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Evolution of the absorption profile of cyclosporine A in renal transplant recipients: a longitudinal study of the de novo and maintenance phases.

Identifieur interne : 003C20 ( PubMed/Corpus ); précédent : 003C19; suivant : 003C21

Evolution of the absorption profile of cyclosporine A in renal transplant recipients: a longitudinal study of the de novo and maintenance phases.

Auteurs : Matthias Büchler ; Steve Chadban ; Edward Cole ; Karsten Midtvedt ; Eric Thervet ; Hans Prestele ; Paul Keown

Source :

RBID : pubmed:16204301

English descriptors

Abstract

Therapeutic drug monitoring for cyclosporine microemulsion (CsA-ME) is often performed using either trough levels (C0) or levels at 2 h post-dose (C2). This analysis assessed changes in C0 and C2 and their relationship to CsA-ME dose over time post-transplant in renal transplant patients.

DOI: 10.1093/ndt/gfi113
PubMed: 16204301

Links to Exploration step

pubmed:16204301

Le document en format XML

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<title xml:lang="en">Evolution of the absorption profile of cyclosporine A in renal transplant recipients: a longitudinal study of the de novo and maintenance phases.</title>
<author>
<name sortKey="Buchler, Matthias" sort="Buchler, Matthias" uniqKey="Buchler M" first="Matthias" last="Büchler">Matthias Büchler</name>
<affiliation>
<nlm:affiliation>Department of Nephrology and Clinical Immunology, C.H.U. Tours, 2 Boulevard Tonnellé 37044 Tours, France, and Royal Prince Alfred Hospital, Sydney, Australia. buchler@med.univ-tours.fr</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Chadban, Steve" sort="Chadban, Steve" uniqKey="Chadban S" first="Steve" last="Chadban">Steve Chadban</name>
</author>
<author>
<name sortKey="Cole, Edward" sort="Cole, Edward" uniqKey="Cole E" first="Edward" last="Cole">Edward Cole</name>
</author>
<author>
<name sortKey="Midtvedt, Karsten" sort="Midtvedt, Karsten" uniqKey="Midtvedt K" first="Karsten" last="Midtvedt">Karsten Midtvedt</name>
</author>
<author>
<name sortKey="Thervet, Eric" sort="Thervet, Eric" uniqKey="Thervet E" first="Eric" last="Thervet">Eric Thervet</name>
</author>
<author>
<name sortKey="Prestele, Hans" sort="Prestele, Hans" uniqKey="Prestele H" first="Hans" last="Prestele">Hans Prestele</name>
</author>
<author>
<name sortKey="Keown, Paul" sort="Keown, Paul" uniqKey="Keown P" first="Paul" last="Keown">Paul Keown</name>
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<title xml:lang="en">Evolution of the absorption profile of cyclosporine A in renal transplant recipients: a longitudinal study of the de novo and maintenance phases.</title>
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<name sortKey="Buchler, Matthias" sort="Buchler, Matthias" uniqKey="Buchler M" first="Matthias" last="Büchler">Matthias Büchler</name>
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<nlm:affiliation>Department of Nephrology and Clinical Immunology, C.H.U. Tours, 2 Boulevard Tonnellé 37044 Tours, France, and Royal Prince Alfred Hospital, Sydney, Australia. buchler@med.univ-tours.fr</nlm:affiliation>
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<name sortKey="Chadban, Steve" sort="Chadban, Steve" uniqKey="Chadban S" first="Steve" last="Chadban">Steve Chadban</name>
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<name sortKey="Cole, Edward" sort="Cole, Edward" uniqKey="Cole E" first="Edward" last="Cole">Edward Cole</name>
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<author>
<name sortKey="Midtvedt, Karsten" sort="Midtvedt, Karsten" uniqKey="Midtvedt K" first="Karsten" last="Midtvedt">Karsten Midtvedt</name>
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<name sortKey="Thervet, Eric" sort="Thervet, Eric" uniqKey="Thervet E" first="Eric" last="Thervet">Eric Thervet</name>
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<name sortKey="Prestele, Hans" sort="Prestele, Hans" uniqKey="Prestele H" first="Hans" last="Prestele">Hans Prestele</name>
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<name sortKey="Keown, Paul" sort="Keown, Paul" uniqKey="Keown P" first="Paul" last="Keown">Paul Keown</name>
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<series>
<title level="j">Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association</title>
<idno type="ISSN">0931-0509</idno>
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<date when="2006" type="published">2006</date>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Aged</term>
<term>Cyclosporine (pharmacokinetics)</term>
<term>Cyclosporine (therapeutic use)</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Drug Monitoring (methods)</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Graft Rejection</term>
<term>Graft Survival (drug effects)</term>
<term>Humans</term>
<term>Immunosuppressive Agents (pharmacokinetics)</term>
<term>Immunosuppressive Agents (therapeutic use)</term>
<term>Kidney Failure, Chronic (diagnosis)</term>
<term>Kidney Failure, Chronic (immunology)</term>
<term>Kidney Failure, Chronic (surgery)</term>
<term>Kidney Transplantation (immunology)</term>
<term>Kidney Transplantation (methods)</term>
<term>Longitudinal Studies</term>
<term>Male</term>
<term>Maximum Tolerated Dose</term>
<term>Middle Aged</term>
<term>Probability</term>
<term>Prospective Studies</term>
<term>Risk Assessment</term>
<term>Sensitivity and Specificity</term>
<term>Time Factors</term>
<term>Transplantation Immunology</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en">
<term>Cyclosporine</term>
<term>Immunosuppressive Agents</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Cyclosporine</term>
<term>Immunosuppressive Agents</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en">
<term>Kidney Failure, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en">
<term>Graft Survival</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en">
<term>Kidney Failure, Chronic</term>
<term>Kidney Transplantation</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Drug Monitoring</term>
<term>Kidney Transplantation</term>
</keywords>
<keywords scheme="MESH" qualifier="surgery" xml:lang="en">
<term>Kidney Failure, Chronic</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Aged</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Graft Rejection</term>
<term>Humans</term>
<term>Longitudinal Studies</term>
<term>Male</term>
<term>Maximum Tolerated Dose</term>
<term>Middle Aged</term>
<term>Probability</term>
<term>Prospective Studies</term>
<term>Risk Assessment</term>
<term>Sensitivity and Specificity</term>
<term>Time Factors</term>
<term>Transplantation Immunology</term>
</keywords>
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<front>
<div type="abstract" xml:lang="en">Therapeutic drug monitoring for cyclosporine microemulsion (CsA-ME) is often performed using either trough levels (C0) or levels at 2 h post-dose (C2). This analysis assessed changes in C0 and C2 and their relationship to CsA-ME dose over time post-transplant in renal transplant patients.</div>
</front>
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<pubmed>
<MedlineCitation Status="MEDLINE" Owner="NLM">
<PMID Version="1">16204301</PMID>
<DateCreated>
<Year>2005</Year>
<Month>12</Month>
<Day>28</Day>
</DateCreated>
<DateCompleted>
<Year>2006</Year>
<Month>02</Month>
<Day>28</Day>
</DateCompleted>
<DateRevised>
<Year>2013</Year>
<Month>11</Month>
<Day>21</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Print">0931-0509</ISSN>
<JournalIssue CitedMedium="Print">
<Volume>21</Volume>
<Issue>1</Issue>
<PubDate>
<Year>2006</Year>
<Month>Jan</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>Evolution of the absorption profile of cyclosporine A in renal transplant recipients: a longitudinal study of the de novo and maintenance phases.</ArticleTitle>
<Pagination>
<MedlinePgn>197-202</MedlinePgn>
</Pagination>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Therapeutic drug monitoring for cyclosporine microemulsion (CsA-ME) is often performed using either trough levels (C0) or levels at 2 h post-dose (C2). This analysis assessed changes in C0 and C2 and their relationship to CsA-ME dose over time post-transplant in renal transplant patients.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Data were obtained from MO2ART, a prospective multicentre trial in which CsA-ME dose was adjusted based on C2 level. All 98 patients in whom C0 and C2 were available at day 5, month 3 and month 12 were included, out of 234 who completed the 12 month study. Normalized dose (ND) of CsA-ME, defined as dose per kilogram body weight, was calculated, together with C0/ND, C2/ND and C2/C0.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">C0/ND and C2/ND both increased between day 5 and month 3: C0/ND from 33+/-15 to 53+/-24 (ng/ml)/(mg/kg) and C2/ND from 161+/-64 to 248+/-80 (ng/ml)/(mg/kg). Between month 3 and month 12, C2/ND remained stable but C0/ND decreased to 42+/-20 (ng/ml)/(mg/kg) while the C2/C0 ratio increased from 5.2+/-1.9 to 6.5+/-2.3, indicating an acceleration of drug elimination. The inter-individual coefficient of variation was higher for C0/ND than for C2/ND at 3 months (45 vs 32%, P<0.05) and at 12 months (48 vs 31%, P<0.01).</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">CsA clearance accelerates between months 3 and 12 post-transplant, resulting in lower C0 levels for a given exposure (as measured by C2). As a consequence, C0 monitoring may progressively underestimate CsA exposure during the first year post-transplant. C2 monitoring contributes to improved individualized CsA-ME treatment in both the de novo phase and beyond month 3.</AbstractText>
</Abstract>
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<LastName>Büchler</LastName>
<ForeName>Matthias</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Department of Nephrology and Clinical Immunology, C.H.U. Tours, 2 Boulevard Tonnellé 37044 Tours, France, and Royal Prince Alfred Hospital, Sydney, Australia. buchler@med.univ-tours.fr</Affiliation>
</AffiliationInfo>
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<LastName>Chadban</LastName>
<ForeName>Steve</ForeName>
<Initials>S</Initials>
</Author>
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<LastName>Cole</LastName>
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<LastName>Midtvedt</LastName>
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<LastName>Thervet</LastName>
<ForeName>Eric</ForeName>
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<LastName>Prestele</LastName>
<ForeName>Hans</ForeName>
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<LastName>Keown</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
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<Language>eng</Language>
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<PublicationType UI="D003160">Comparative Study</PublicationType>
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<PublicationType UI="D016448">Multicenter Study</PublicationType>
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<Year>2005</Year>
<Month>10</Month>
<Day>04</Day>
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<Country>England</Country>
<MedlineTA>Nephrol Dial Transplant</MedlineTA>
<NlmUniqueID>8706402</NlmUniqueID>
<ISSNLinking>0931-0509</ISSNLinking>
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<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007166">Immunosuppressive Agents</NameOfSubstance>
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<Chemical>
<RegistryNumber>83HN0GTJ6D</RegistryNumber>
<NameOfSubstance UI="D016572">Cyclosporine</NameOfSubstance>
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<MeshHeading>
<DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D016572" MajorTopicYN="N">Cyclosporine</DescriptorName>
<QualifierName UI="Q000493" MajorTopicYN="Y">pharmacokinetics</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
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<DescriptorName UI="D006084" MajorTopicYN="N">Graft Rejection</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D007676" MajorTopicYN="N">Kidney Failure, Chronic</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000601" MajorTopicYN="Y">surgery</QualifierName>
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<MeshHeading>
<DescriptorName UI="D016030" MajorTopicYN="N">Kidney Transplantation</DescriptorName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D008137" MajorTopicYN="N">Longitudinal Studies</DescriptorName>
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<DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D020714" MajorTopicYN="N">Maximum Tolerated Dose</DescriptorName>
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