Population modeling and simulation study of the pharmacokinetics and antituberculosis pharmacodynamics of isoniazid in lungs.
Identifieur interne : 002897 ( PubMed/Curation ); précédent : 002896; suivant : 002898Population modeling and simulation study of the pharmacokinetics and antituberculosis pharmacodynamics of isoniazid in lungs.
Auteurs : L. Lalande [France] ; L. Bourguignon [France] ; S. Bihari [Australie] ; P. Maire [France] ; M. Neely [États-Unis] ; R. Jelliffe [États-Unis] ; S. Goutelle [France]Source :
- Antimicrobial agents and chemotherapy [ 1098-6596 ] ; 2015.
Descripteurs français
- KwdFr :
- MESH :
- métabolisme : Poumon.
- pharmacocinétique : Antituberculeux, Isoniazide.
- Adulte, Femelle, Humains, Modèles théoriques, Mâle, Méthode de Monte-Carlo, Études rétrospectives.
English descriptors
- KwdEn :
- MESH :
- chemical , pharmacokinetics : Antitubercular Agents, Isoniazid.
- metabolism : Lung.
- Adult, Female, Humans, Male, Models, Theoretical, Monte Carlo Method, Retrospective Studies.
Abstract
Among first-line antituberculosis drugs, isoniazid (INH) displays the greatest early bactericidal activity (EBA) and is key to reducing contagiousness in treated patients. The pulmonary pharmacokinetics and pharmacodynamics of INH have not been fully characterized with modeling and simulation approaches. INH concentrations measured in plasma, epithelial lining fluid, and alveolar cells for 89 patients, including fast acetylators (FAs) and slow acetylators (SAs), were modeled by use of population pharmacokinetic modeling. Then the model was used to simulate the EBA of INH in lungs and to investigate the influences of INH dose, acetylator status, and M. tuberculosis MIC on this effect. A three-compartment model adequately described INH concentrations in plasma and lungs. With an MIC of 0.0625 mg/liter, simulations showed that the mean bactericidal effect of a standard 300-mg daily dose of INH was only 11% lower for FA subjects than for SA subjects and that dose increases had little influence on the effects in either FA or SA subjects. With an MIC value of 1 mg/liter, the mean bactericidal effect associated with a 300-mg daily dose of INH in SA subjects was 41% greater than that in FA subjects. With the same MIC, increasing the daily INH dose from 300 mg to 450 mg resulted in a 22% increase in FA subjects. These results suggest that patients infected with M. tuberculosis with low-level resistance, especially FA patients, may benefit from higher INH doses, while dose adjustment for acetylator status has no significant impact on the EBA in patients with low-MIC strains.
DOI: 10.1128/AAC.00462-15
PubMed: 26077251
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Lalande</name><affiliation wicri:level="1"><nlm:affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France laure.lalande@chu-lyon.fr sylvain.goutelle@chu-lyon.fr.</nlm:affiliation><country wicri:rule="url">France</country><wicri:regionArea>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne</wicri:regionArea></affiliation></author><author><name sortKey="Bourguignon, L" sort="Bourguignon, L" uniqKey="Bourguignon L" first="L" last="Bourguignon">L. Bourguignon</name><affiliation wicri:level="1"><nlm:affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon</wicri:regionArea></affiliation></author><author><name sortKey="Bihari, S" sort="Bihari, S" uniqKey="Bihari S" first="S" last="Bihari">S. Bihari</name><affiliation wicri:level="1"><nlm:affiliation>Department of Critical Care Medicine, Flinders Medical Centre and Flinders University, Bedford Park, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Critical Care Medicine, Flinders Medical Centre and Flinders University, Bedford Park, South Australia</wicri:regionArea></affiliation></author><author><name sortKey="Maire, P" sort="Maire, P" uniqKey="Maire P" first="P" last="Maire">P. Maire</name><affiliation wicri:level="1"><nlm:affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon</wicri:regionArea></affiliation></author><author><name sortKey="Neely, M" sort="Neely, M" uniqKey="Neely M" first="M" last="Neely">M. Neely</name><affiliation wicri:level="1"><nlm:affiliation>Laboratory of Applied Pharmacokinetics, University of Southern California, Children's Hospital of Los Angeles, Los Angeles, California, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Laboratory of Applied Pharmacokinetics, University of Southern California, Children's Hospital of Los Angeles, Los Angeles, California</wicri:regionArea></affiliation></author><author><name sortKey="Jelliffe, R" sort="Jelliffe, R" uniqKey="Jelliffe R" first="R" last="Jelliffe">R. Jelliffe</name><affiliation wicri:level="1"><nlm:affiliation>Laboratory of Applied Pharmacokinetics, University of Southern California, Children's Hospital of Los Angeles, Los Angeles, California, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Laboratory of Applied Pharmacokinetics, University of Southern California, Children's Hospital of Los Angeles, Los Angeles, California</wicri:regionArea></affiliation></author><author><name sortKey="Goutelle, S" sort="Goutelle, S" uniqKey="Goutelle S" first="S" last="Goutelle">S. Goutelle</name><affiliation wicri:level="1"><nlm:affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon, France Université Lyon 1, Faculté de Pharmacie, Lyon, France laure.lalande@chu-lyon.fr sylvain.goutelle@chu-lyon.fr.</nlm:affiliation><country wicri:rule="url">France</country><wicri:regionArea>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon, France Université Lyon 1, Faculté de Pharmacie, Lyon</wicri:regionArea></affiliation></author></analytic><series><title level="j">Antimicrobial agents and chemotherapy</title><idno type="eISSN">1098-6596</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Antitubercular Agents (pharmacokinetics)</term><term>Female</term><term>Humans</term><term>Isoniazid (pharmacokinetics)</term><term>Lung (metabolism)</term><term>Male</term><term>Models, Theoretical</term><term>Monte Carlo Method</term><term>Retrospective Studies</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Antituberculeux (pharmacocinétique)</term><term>Femelle</term><term>Humains</term><term>Isoniazide (pharmacocinétique)</term><term>Modèles théoriques</term><term>Mâle</term><term>Méthode de Monte-Carlo</term><term>Poumon (métabolisme)</term><term>Études rétrospectives</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Antitubercular Agents</term><term>Isoniazid</term></keywords><keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Lung</term></keywords><keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Poumon</term></keywords><keywords scheme="MESH" qualifier="pharmacocinétique" xml:lang="fr"><term>Antituberculeux</term><term>Isoniazide</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Female</term><term>Humans</term><term>Male</term><term>Models, Theoretical</term><term>Monte Carlo Method</term><term>Retrospective Studies</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Femelle</term><term>Humains</term><term>Modèles théoriques</term><term>Mâle</term><term>Méthode de Monte-Carlo</term><term>Études rétrospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Among first-line antituberculosis drugs, isoniazid (INH) displays the greatest early bactericidal activity (EBA) and is key to reducing contagiousness in treated patients. The pulmonary pharmacokinetics and pharmacodynamics of INH have not been fully characterized with modeling and simulation approaches. INH concentrations measured in plasma, epithelial lining fluid, and alveolar cells for 89 patients, including fast acetylators (FAs) and slow acetylators (SAs), were modeled by use of population pharmacokinetic modeling. Then the model was used to simulate the EBA of INH in lungs and to investigate the influences of INH dose, acetylator status, and M. tuberculosis MIC on this effect. A three-compartment model adequately described INH concentrations in plasma and lungs. With an MIC of 0.0625 mg/liter, simulations showed that the mean bactericidal effect of a standard 300-mg daily dose of INH was only 11% lower for FA subjects than for SA subjects and that dose increases had little influence on the effects in either FA or SA subjects. With an MIC value of 1 mg/liter, the mean bactericidal effect associated with a 300-mg daily dose of INH in SA subjects was 41% greater than that in FA subjects. With the same MIC, increasing the daily INH dose from 300 mg to 450 mg resulted in a 22% increase in FA subjects. These results suggest that patients infected with M. tuberculosis with low-level resistance, especially FA patients, may benefit from higher INH doses, while dose adjustment for acetylator status has no significant impact on the EBA in patients with low-MIC strains.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26077251</PMID><DateCreated><Year>2015</Year><Month>08</Month><Day>15</Day></DateCreated><DateCompleted><Year>2016</Year><Month>05</Month><Day>18</Day></DateCompleted><DateRevised><Year>2016</Year><Month>03</Month><Day>01</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1098-6596</ISSN><JournalIssue CitedMedium="Internet"><Volume>59</Volume><Issue>9</Issue><PubDate><Year>2015</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Antimicrobial agents and chemotherapy</Title><ISOAbbreviation>Antimicrob. Agents Chemother.</ISOAbbreviation></Journal><ArticleTitle>Population modeling and simulation study of the pharmacokinetics and antituberculosis pharmacodynamics of isoniazid in lungs.</ArticleTitle><Pagination><MedlinePgn>5181-9</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1128/AAC.00462-15</ELocationID><Abstract><AbstractText>Among first-line antituberculosis drugs, isoniazid (INH) displays the greatest early bactericidal activity (EBA) and is key to reducing contagiousness in treated patients. The pulmonary pharmacokinetics and pharmacodynamics of INH have not been fully characterized with modeling and simulation approaches. INH concentrations measured in plasma, epithelial lining fluid, and alveolar cells for 89 patients, including fast acetylators (FAs) and slow acetylators (SAs), were modeled by use of population pharmacokinetic modeling. Then the model was used to simulate the EBA of INH in lungs and to investigate the influences of INH dose, acetylator status, and M. tuberculosis MIC on this effect. A three-compartment model adequately described INH concentrations in plasma and lungs. With an MIC of 0.0625 mg/liter, simulations showed that the mean bactericidal effect of a standard 300-mg daily dose of INH was only 11% lower for FA subjects than for SA subjects and that dose increases had little influence on the effects in either FA or SA subjects. With an MIC value of 1 mg/liter, the mean bactericidal effect associated with a 300-mg daily dose of INH in SA subjects was 41% greater than that in FA subjects. With the same MIC, increasing the daily INH dose from 300 mg to 450 mg resulted in a 22% increase in FA subjects. These results suggest that patients infected with M. tuberculosis with low-level resistance, especially FA patients, may benefit from higher INH doses, while dose adjustment for acetylator status has no significant impact on the EBA in patients with low-MIC strains.</AbstractText><CopyrightInformation>Copyright © 2015, American Society for Microbiology. All Rights Reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lalande</LastName><ForeName>L</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France laure.lalande@chu-lyon.fr sylvain.goutelle@chu-lyon.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bourguignon</LastName><ForeName>L</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bihari</LastName><ForeName>S</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Critical Care Medicine, Flinders Medical Centre and Flinders University, Bedford Park, South Australia, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maire</LastName><ForeName>P</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Neely</LastName><ForeName>M</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Laboratory of Applied Pharmacokinetics, University of Southern California, Children's Hospital of Los Angeles, Los Angeles, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jelliffe</LastName><ForeName>R</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Laboratory of Applied Pharmacokinetics, University of Southern California, Children's Hospital of Los Angeles, Los Angeles, California, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goutelle</LastName><ForeName>S</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Université Lyon 1, UMR CNRS 5558, Biométrie et Biologie Evolutive, Villeurbanne, France Hospices Civils de Lyon, Hôpital P. Garraud, Service Pharmaceutique, Lyon, France Université Lyon 1, Faculté de Pharmacie, Lyon, France laure.lalande@chu-lyon.fr sylvain.goutelle@chu-lyon.fr.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>06</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Antimicrob Agents Chemother</MedlineTA><NlmUniqueID>0315061</NlmUniqueID><ISSNLinking>0066-4804</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000995">Antitubercular Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>V83O1VOZ8L</RegistryNumber><NameOfSubstance UI="D007538">Isoniazid</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections 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Version="1">18626188</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Tuberculosis (Edinb). 2008 Aug;88 Suppl 1:S75-83</RefSource><PMID Version="1">18762155</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Antimicrob Agents Chemother. 2014 Oct;58(10):6111-5</RefSource><PMID Version="1">25092691</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000995" MajorTopicYN="N">Antitubercular Agents</DescriptorName><QualifierName UI="Q000493" MajorTopicYN="Y">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007538" MajorTopicYN="N">Isoniazid</DescriptorName><QualifierName 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