Dose increase needed in most cystic fibrosis lung transplantation patients when changing from twice- to once-daily tacrolimus oral administration
Aim The aim of this pharmacokinetic (PK) study was to evaluate tacrolimus (TAC) exposure in stable cystic fibrosis (CF) lung transplant (LT) recipients, converted from TAC twice daily to TAC once daily in an open-label, prospective, single-centre study. Methods Eligible patients were post-transplant...
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Veröffentlicht in: | European journal of clinical pharmacology 2015-06, Vol.71 (6), p.715-722 |
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creator | Soto, Gustavo Adolfo Centeno Ruiz-Antorán, Belén Laporta, Rosalía Sancho, Arantxa Lázaro, María Teresa Herrera, Concepción Payares Salcedo, Isabel Cos, Maria Angeles Torres, Ferrán Usetti, Piedad Avendaño-Sola, Cristina |
description | Aim
The aim of this pharmacokinetic (PK) study was to evaluate tacrolimus (TAC) exposure in stable cystic fibrosis (CF) lung transplant (LT) recipients, converted from TAC twice daily to TAC once daily in an open-label, prospective, single-centre study.
Methods
Eligible patients were post-transplant CF patients (18–65 years) with stable lung function, on stable doses of TAC twice daily and who were candidates to switch to TAC once daily. Twelve consecutive patients were included in the study. Patients had their first PK analysis on day 1, still under the stable TAC twice-daily regimen, and were converted to TAC once daily from day 2 onwards. The doses were adjusted according to clinical judgement to achieve target levels, and a second 24-h PK period profile was obtained once the patient was on a stable dosage on the therapeutic range.
Results
The mean total (SD) daily dose of TAC twice daily at baseline upon enrolment was 0.17 (0.10) mg/kg/day. The mean (SD) daily dose of TAC once daily after adjustments was 0.22 (0.12) mg/kg/day. In order to achieve target
C
min
levels with a similar AUC
0–24
, 82 % of subjects who were converted to TAC once daily required an increase of dose, in a range of 0–66.7 %, with a mean dose increase of 28 %.
Conclusions
Our study results indicate that the switch for conversion from TAC twice daily to TAC once daily in patients with CF may need dose adjustment in order to reach levels within the therapeutic target. |
doi_str_mv | 10.1007/s00228-015-1859-2 |
format | Article |
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The aim of this pharmacokinetic (PK) study was to evaluate tacrolimus (TAC) exposure in stable cystic fibrosis (CF) lung transplant (LT) recipients, converted from TAC twice daily to TAC once daily in an open-label, prospective, single-centre study.
Methods
Eligible patients were post-transplant CF patients (18–65 years) with stable lung function, on stable doses of TAC twice daily and who were candidates to switch to TAC once daily. Twelve consecutive patients were included in the study. Patients had their first PK analysis on day 1, still under the stable TAC twice-daily regimen, and were converted to TAC once daily from day 2 onwards. The doses were adjusted according to clinical judgement to achieve target levels, and a second 24-h PK period profile was obtained once the patient was on a stable dosage on the therapeutic range.
Results
The mean total (SD) daily dose of TAC twice daily at baseline upon enrolment was 0.17 (0.10) mg/kg/day. The mean (SD) daily dose of TAC once daily after adjustments was 0.22 (0.12) mg/kg/day. In order to achieve target
C
min
levels with a similar AUC
0–24
, 82 % of subjects who were converted to TAC once daily required an increase of dose, in a range of 0–66.7 %, with a mean dose increase of 28 %.
Conclusions
Our study results indicate that the switch for conversion from TAC twice daily to TAC once daily in patients with CF may need dose adjustment in order to reach levels within the therapeutic target.</description><identifier>ISSN: 0031-6970</identifier><identifier>EISSN: 1432-1041</identifier><identifier>DOI: 10.1007/s00228-015-1859-2</identifier><identifier>PMID: 25953736</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Administration, Oral ; Adult ; Area Under Curve ; Biomedical and Life Sciences ; Biomedicine ; Cystic fibrosis ; Cystic Fibrosis - metabolism ; Cystic Fibrosis - physiopathology ; Drug Administration Schedule ; Drug therapy ; Female ; Humans ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - pharmacokinetics ; Lung Transplantation - methods ; Lungs ; Male ; Pharmacokinetics and Disposition ; Pharmacology ; Pharmacology/Toxicology ; Tacrolimus - administration & dosage ; Tacrolimus - pharmacokinetics ; Transplants & implants ; Young Adult</subject><ispartof>European journal of clinical pharmacology, 2015-06, Vol.71 (6), p.715-722</ispartof><rights>Springer-Verlag Berlin Heidelberg 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-c8a4087e91d90a60b768dc1066f7b090b656f8c77dcfba2ce1df30ae7319e6f3</citedby><cites>FETCH-LOGICAL-c372t-c8a4087e91d90a60b768dc1066f7b090b656f8c77dcfba2ce1df30ae7319e6f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00228-015-1859-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00228-015-1859-2$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,777,781,27905,27906,41469,42538,51300</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25953736$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Soto, Gustavo Adolfo Centeno</creatorcontrib><creatorcontrib>Ruiz-Antorán, Belén</creatorcontrib><creatorcontrib>Laporta, Rosalía</creatorcontrib><creatorcontrib>Sancho, Arantxa</creatorcontrib><creatorcontrib>Lázaro, María Teresa</creatorcontrib><creatorcontrib>Herrera, Concepción Payares</creatorcontrib><creatorcontrib>Salcedo, Isabel</creatorcontrib><creatorcontrib>Cos, Maria Angeles</creatorcontrib><creatorcontrib>Torres, Ferrán</creatorcontrib><creatorcontrib>Usetti, Piedad</creatorcontrib><creatorcontrib>Avendaño-Sola, Cristina</creatorcontrib><title>Dose increase needed in most cystic fibrosis lung transplantation patients when changing from twice- to once-daily tacrolimus oral administration</title><title>European journal of clinical pharmacology</title><addtitle>Eur J Clin Pharmacol</addtitle><addtitle>Eur J Clin Pharmacol</addtitle><description>Aim
The aim of this pharmacokinetic (PK) study was to evaluate tacrolimus (TAC) exposure in stable cystic fibrosis (CF) lung transplant (LT) recipients, converted from TAC twice daily to TAC once daily in an open-label, prospective, single-centre study.
Methods
Eligible patients were post-transplant CF patients (18–65 years) with stable lung function, on stable doses of TAC twice daily and who were candidates to switch to TAC once daily. Twelve consecutive patients were included in the study. Patients had their first PK analysis on day 1, still under the stable TAC twice-daily regimen, and were converted to TAC once daily from day 2 onwards. The doses were adjusted according to clinical judgement to achieve target levels, and a second 24-h PK period profile was obtained once the patient was on a stable dosage on the therapeutic range.
Results
The mean total (SD) daily dose of TAC twice daily at baseline upon enrolment was 0.17 (0.10) mg/kg/day. The mean (SD) daily dose of TAC once daily after adjustments was 0.22 (0.12) mg/kg/day. In order to achieve target
C
min
levels with a similar AUC
0–24
, 82 % of subjects who were converted to TAC once daily required an increase of dose, in a range of 0–66.7 %, with a mean dose increase of 28 %.
Conclusions
Our study results indicate that the switch for conversion from TAC twice daily to TAC once daily in patients with CF may need dose adjustment in order to reach levels within the therapeutic target.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Area Under Curve</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cystic fibrosis</subject><subject>Cystic Fibrosis - metabolism</subject><subject>Cystic Fibrosis - physiopathology</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - pharmacokinetics</subject><subject>Lung Transplantation - methods</subject><subject>Lungs</subject><subject>Male</subject><subject>Pharmacokinetics and Disposition</subject><subject>Pharmacology</subject><subject>Pharmacology/Toxicology</subject><subject>Tacrolimus - administration & dosage</subject><subject>Tacrolimus - pharmacokinetics</subject><subject>Transplants & implants</subject><subject>Young Adult</subject><issn>0031-6970</issn><issn>1432-1041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kcFuFDEMhiMEokvbB-CCInHhMuAkO8nkiFoKSJW49D7KZDzbVDPJEmdU7WPwxmS1pUJInGwrn3_H_hl7K-CjADCfCEDKrgHRNqJrbSNfsI3YKtkI2IqXbAOgRKOtgTP2hugBKmhBvWZnsrWtMkpv2K_rRMhD9BldTSLiiGOt-ZKocH-gEjyfwpATBeLzGne8ZBdpP7tYXAkp8n0NGAvxx3uM3N-7uAsVm3JaeHkMHhteEk-xJqML84EX53Oaw7IST9nN3I1LiIGq7lHvgr2a3Ex4-RTP2d3Nl7urb83tj6_frz7fNl4ZWRrfuS10Bq0YLTgNg9Hd6AVoPZkBLAy61VPnjRn9NDjpUYyTAodGCYt6Uufsw0l2n9PPFan0SyCPc90L00q90J2QbWfVtqLv_0Ef0ppj_dyRAt3aestKiRNVlyPKOPX7HBaXD72A_mhXf7Krry70R7t6WXvePSmvw4Ljc8cffyogTwDVp7jD_Nfo_6r-Brjpox0</recordid><startdate>20150601</startdate><enddate>20150601</enddate><creator>Soto, Gustavo Adolfo Centeno</creator><creator>Ruiz-Antorán, Belén</creator><creator>Laporta, Rosalía</creator><creator>Sancho, Arantxa</creator><creator>Lázaro, María Teresa</creator><creator>Herrera, Concepción Payares</creator><creator>Salcedo, Isabel</creator><creator>Cos, Maria Angeles</creator><creator>Torres, Ferrán</creator><creator>Usetti, Piedad</creator><creator>Avendaño-Sola, Cristina</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><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>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20150601</creationdate><title>Dose increase needed in most cystic fibrosis lung transplantation patients when changing from twice- to once-daily tacrolimus oral administration</title><author>Soto, Gustavo Adolfo Centeno ; Ruiz-Antorán, Belén ; Laporta, Rosalía ; Sancho, Arantxa ; Lázaro, María Teresa ; Herrera, Concepción Payares ; Salcedo, Isabel ; Cos, Maria Angeles ; Torres, Ferrán ; Usetti, Piedad ; Avendaño-Sola, Cristina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-c8a4087e91d90a60b768dc1066f7b090b656f8c77dcfba2ce1df30ae7319e6f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Area Under Curve</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cystic fibrosis</topic><topic>Cystic Fibrosis - metabolism</topic><topic>Cystic Fibrosis - physiopathology</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - pharmacokinetics</topic><topic>Lung Transplantation - methods</topic><topic>Lungs</topic><topic>Male</topic><topic>Pharmacokinetics and Disposition</topic><topic>Pharmacology</topic><topic>Pharmacology/Toxicology</topic><topic>Tacrolimus - administration & dosage</topic><topic>Tacrolimus - pharmacokinetics</topic><topic>Transplants & implants</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Soto, Gustavo Adolfo Centeno</creatorcontrib><creatorcontrib>Ruiz-Antorán, Belén</creatorcontrib><creatorcontrib>Laporta, Rosalía</creatorcontrib><creatorcontrib>Sancho, Arantxa</creatorcontrib><creatorcontrib>Lázaro, María Teresa</creatorcontrib><creatorcontrib>Herrera, Concepción Payares</creatorcontrib><creatorcontrib>Salcedo, Isabel</creatorcontrib><creatorcontrib>Cos, Maria Angeles</creatorcontrib><creatorcontrib>Torres, Ferrán</creatorcontrib><creatorcontrib>Usetti, Piedad</creatorcontrib><creatorcontrib>Avendaño-Sola, Cristina</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Soto, Gustavo Adolfo Centeno</au><au>Ruiz-Antorán, Belén</au><au>Laporta, Rosalía</au><au>Sancho, Arantxa</au><au>Lázaro, María Teresa</au><au>Herrera, Concepción Payares</au><au>Salcedo, Isabel</au><au>Cos, Maria Angeles</au><au>Torres, Ferrán</au><au>Usetti, Piedad</au><au>Avendaño-Sola, Cristina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dose increase needed in most cystic fibrosis lung transplantation patients when changing from twice- to once-daily tacrolimus oral administration</atitle><jtitle>European journal of clinical pharmacology</jtitle><stitle>Eur J Clin Pharmacol</stitle><addtitle>Eur J Clin Pharmacol</addtitle><date>2015-06-01</date><risdate>2015</risdate><volume>71</volume><issue>6</issue><spage>715</spage><epage>722</epage><pages>715-722</pages><issn>0031-6970</issn><eissn>1432-1041</eissn><abstract>Aim
The aim of this pharmacokinetic (PK) study was to evaluate tacrolimus (TAC) exposure in stable cystic fibrosis (CF) lung transplant (LT) recipients, converted from TAC twice daily to TAC once daily in an open-label, prospective, single-centre study.
Methods
Eligible patients were post-transplant CF patients (18–65 years) with stable lung function, on stable doses of TAC twice daily and who were candidates to switch to TAC once daily. Twelve consecutive patients were included in the study. Patients had their first PK analysis on day 1, still under the stable TAC twice-daily regimen, and were converted to TAC once daily from day 2 onwards. The doses were adjusted according to clinical judgement to achieve target levels, and a second 24-h PK period profile was obtained once the patient was on a stable dosage on the therapeutic range.
Results
The mean total (SD) daily dose of TAC twice daily at baseline upon enrolment was 0.17 (0.10) mg/kg/day. The mean (SD) daily dose of TAC once daily after adjustments was 0.22 (0.12) mg/kg/day. In order to achieve target
C
min
levels with a similar AUC
0–24
, 82 % of subjects who were converted to TAC once daily required an increase of dose, in a range of 0–66.7 %, with a mean dose increase of 28 %.
Conclusions
Our study results indicate that the switch for conversion from TAC twice daily to TAC once daily in patients with CF may need dose adjustment in order to reach levels within the therapeutic target.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>25953736</pmid><doi>10.1007/s00228-015-1859-2</doi><tpages>8</tpages></addata></record> |
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subjects | Administration, Oral Adult Area Under Curve Biomedical and Life Sciences Biomedicine Cystic fibrosis Cystic Fibrosis - metabolism Cystic Fibrosis - physiopathology Drug Administration Schedule Drug therapy Female Humans Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - pharmacokinetics Lung Transplantation - methods Lungs Male Pharmacokinetics and Disposition Pharmacology Pharmacology/Toxicology Tacrolimus - administration & dosage Tacrolimus - pharmacokinetics Transplants & implants Young Adult |
title | Dose increase needed in most cystic fibrosis lung transplantation patients when changing from twice- to once-daily tacrolimus oral administration |
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