Limited sampling strategy for cyclosporine (Neoral®) area under the curve monitoring in pediatric kidney transplant recipients
: Cyclosporine (CSA; Neoral®) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant recipients has shown that 2‐h post‐dose concentration (C2) monitoring and limited sampling strategies (LSSs) are better at predicting drug exposure...
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Published in | Pediatric transplantation Vol. 9; no. 5; pp. 566 - 573 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Munksgaard International Publishers
01.10.2005
Blackwell |
Subjects | |
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Abstract | : Cyclosporine (CSA; Neoral®) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant recipients has shown that 2‐h post‐dose concentration (C2) monitoring and limited sampling strategies (LSSs) are better at predicting drug exposure and outcome than trough concentrations (C0). While C0 monitoring is the usual practice in pediatric renal transplant patients, area under the curve (AUC) monitoring has been shown to be superior in terms of predictive ability and outcomes. However, AUC monitoring is impractical and inconvenient in a clinic setting because it involves many blood samples. An LSS provides a reliable alternative. The purpose of this study was to prospectively define an LSS (AUC0−12) for CSA monitoring and to test its predictive performance. As well, an LSS (AUC0−4) for CSA was developed and its predictive performance tested. Blood samples for CSA concentrations were collected in 29 stable pediatric renal transplant patients prior to (t = 0) and at 0.5, 1, 2, 4, 6, and 8 h following a steady‐state morning CSA dose. AUC was calculated by the trapezoidal method; LSSs for AUC0−12 and AUC0−4 were determined using multiple regression analysis in 14 patients; and the LSSs’ predictive performance was tested in 15 additional patients. Both LSSs require two blood samples. For the LSS (AUC0−12), blood samples are required immediately before the dose and 2 h post‐dose: AUC0−12 = 12.45 C0 + 2.17 C2 + 723.16 (r2 = 0.909). For the LSS (AUC0−4), blood samples are required at one and 2 h post‐dose, AUC0−4 = 1.17 C1 + 1.85 C2 − 41.00 (r2 = 0.971). The LSSs demonstrated low bias and high precision for both AUC0−12 and AUC0−4. Our two‐concentration LSSs are accurate and precise predictors that are more clinically useful for our patient population than other LSSs that have been developed for pediatric renal transplant patients. Our study template provides a guide for other centers to develop accurate and precise LSSs specific to their own patient population. |
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AbstractList | Cyclosporine (CSA; Neoral) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant recipients has shown that 2-h post-dose concentration (C2) monitoring and limited sampling strategies (LSSs) are better at predicting drug exposure and outcome than trough concentrations (C0). While C0 monitoring is the usual practice in pediatric renal transplant patients, area under the curve (AUC) monitoring has been shown to be superior in terms of predictive ability and outcomes. However, AUC monitoring is impractical and inconvenient in a clinic setting because it involves many blood samples. An LSS provides a reliable alternative. The purpose of this study was to prospectively define an LSS (AUC(0-12)) for CSA monitoring and to test its predictive performance. As well, an LSS (AUC(0-4)) for CSA was developed and its predictive performance tested. Blood samples for CSA concentrations were collected in 29 stable pediatric renal transplant patients prior to (t = 0) and at 0.5, 1, 2, 4, 6, and 8 h following a steady-state morning CSA dose. AUC was calculated by the trapezoidal method; LSSs for AUC(0-12) and AUC(0-4) were determined using multiple regression analysis in 14 patients; and the LSSs' predictive performance was tested in 15 additional patients. Both LSSs require two blood samples. For the LSS (AUC(0-12)), blood samples are required immediately before the dose and 2 h post-dose: AUC(0-12) = 12.45 C0 + 2.17 C2 + 723.16 (r2 = 0.909). For the LSS (AUC(0-4)), blood samples are required at one and 2 h post-dose, AUC(0-4) = 1.17 C1 + 1.85 C2 - 41.00 (r2 = 0.971). The LSSs demonstrated low bias and high precision for both AUC(0-12) and AUC(0-4). Our two-concentration LSSs are accurate and precise predictors that are more clinically useful for our patient population than other LSSs that have been developed for pediatric renal transplant patients. Our study template provides a guide for other centers to develop accurate and precise LSSs specific to their own patient population. : Cyclosporine (CSA; Neoral®) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant recipients has shown that 2‐h post‐dose concentration (C2) monitoring and limited sampling strategies (LSSs) are better at predicting drug exposure and outcome than trough concentrations (C0). While C0 monitoring is the usual practice in pediatric renal transplant patients, area under the curve (AUC) monitoring has been shown to be superior in terms of predictive ability and outcomes. However, AUC monitoring is impractical and inconvenient in a clinic setting because it involves many blood samples. An LSS provides a reliable alternative. The purpose of this study was to prospectively define an LSS (AUC0−12) for CSA monitoring and to test its predictive performance. As well, an LSS (AUC0−4) for CSA was developed and its predictive performance tested. Blood samples for CSA concentrations were collected in 29 stable pediatric renal transplant patients prior to (t = 0) and at 0.5, 1, 2, 4, 6, and 8 h following a steady‐state morning CSA dose. AUC was calculated by the trapezoidal method; LSSs for AUC0−12 and AUC0−4 were determined using multiple regression analysis in 14 patients; and the LSSs’ predictive performance was tested in 15 additional patients. Both LSSs require two blood samples. For the LSS (AUC0−12), blood samples are required immediately before the dose and 2 h post‐dose: AUC0−12 = 12.45 C0 + 2.17 C2 + 723.16 (r2 = 0.909). For the LSS (AUC0−4), blood samples are required at one and 2 h post‐dose, AUC0−4 = 1.17 C1 + 1.85 C2 − 41.00 (r2 = 0.971). The LSSs demonstrated low bias and high precision for both AUC0−12 and AUC0−4. Our two‐concentration LSSs are accurate and precise predictors that are more clinically useful for our patient population than other LSSs that have been developed for pediatric renal transplant patients. Our study template provides a guide for other centers to develop accurate and precise LSSs specific to their own patient population. Cyclosporine (CSA; Neoral ® ) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant recipients has shown that 2‐h post‐dose concentration ( C 2 ) monitoring and limited sampling strategies (LSSs) are better at predicting drug exposure and outcome than trough concentrations ( C 0 ). While C 0 monitoring is the usual practice in pediatric renal transplant patients, area under the curve (AUC) monitoring has been shown to be superior in terms of predictive ability and outcomes. However, AUC monitoring is impractical and inconvenient in a clinic setting because it involves many blood samples. An LSS provides a reliable alternative. The purpose of this study was to prospectively define an LSS (AUC 0−12 ) for CSA monitoring and to test its predictive performance. As well, an LSS (AUC 0−4 ) for CSA was developed and its predictive performance tested. Blood samples for CSA concentrations were collected in 29 stable pediatric renal transplant patients prior to ( t = 0) and at 0.5, 1, 2, 4, 6, and 8 h following a steady‐state morning CSA dose. AUC was calculated by the trapezoidal method; LSSs for AUC 0−12 and AUC 0−4 were determined using multiple regression analysis in 14 patients; and the LSSs’ predictive performance was tested in 15 additional patients. Both LSSs require two blood samples. For the LSS (AUC 0−12 ), blood samples are required immediately before the dose and 2 h post‐dose: AUC 0−12 = 12.45 C 0 + 2.17 C 2 + 723.16 (r 2 = 0.909). For the LSS (AUC 0−4 ), blood samples are required at one and 2 h post‐dose, AUC 0−4 = 1.17 C 1 + 1.85 C 2 − 41.00 (r 2 = 0.971). The LSSs demonstrated low bias and high precision for both AUC 0−12 and AUC 0−4 . Our two‐concentration LSSs are accurate and precise predictors that are more clinically useful for our patient population than other LSSs that have been developed for pediatric renal transplant patients. Our study template provides a guide for other centers to develop accurate and precise LSSs specific to their own patient population. |
Author | Lai, Amanda Lirenman, David S. Morrison Hurley, R. Carter, James E. Ensom, Mary H.H. White, Colin T. Primmett, Dennis Strong, Dawn K. Virji, Mumtaz |
Author_xml | – sequence: 1 givenname: Dawn K. surname: Strong fullname: Strong, Dawn K. organization: The British Columbia Transplant Society, Vancouver, British Columbia, Canada – sequence: 2 givenname: Amanda surname: Lai fullname: Lai, Amanda organization: Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, British Columbia, Canada – sequence: 3 givenname: Dennis surname: Primmett fullname: Primmett, Dennis organization: Department of Pharmacy, Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia, Canada – sequence: 4 givenname: Colin T. surname: White fullname: White, Colin T. organization: Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada – sequence: 5 givenname: David S. surname: Lirenman fullname: Lirenman, David S. organization: Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada – sequence: 6 givenname: James E. surname: Carter fullname: Carter, James E. organization: Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada – sequence: 7 givenname: R. surname: Morrison Hurley fullname: Morrison Hurley, R. organization: Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada – sequence: 8 givenname: Mumtaz surname: Virji fullname: Virji, Mumtaz organization: Department of Pediatrics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada – sequence: 9 givenname: Mary H.H. surname: Ensom fullname: Ensom, Mary H.H. organization: Department of Pharmacy, Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia, Canada |
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Keywords | Human cyclosporine Pediatrics Calcineurin inhibitor renal transplantation Homotransplantation Kidney limited sampling strategy pediatric Treatment Urinary system Surveillance Surgery Area under the curve Graft Strategy Ciclosporin Immunosuppressive agent Pharmacokinetics Limited sampling Child Monitoring Kidney transplantation |
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Snippet | : Cyclosporine (CSA; Neoral®) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant... Cyclosporine (CSA; Neoral) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant recipients... Cyclosporine (CSA; Neoral ® ) is one of the most common immunosuppressants used in pediatric renal transplantation. Research in adult renal transplant... |
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SubjectTerms | Adolescent Area Under Curve Biological and medical sciences Blood Specimen Collection Child cyclosporine Cyclosporine - pharmacokinetics Drug Monitoring - methods Female Humans Immunosuppressive Agents - pharmacokinetics Kidney Transplantation limited sampling strategy Male Medical sciences pediatric pharmacokinetics renal transplantation Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the urinary system |
Title | Limited sampling strategy for cyclosporine (Neoral®) area under the curve monitoring in pediatric kidney transplant recipients |
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