerin</name><affiliation><nlm:affiliation>Clinique du Mont-Louis, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Herlitz, Hans" sort="Herlitz, Hans" uniqKey="Herlitz H" first="Hans" last="Herlitz">Hans Herlitz</name><affiliation><nlm:affiliation>Department of Molecular and Clinical Medicine/Nephrology, Institute of Medicine, The Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Kiss, Istvan" sort="Kiss, Istvan" uniqKey="Kiss I" first="István" last="Kiss">István Kiss</name><affiliation><nlm:affiliation>South-Buda Nephrology Centre (Department of Nephrology-Hypertension of St Imre Teaching Hospital and B. Braun Avitum Hungary CPLC 1st Dialysis Centre), Budapest, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Farouk, Mourad" sort="Farouk, Mourad" uniqKey="Farouk M" first="Mourad" last="Farouk">Mourad Farouk</name><affiliation><nlm:affiliation>Clinical Development, Amgen (Europe) GmbH, Zug, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Manamley, Nick" sort="Manamley, Nick" uniqKey="Manamley N" first="Nick" last="Manamley">Nick Manamley</name><affiliation><nlm:affiliation>Biostatistics, Amgen Ltd, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Wirnsberger, Gerhard" sort="Wirnsberger, Gerhard" uniqKey="Wirnsberger G" first="Gerhard" last="Wirnsberger">Gerhard Wirnsberger</name><affiliation><nlm:affiliation>Department of Internal Medicine, Medical University of Graz, Graz, Austria.</nlm:affiliation></affiliation></author><author><name sortKey="Winearls, Christopher" sort="Winearls, Christopher" uniqKey="Winearls C" first="Christopher" last="Winearls">Christopher Winearls</name><affiliation><nlm:affiliation>Oxford Kidney Unit, Churchill Hospital, Oxford, UK.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association</title><idno type="eISSN">1460-2385</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Cohort Studies</term><term>Darbepoetin alfa (administration & dosage)</term><term>Female</term><term>Hematinics (administration & dosage)</term><term>Humans</term><term>Kidney Transplantation</term><term>Male</term><term>Middle Aged</term><term>Renal Dialysis</term><term>Renal Insufficiency, Chronic (drug therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Darbepoetin alfa</term><term>Hematinics</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Renal Insufficiency, Chronic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Cohort Studies</term><term>Female</term><term>Humans</term><term>Kidney Transplantation</term><term>Male</term><term>Middle Aged</term><term>Renal Dialysis</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Extended dosing of the erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) once biweekly or monthly reduces anaemia treatment burden. This observational study assessed outcomes and dosing patterns in patients with chronic kidney disease not on dialysis (CKD-NoD) commencing extended dosing of DA.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27190334</PMID><DateCreated><Year>2016</Year><Month>05</Month><Day>18</Day></DateCreated><DateCompleted><Year>2017</Year><Month>08</Month><Day>24</Day></DateCompleted><DateRevised><Year>2017</Year><Month>08</Month><Day>24</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1460-2385</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>12</Issue><PubDate><Year>2016</Year><Month>Dec</Month></PubDate></JournalIssue><Title>Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association</Title><ISOAbbreviation>Nephrol. Dial. Transplant.</ISOAbbreviation></Journal><ArticleTitle>Outcomes in patients with chronic kidney disease not on dialysis receiving extended dosing regimens of darbepoetin alfa: long-term results of the EXTEND observational cohort study.</ArticleTitle><Pagination><MedlinePgn>2073-2085</MedlinePgn></Pagination><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Extended dosing of the erythropoiesis-stimulating agent (ESA) darbepoetin alfa (DA) once biweekly or monthly reduces anaemia treatment burden. This observational study assessed outcomes and dosing patterns in patients with chronic kidney disease not on dialysis (CKD-NoD) commencing extended dosing of DA.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Adult CKD-NoD patients starting extended dosing of DA in Europe or Australia in June 2006 or later were followed up until December 2012. Outcomes included haemoglobin (Hb) concentration, ESA dosing, mortality rates and receipt of dialysis and renal transplantation. Subgroup analyses were conducted for selected outcomes.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Of 6035 enrolled subjects, 5723 (94.8%) met analysis criteria; 1795 (29.7%) received dialysis and 238 (3.9%) underwent renal transplantation. Mean (standard deviation) Hb concentration at commencement of extended dosing was 11.0 (1.5) g/dL. Mean [95% confidence interval (CI)] Hb 12 months after commencement of extended dosing (primary outcome) was 11.6 g/dL (11.5, 11.6) overall and was similar across countries, with no differences between subjects previously treated with an ESA versus ESA-naïve subjects, subjects with versus without prior renal transplant or diabetics versus non-diabetics. Weekly ESA dose gradually decreased following commencement of extended DA dosing and was similar across subgroups. The decrease in weekly DA dose was accompanied by an increase in the proportion of patients receiving iron therapy. Hb concentrations declined following changes in ESA labels and treatment guidelines. The mortality rate (95% CI) was 7.06 (6.68, 7.46) deaths per 100 years of follow-up. Subjects alive at study end had stable Hb concentrations in the preceding year, while those who died had lower and declining Hb concentrations in their last year.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Long-term, extended dosing of DA maintained Hb concentrations in patients already treated with an ESA and corrected and maintained Hb in ESA-naïve patients.</AbstractText><CopyrightInformation>© The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Galle</LastName><ForeName>Jan-Christoph</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Klinik für Nephrologie und Dialyseverfahren, Klinikum Lüdenscheid, Lüdenscheid, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Addison</LastName><ForeName>Janet</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Amgen Ltd, Cambridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Suranyi</LastName><ForeName>Michael G</ForeName><Initials>MG</Initials><AffiliationInfo><Affiliation>Renal Unit, Liverpool Hospital, Sydney, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Claes</LastName><ForeName>Kathleen</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Nephrology and Renal Transplantation, University Hospitals Gasthuisberg, Leuven, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Di Giulio</LastName><ForeName>Salvatore</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Nephrology, Dialysis and Transplantation, Ospedale San Camillo-Forlanini, Rome, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guerin</LastName><ForeName>Alain</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Clinique du Mont-Louis, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Herlitz</LastName><ForeName>Hans</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Molecular and Clinical Medicine/Nephrology, Institute of Medicine, The Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kiss</LastName><ForeName>István</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>South-Buda Nephrology Centre (Department of Nephrology-Hypertension of St Imre Teaching Hospital and B. Braun Avitum Hungary CPLC 1st Dialysis Centre), Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Farouk</LastName><ForeName>Mourad</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Clinical Development, Amgen (Europe) GmbH, Zug, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Manamley</LastName><ForeName>Nick</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Biostatistics, Amgen Ltd, Cambridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wirnsberger</LastName><ForeName>Gerhard</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Medical University of Graz, Graz, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Winearls</LastName><ForeName>Christopher</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Oxford Kidney Unit, Churchill Hospital, Oxford, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D064888">Observational Study</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>04</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Nephrol Dial Transplant</MedlineTA><NlmUniqueID>8706402</NlmUniqueID><ISSNLinking>0931-0509</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D006397">Hematinics</NameOfSubstance></Chemical><Chemical><RegistryNumber>15UQ94PT4P</RegistryNumber><NameOfSubstance UI="D000068256">Darbepoetin alfa</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Nephrology 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Version="1">18045862</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Am Soc Nephrol. 2010 Oct;21(10):1765-75</RefSource><PMID Version="1">20798262</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015331" MajorTopicYN="N">Cohort Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000068256" MajorTopicYN="N">Darbepoetin alfa</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006397" MajorTopicYN="N">Hematinics</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016030" MajorTopicYN="N">Kidney Transplantation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006435" MajorTopicYN="N">Renal Dialysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D051436" MajorTopicYN="N">Renal Insufficiency, Chronic</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">anaemia</Keyword><Keyword MajorTopicYN="N">chronic kidney disease</Keyword><Keyword MajorTopicYN="N">darbepoetin alfa</Keyword><Keyword MajorTopicYN="N">erythropoiesis-stimulating agent</Keyword><Keyword MajorTopicYN="N">extended dosing</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year><Month>12</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>02</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>5</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>8</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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