Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice
Summary Background We recently developed and validated limited sampling models (LSMs) for cyclosporine monitoring after orthotopic liver transplantation based on individualized population pharmacokinetic models with Bayesian modelling. Aim To evaluate LSM in practice, and to seek optimal balance b...
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| Veröffentlicht in: | Alimentary pharmacology & therapeutics 2007-11, Vol.26 (10), p.1447-1454 |
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| creator | LANGERS, P. CREMERS, S. C. L. M. DEN HARTIGH, J. RIJNBEEK, E. M. T. RINGERS, J. LAMERS, C. B. H. W. HOMMES, D. W. VAN HOEK, B. |
| description | Summary
Background We recently developed and validated limited sampling models (LSMs) for cyclosporine monitoring after orthotopic liver transplantation based on individualized population pharmacokinetic models with Bayesian modelling.
Aim To evaluate LSM in practice, and to seek optimal balance between benefit and discomfort.
Methods In 30 stable patients, more than 6 months after orthotopic liver transplantation, previously switched from trough‐ to 2 h post‐dose (C2)‐monitoring, we switched to 3‐monthly LSM 0,1,2,3 h‐monitoring. During 18 months we evaluated dose, creatinine clearance, calculated area under the curve, intra‐patient pharmacokinetic variability and ability to assess systemic exposure by several previously validated LSMs.
Results Within patients, there was variability of cyclosporine‐area under the curve with the same dose (CV of 15%). Compared to C2‐monitoring, there was no significant difference in dose (P = 0.237), creatinine clearance (P = 0.071) and number of rejections. Some models showed excellent correlation and precision with LSM 0,1,2,3 h comparing area under the curves (0,2 h: r2 = 0.88; 0,1,3 h: r2 = 0.91; 0,2,3 h: r2 = 0.92, all P |
| doi_str_mv | 10.1111/j.1365-2036.2007.03514.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_68471751</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>68471751</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4474-61e735dff1fd6c3c067d38f3be16382386870856dcb2f18df332dbbf75c59c673</originalsourceid><addsrcrecordid>eNqNkctu1DAUhi0EotPCKyBvYJfgS2J7FiyqqkClSrAoa8vxpfXgxMF22g6PwRPjdEZ0ixf2kfyd2_8DADFqcT0fdy2mrG8IoqwlCPEW0R537eMLsPn38RJsEGHbhghMT8BpzjuEEOOIvAYnmItOYEE24M_VZPy9N4sK_rc1cI7zElTxcYLznUqj0vGnn2zxGo7R2AAffLmDwY--VDqrcQ5-uoUuJqj3OsQ8x1T5Ck--rOEtVK7YVFPu612SmvIc1FQOPfwEdS3gtQpwTkrXPvYNeOVUyPbt8T0DPz5f3lx8ba6_fbm6OL9udNfxrmHYctob57AzTFNddzNUODpYzKggVDDBkeiZ0QNxWBhHKTHD4Hiv-61mnJ6BD4e6c4q_FpuLHH3WNtTpbFyyZKLjmPe4guIA6hRzTtbJOflRpb3ESK5-yJ1cZZer7HL1Qz75IR9r6rtjj2UYrXlOPBpQgfdHQOUqgqv6aJ-fuW3PEKeicp8O3IMPdv_fA8jz7zdrRP8CBNqrBg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>68471751</pqid></control><display><type>article</type><title>Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice</title><source>Wiley Free Content</source><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>LANGERS, P. ; CREMERS, S. C. L. M. ; DEN HARTIGH, J. ; RIJNBEEK, E. M. T. ; RINGERS, J. ; LAMERS, C. B. H. W. ; HOMMES, D. W. ; VAN HOEK, B.</creator><creatorcontrib>LANGERS, P. ; CREMERS, S. C. L. M. ; DEN HARTIGH, J. ; RIJNBEEK, E. M. T. ; RINGERS, J. ; LAMERS, C. B. H. W. ; HOMMES, D. W. ; VAN HOEK, B.</creatorcontrib><description>Summary
Background We recently developed and validated limited sampling models (LSMs) for cyclosporine monitoring after orthotopic liver transplantation based on individualized population pharmacokinetic models with Bayesian modelling.
Aim To evaluate LSM in practice, and to seek optimal balance between benefit and discomfort.
Methods In 30 stable patients, more than 6 months after orthotopic liver transplantation, previously switched from trough‐ to 2 h post‐dose (C2)‐monitoring, we switched to 3‐monthly LSM 0,1,2,3 h‐monitoring. During 18 months we evaluated dose, creatinine clearance, calculated area under the curve, intra‐patient pharmacokinetic variability and ability to assess systemic exposure by several previously validated LSMs.
Results Within patients, there was variability of cyclosporine‐area under the curve with the same dose (CV of 15%). Compared to C2‐monitoring, there was no significant difference in dose (P = 0.237), creatinine clearance (P = 0.071) and number of rejections. Some models showed excellent correlation and precision with LSM 0,1,2,3 h comparing area under the curves (0,2 h: r2 = 0.88; 0,1,3 h: r2 = 0.91; 0,2,3 h: r2 = 0.92, all P < 0.001) with no difference in advised dose.
Conclusions The limited sampling model, with only trough‐ and 2‐h sampling, yields excellent accuracy and assesses systemic exposure much better than C2 with less bias and greater precision. Considering the calculated intra‐patient variability, more precision is redundant, so LSM 0,2 h seems the optimal way of cyclosporine‐monitoring.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/j.1365-2036.2007.03514.x</identifier><identifier>PMID: 17848182</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Area Under Curve ; Bayes Theorem ; Biological and medical sciences ; Cyclosporine - administration & dosage ; Cyclosporine - pharmacokinetics ; Digestive system ; Dose-Response Relationship, Drug ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Graft Rejection - prevention & control ; Humans ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - pharmacokinetics ; Liver Transplantation - rehabilitation ; Male ; Medical sciences ; Middle Aged ; Models, Chemical ; Pharmacology. Drug treatments ; Regression Analysis ; Sensitivity and Specificity</subject><ispartof>Alimentary pharmacology & therapeutics, 2007-11, Vol.26 (10), p.1447-1454</ispartof><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4474-61e735dff1fd6c3c067d38f3be16382386870856dcb2f18df332dbbf75c59c673</citedby><cites>FETCH-LOGICAL-c4474-61e735dff1fd6c3c067d38f3be16382386870856dcb2f18df332dbbf75c59c673</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2036.2007.03514.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2036.2007.03514.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=19560738$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17848182$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>LANGERS, P.</creatorcontrib><creatorcontrib>CREMERS, S. C. L. M.</creatorcontrib><creatorcontrib>DEN HARTIGH, J.</creatorcontrib><creatorcontrib>RIJNBEEK, E. M. T.</creatorcontrib><creatorcontrib>RINGERS, J.</creatorcontrib><creatorcontrib>LAMERS, C. B. H. W.</creatorcontrib><creatorcontrib>HOMMES, D. W.</creatorcontrib><creatorcontrib>VAN HOEK, B.</creatorcontrib><title>Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Summary
Background We recently developed and validated limited sampling models (LSMs) for cyclosporine monitoring after orthotopic liver transplantation based on individualized population pharmacokinetic models with Bayesian modelling.
Aim To evaluate LSM in practice, and to seek optimal balance between benefit and discomfort.
Methods In 30 stable patients, more than 6 months after orthotopic liver transplantation, previously switched from trough‐ to 2 h post‐dose (C2)‐monitoring, we switched to 3‐monthly LSM 0,1,2,3 h‐monitoring. During 18 months we evaluated dose, creatinine clearance, calculated area under the curve, intra‐patient pharmacokinetic variability and ability to assess systemic exposure by several previously validated LSMs.
Results Within patients, there was variability of cyclosporine‐area under the curve with the same dose (CV of 15%). Compared to C2‐monitoring, there was no significant difference in dose (P = 0.237), creatinine clearance (P = 0.071) and number of rejections. Some models showed excellent correlation and precision with LSM 0,1,2,3 h comparing area under the curves (0,2 h: r2 = 0.88; 0,1,3 h: r2 = 0.91; 0,2,3 h: r2 = 0.92, all P < 0.001) with no difference in advised dose.
Conclusions The limited sampling model, with only trough‐ and 2‐h sampling, yields excellent accuracy and assesses systemic exposure much better than C2 with less bias and greater precision. Considering the calculated intra‐patient variability, more precision is redundant, so LSM 0,2 h seems the optimal way of cyclosporine‐monitoring.</description><subject>Adult</subject><subject>Aged</subject><subject>Area Under Curve</subject><subject>Bayes Theorem</subject><subject>Biological and medical sciences</subject><subject>Cyclosporine - administration & dosage</subject><subject>Cyclosporine - pharmacokinetics</subject><subject>Digestive system</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Graft Rejection - prevention & control</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - pharmacokinetics</subject><subject>Liver Transplantation - rehabilitation</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Models, Chemical</subject><subject>Pharmacology. Drug treatments</subject><subject>Regression Analysis</subject><subject>Sensitivity and Specificity</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkctu1DAUhi0EotPCKyBvYJfgS2J7FiyqqkClSrAoa8vxpfXgxMF22g6PwRPjdEZ0ixf2kfyd2_8DADFqcT0fdy2mrG8IoqwlCPEW0R537eMLsPn38RJsEGHbhghMT8BpzjuEEOOIvAYnmItOYEE24M_VZPy9N4sK_rc1cI7zElTxcYLznUqj0vGnn2zxGo7R2AAffLmDwY--VDqrcQ5-uoUuJqj3OsQ8x1T5Ck--rOEtVK7YVFPu612SmvIc1FQOPfwEdS3gtQpwTkrXPvYNeOVUyPbt8T0DPz5f3lx8ba6_fbm6OL9udNfxrmHYctob57AzTFNddzNUODpYzKggVDDBkeiZ0QNxWBhHKTHD4Hiv-61mnJ6BD4e6c4q_FpuLHH3WNtTpbFyyZKLjmPe4guIA6hRzTtbJOflRpb3ESK5-yJ1cZZer7HL1Qz75IR9r6rtjj2UYrXlOPBpQgfdHQOUqgqv6aJ-fuW3PEKeicp8O3IMPdv_fA8jz7zdrRP8CBNqrBg</recordid><startdate>20071115</startdate><enddate>20071115</enddate><creator>LANGERS, P.</creator><creator>CREMERS, S. C. L. M.</creator><creator>DEN HARTIGH, J.</creator><creator>RIJNBEEK, E. M. T.</creator><creator>RINGERS, J.</creator><creator>LAMERS, C. B. H. W.</creator><creator>HOMMES, D. W.</creator><creator>VAN HOEK, B.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20071115</creationdate><title>Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice</title><author>LANGERS, P. ; CREMERS, S. C. L. M. ; DEN HARTIGH, J. ; RIJNBEEK, E. M. T. ; RINGERS, J. ; LAMERS, C. B. H. W. ; HOMMES, D. W. ; VAN HOEK, B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4474-61e735dff1fd6c3c067d38f3be16382386870856dcb2f18df332dbbf75c59c673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Area Under Curve</topic><topic>Bayes Theorem</topic><topic>Biological and medical sciences</topic><topic>Cyclosporine - administration & dosage</topic><topic>Cyclosporine - pharmacokinetics</topic><topic>Digestive system</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Graft Rejection - prevention & control</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - pharmacokinetics</topic><topic>Liver Transplantation - rehabilitation</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Models, Chemical</topic><topic>Pharmacology. Drug treatments</topic><topic>Regression Analysis</topic><topic>Sensitivity and Specificity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>LANGERS, P.</creatorcontrib><creatorcontrib>CREMERS, S. C. L. M.</creatorcontrib><creatorcontrib>DEN HARTIGH, J.</creatorcontrib><creatorcontrib>RIJNBEEK, E. M. T.</creatorcontrib><creatorcontrib>RINGERS, J.</creatorcontrib><creatorcontrib>LAMERS, C. B. H. W.</creatorcontrib><creatorcontrib>HOMMES, D. W.</creatorcontrib><creatorcontrib>VAN HOEK, B.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>LANGERS, P.</au><au>CREMERS, S. C. L. M.</au><au>DEN HARTIGH, J.</au><au>RIJNBEEK, E. M. T.</au><au>RINGERS, J.</au><au>LAMERS, C. B. H. W.</au><au>HOMMES, D. W.</au><au>VAN HOEK, B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>2007-11-15</date><risdate>2007</risdate><volume>26</volume><issue>10</issue><spage>1447</spage><epage>1454</epage><pages>1447-1454</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary
Background We recently developed and validated limited sampling models (LSMs) for cyclosporine monitoring after orthotopic liver transplantation based on individualized population pharmacokinetic models with Bayesian modelling.
Aim To evaluate LSM in practice, and to seek optimal balance between benefit and discomfort.
Methods In 30 stable patients, more than 6 months after orthotopic liver transplantation, previously switched from trough‐ to 2 h post‐dose (C2)‐monitoring, we switched to 3‐monthly LSM 0,1,2,3 h‐monitoring. During 18 months we evaluated dose, creatinine clearance, calculated area under the curve, intra‐patient pharmacokinetic variability and ability to assess systemic exposure by several previously validated LSMs.
Results Within patients, there was variability of cyclosporine‐area under the curve with the same dose (CV of 15%). Compared to C2‐monitoring, there was no significant difference in dose (P = 0.237), creatinine clearance (P = 0.071) and number of rejections. Some models showed excellent correlation and precision with LSM 0,1,2,3 h comparing area under the curves (0,2 h: r2 = 0.88; 0,1,3 h: r2 = 0.91; 0,2,3 h: r2 = 0.92, all P < 0.001) with no difference in advised dose.
Conclusions The limited sampling model, with only trough‐ and 2‐h sampling, yields excellent accuracy and assesses systemic exposure much better than C2 with less bias and greater precision. Considering the calculated intra‐patient variability, more precision is redundant, so LSM 0,2 h seems the optimal way of cyclosporine‐monitoring.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>17848182</pmid><doi>10.1111/j.1365-2036.2007.03514.x</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Area Under Curve Bayes Theorem Biological and medical sciences Cyclosporine - administration & dosage Cyclosporine - pharmacokinetics Digestive system Dose-Response Relationship, Drug Female Gastroenterology. Liver. Pancreas. Abdomen Graft Rejection - prevention & control Humans Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - pharmacokinetics Liver Transplantation - rehabilitation Male Medical sciences Middle Aged Models, Chemical Pharmacology. Drug treatments Regression Analysis Sensitivity and Specificity |
| title | Individualized population pharmacokinetic model with limited sampling for cyclosporine monitoring after liver transplantation in clinical practice |
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