Evolution of the absorption profile of cyclosporine A in renal transplant recipients: a longitudinal study of the de novo and maintenance phases
Identifieur interne : 009996 ( Main/Exploration ); précédent : 009995; suivant : 009997Evolution of the absorption profile of cyclosporine A in renal transplant recipients: a longitudinal study of the de novo and maintenance phases
Auteurs : Matthias Bu Chler ; Steve Chadban ; Edward Cole ; Karsten Midtvedt ; Eric Thervet ; Hans Prestele [Suisse] ; Paul Keown [Canada]Source :
- Nephrology Dialysis Transplantation [ 0931-0509 ] ; 2006-01.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Calendrier d'administration des médicaments, Ciclosporine (pharmacocinétique), Ciclosporine (usage thérapeutique), Dose maximale tolérée, Défaillance rénale chronique (), Défaillance rénale chronique (diagnostic), Défaillance rénale chronique (immunologie), Facteurs temps, Femelle, Humains, Immunologie en transplantation, Immunosuppresseurs (pharmacocinétique), Immunosuppresseurs (usage thérapeutique), Mâle, Probabilité, Rejet du greffon, Relation dose-effet des médicaments, Sensibilité et spécificité, Sujet âgé, Surveillance pharmacologique (), Survie du greffon (), Transplantation rénale (), Transplantation rénale (immunologie), Études de suivi, Études longitudinales, Études prospectives, Évaluation des risques.
- MESH :
- diagnostic : Défaillance rénale chronique.
- immunologie : Défaillance rénale chronique, Transplantation rénale.
- pharmacocinétique : Ciclosporine, Immunosuppresseurs.
- usage thérapeutique : Ciclosporine, Immunosuppresseurs.
- Adulte d'âge moyen, Calendrier d'administration des médicaments, Dose maximale tolérée, Défaillance rénale chronique, Facteurs temps, Femelle, Humains, Immunologie en transplantation, Mâle, Probabilité, Rejet du greffon, Relation dose-effet des médicaments, Sensibilité et spécificité, Sujet âgé, Surveillance pharmacologique, Survie du greffon, Transplantation rénale, Études de suivi, Études longitudinales, Études prospectives, Évaluation des risques.
English descriptors
- KwdEn :
- Absorption profile, Acute rejection, Aged, Allograft recipients, Baseline characteristics, Blood concentration, Blood levels, Blood samples, C2 monitoring, Central laboratory, Clinical immunology, Cyclosporine, Cyclosporine (pharmacokinetics), Cyclosporine (therapeutic use), Cyclosporine microemulsion, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Monitoring (methods), Female, Follow-Up Studies, Graft Rejection, Graft Survival (drug effects), Humans, Immunosuppressive Agents (pharmacokinetics), Immunosuppressive Agents (therapeutic use), International neoral, Kidney Failure, Chronic (diagnosis), Kidney Failure, Chronic (immunology), Kidney Failure, Chronic (surgery), Kidney Transplantation (immunology), Kidney Transplantation (methods), Kidney transplantation, Kilogram body weight, Longitudinal Studies, Male, Maximum Tolerated Dose, Microemulsion, Middle Aged, Mo2art, Mo2art study, Mycophenolate mofetil, Neoral, Nephrol dial transplant, Pharmacokinetic, Pharmacokinetic parameters, Probability, Prospective Studies, Renal, Renal transplant patients, Renal transplant recipients, Renal transplantation, Risk Assessment, Sensitivity and Specificity, Steroid, Target group, Therapeutic drug monitoring, Time Factors, Transplant, Transplant patients, Transplant proc, Transplant recipients, Transplantation, Transplantation Immunology, Transplantation study group, Trough levels, Wilcoxon rank, absorption, cyclosporine microemulsion, renal transplantation.
- MESH :
- chemical , pharmacokinetics : Cyclosporine, Immunosuppressive Agents.
- chemical , therapeutic use : Cyclosporine, Immunosuppressive Agents.
- diagnosis : Kidney Failure, Chronic.
- drug effects : Graft Survival.
- immunology : Kidney Failure, Chronic, Kidney Transplantation.
- methods : Drug Monitoring, Kidney Transplantation.
- surgery : Kidney Failure, Chronic.
- Teeft :
- Absorption profile, Acute rejection, Aged, Allograft recipients, Baseline characteristics, Blood concentration, Blood levels, Blood samples, Central laboratory, Clinical immunology, Cyclosporine, Cyclosporine microemulsion, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Graft Rejection, Humans, International neoral, Kidney transplantation, Kilogram body weight, Longitudinal Studies, Male, Maximum Tolerated Dose, Microemulsion, Middle Aged, Mo2art, Mo2art study, Mycophenolate mofetil, Neoral, Nephrol dial transplant, Pharmacokinetic, Pharmacokinetic parameters, Probability, Prospective Studies, Renal, Renal transplant patients, Renal transplant recipients, Renal transplantation, Risk Assessment, Sensitivity and Specificity, Steroid, Target group, Therapeutic drug monitoring, Time Factors, Transplant, Transplant patients, Transplant proc, Transplant recipients, Transplantation, Transplantation Immunology, Transplantation study group, Trough levels, Wilcoxon rank.
Abstract
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. 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. 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). 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.
Url:
DOI: 10.1093/ndt/gfi113
Affiliations:
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Absorption profile</term>
<term>Acute rejection</term>
<term>Aged</term>
<term>Allograft recipients</term>
<term>Baseline characteristics</term>
<term>Blood concentration</term>
<term>Blood levels</term>
<term>Blood samples</term>
<term>C2 monitoring</term>
<term>Central laboratory</term>
<term>Clinical immunology</term>
<term>Cyclosporine</term>
<term>Cyclosporine (pharmacokinetics)</term>
<term>Cyclosporine (therapeutic use)</term>
<term>Cyclosporine microemulsion</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>International neoral</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>Kidney transplantation</term>
<term>Kilogram body weight</term>
<term>Longitudinal Studies</term>
<term>Male</term>
<term>Maximum Tolerated Dose</term>
<term>Microemulsion</term>
<term>Middle Aged</term>
<term>Mo2art</term>
<term>Mo2art study</term>
<term>Mycophenolate mofetil</term>
<term>Neoral</term>
<term>Nephrol dial transplant</term>
<term>Pharmacokinetic</term>
<term>Pharmacokinetic parameters</term>
<term>Probability</term>
<term>Prospective Studies</term>
<term>Renal</term>
<term>Renal transplant patients</term>
<term>Renal transplant recipients</term>
<term>Renal transplantation</term>
<term>Risk Assessment</term>
<term>Sensitivity and Specificity</term>
<term>Steroid</term>
<term>Target group</term>
<term>Therapeutic drug monitoring</term>
<term>Time Factors</term>
<term>Transplant</term>
<term>Transplant patients</term>
<term>Transplant proc</term>
<term>Transplant recipients</term>
<term>Transplantation</term>
<term>Transplantation Immunology</term>
<term>Transplantation study group</term>
<term>Trough levels</term>
<term>Wilcoxon rank</term>
<term>absorption</term>
<term>cyclosporine microemulsion</term>
<term>renal transplantation</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Calendrier d'administration des médicaments</term>
<term>Ciclosporine (pharmacocinétique)</term>
<term>Ciclosporine (usage thérapeutique)</term>
<term>Dose maximale tolérée</term>
<term>Défaillance rénale chronique ()</term>
<term>Défaillance rénale chronique (diagnostic)</term>
<term>Défaillance rénale chronique (immunologie)</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Immunologie en transplantation</term>
<term>Immunosuppresseurs (pharmacocinétique)</term>
<term>Immunosuppresseurs (usage thérapeutique)</term>
<term>Mâle</term>
<term>Probabilité</term>
<term>Rejet du greffon</term>
<term>Relation dose-effet des médicaments</term>
<term>Sensibilité et spécificité</term>
<term>Sujet âgé</term>
<term>Surveillance pharmacologique ()</term>
<term>Survie du greffon ()</term>
<term>Transplantation rénale ()</term>
<term>Transplantation rénale (immunologie)</term>
<term>Études de suivi</term>
<term>Études longitudinales</term>
<term>Études prospectives</term>
<term>Évaluation des risques</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="diagnostic" xml:lang="fr"><term>Défaillance rénale chronique</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Graft Survival</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Défaillance rénale chronique</term>
<term>Transplantation rénale</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="pharmacocinétique" xml:lang="fr"><term>Ciclosporine</term>
<term>Immunosuppresseurs</term>
</keywords>
<keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Kidney Failure, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Ciclosporine</term>
<term>Immunosuppresseurs</term>
</keywords>
<keywords scheme="Teeft" xml:lang="en"><term>Absorption profile</term>
<term>Acute rejection</term>
<term>Aged</term>
<term>Allograft recipients</term>
<term>Baseline characteristics</term>
<term>Blood concentration</term>
<term>Blood levels</term>
<term>Blood samples</term>
<term>Central laboratory</term>
<term>Clinical immunology</term>
<term>Cyclosporine</term>
<term>Cyclosporine microemulsion</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>International neoral</term>
<term>Kidney transplantation</term>
<term>Kilogram body weight</term>
<term>Longitudinal Studies</term>
<term>Male</term>
<term>Maximum Tolerated Dose</term>
<term>Microemulsion</term>
<term>Middle Aged</term>
<term>Mo2art</term>
<term>Mo2art study</term>
<term>Mycophenolate mofetil</term>
<term>Neoral</term>
<term>Nephrol dial transplant</term>
<term>Pharmacokinetic</term>
<term>Pharmacokinetic parameters</term>
<term>Probability</term>
<term>Prospective Studies</term>
<term>Renal</term>
<term>Renal transplant patients</term>
<term>Renal transplant recipients</term>
<term>Renal transplantation</term>
<term>Risk Assessment</term>
<term>Sensitivity and Specificity</term>
<term>Steroid</term>
<term>Target group</term>
<term>Therapeutic drug monitoring</term>
<term>Time Factors</term>
<term>Transplant</term>
<term>Transplant patients</term>
<term>Transplant proc</term>
<term>Transplant recipients</term>
<term>Transplantation</term>
<term>Transplantation Immunology</term>
<term>Transplantation study group</term>
<term>Trough levels</term>
<term>Wilcoxon rank</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Calendrier d'administration des médicaments</term>
<term>Dose maximale tolérée</term>
<term>Défaillance rénale chronique</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Immunologie en transplantation</term>
<term>Mâle</term>
<term>Probabilité</term>
<term>Rejet du greffon</term>
<term>Relation dose-effet des médicaments</term>
<term>Sensibilité et spécificité</term>
<term>Sujet âgé</term>
<term>Surveillance pharmacologique</term>
<term>Survie du greffon</term>
<term>Transplantation rénale</term>
<term>Études de suivi</term>
<term>Études longitudinales</term>
<term>Études prospectives</term>
<term>Évaluation des risques</term>
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<front><div type="abstract" xml:lang="en">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. 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. 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). 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.</div>
</front>
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