Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
Abstract An optimal dosage regimen of sitafloxacin was considered based on a pharmacokinetics and pharmacodynamics (PK–PD) analysis in patients with community-acquired respiratory tract infections (RTI). A population pharmacokinetic analysis of sitafloxacin was conducted using clinical data of five...
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Veröffentlicht in: | Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy 2013, Vol.19 (5), p.858-866 |
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description | Abstract An optimal dosage regimen of sitafloxacin was considered based on a pharmacokinetics and pharmacodynamics (PK–PD) analysis in patients with community-acquired respiratory tract infections (RTI). A population pharmacokinetic analysis of sitafloxacin was conducted using clinical data of five clinical pharmacology studies and one clinical PK–PD study in patients with RTIs. The pharmacokinetic parameters in individual patients were estimated by the Bayesian method to examine any correlation between pharmacokinetics and bacteriological efficacy. Efficacy data were obtained from the clinical PK–PD study, in which 50 or 100 mg sitafloxacin was administered twice daily for 7 days. In addition, an efficacy was simulated for a hypothetical dose regimen of 100 mg once daily. The f AUC0–24h /MIC and the fCmax /MIC of sitafloxacin at a dose of 50 mg twice daily were 117.5 ± 78.0 and 7.3 ± 4.7 (mean ± SD), respectively. As a result of the univariate logistic regression analysis, the larger the value of f AUC0–24h /MIC or fCmax /MIC becomes, the higher the bacteriological efficacies. The eradication rates for f AUC0–24h /MIC ≥ 30 and for fCmax /MIC ≥ 2 were 96.4 % and 96.3 %, respectively. The PK–PD target values of sitafloxacin for the treatment of mild to moderate RTIs were considered to be f AUC0–24h /MIC ≥ 30 and fCmax /MIC ≥ 2. The PK–PD parameters at the regimen of 50 or 100 mg twice daily in patients with RTIs reached the target values. Furthermore, a 100 mg once-daily regimen was expected to show similar efficacy based on the PK–PD simulations. |
doi_str_mv | 10.1007/s10156-013-0580-2 |
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A population pharmacokinetic analysis of sitafloxacin was conducted using clinical data of five clinical pharmacology studies and one clinical PK–PD study in patients with RTIs. The pharmacokinetic parameters in individual patients were estimated by the Bayesian method to examine any correlation between pharmacokinetics and bacteriological efficacy. Efficacy data were obtained from the clinical PK–PD study, in which 50 or 100 mg sitafloxacin was administered twice daily for 7 days. In addition, an efficacy was simulated for a hypothetical dose regimen of 100 mg once daily. The f AUC0–24h /MIC and the fCmax /MIC of sitafloxacin at a dose of 50 mg twice daily were 117.5 ± 78.0 and 7.3 ± 4.7 (mean ± SD), respectively. As a result of the univariate logistic regression analysis, the larger the value of f AUC0–24h /MIC or fCmax /MIC becomes, the higher the bacteriological efficacies. The eradication rates for f AUC0–24h /MIC ≥ 30 and for fCmax /MIC ≥ 2 were 96.4 % and 96.3 %, respectively. The PK–PD target values of sitafloxacin for the treatment of mild to moderate RTIs were considered to be f AUC0–24h /MIC ≥ 30 and fCmax /MIC ≥ 2. The PK–PD parameters at the regimen of 50 or 100 mg twice daily in patients with RTIs reached the target values. Furthermore, a 100 mg once-daily regimen was expected to show similar efficacy based on the PK–PD simulations.</description><identifier>ISSN: 1341-321X</identifier><identifier>EISSN: 1437-7780</identifier><identifier>DOI: 10.1007/s10156-013-0580-2</identifier><identifier>PMID: 23529500</identifier><language>eng</language><publisher>Tokyo: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents - blood ; Anti-Bacterial Agents - pharmacokinetics ; Anti-Bacterial Agents - pharmacology ; Anti-Bacterial Agents - therapeutic use ; Area Under Curve ; Bacteria - drug effects ; Community-Acquired Infections - drug therapy ; Community-Acquired Infections - metabolism ; Community-Acquired Infections - microbiology ; Fluoroquinolones - blood ; Fluoroquinolones - pharmacokinetics ; Fluoroquinolones - pharmacology ; Fluoroquinolones - therapeutic use ; Hematology, Oncology and Palliative Medicine ; Humans ; Infectious Diseases ; Male ; Medical Microbiology ; Medicine ; Medicine & Public Health ; Microbial Sensitivity Tests ; Middle Aged ; Optimal dosage regimen ; Original ; Original Article ; Population PK–PD ; Respiratory Tract Infections - drug therapy ; Respiratory Tract Infections - metabolism ; Respiratory Tract Infections - microbiology ; Sitafloxacin ; Virology ; Young Adult</subject><ispartof>Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy, 2013, Vol.19 (5), p.858-866</ispartof><rights>Japanese Society of Chemotherapy and the Japanese Association for Infectious Diseases</rights><rights>2013 Japanese Society of Chemotherapy and the Japanese Association for Infectious Diseases</rights><rights>The Author(s) 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c573t-be6168a91c8069a3f0bc8e0e4d303444d3fe374402a45c0c3f33d79842cd763f3</citedby><cites>FETCH-LOGICAL-c573t-be6168a91c8069a3f0bc8e0e4d303444d3fe374402a45c0c3f33d79842cd763f3</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/s10156-013-0580-2$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10156-013-0580-2$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23529500$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tanigawara, Yusuke</creatorcontrib><creatorcontrib>Kaku, Mitsuo</creatorcontrib><creatorcontrib>Totsuka, Kyoichi</creatorcontrib><creatorcontrib>Tsuge, Hiroyuki</creatorcontrib><creatorcontrib>Saito, Atsushi</creatorcontrib><title>Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections</title><title>Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy</title><addtitle>J Infect Chemother</addtitle><addtitle>J Infect Chemother</addtitle><description>Abstract An optimal dosage regimen of sitafloxacin was considered based on a pharmacokinetics and pharmacodynamics (PK–PD) analysis in patients with community-acquired respiratory tract infections (RTI). A population pharmacokinetic analysis of sitafloxacin was conducted using clinical data of five clinical pharmacology studies and one clinical PK–PD study in patients with RTIs. The pharmacokinetic parameters in individual patients were estimated by the Bayesian method to examine any correlation between pharmacokinetics and bacteriological efficacy. Efficacy data were obtained from the clinical PK–PD study, in which 50 or 100 mg sitafloxacin was administered twice daily for 7 days. In addition, an efficacy was simulated for a hypothetical dose regimen of 100 mg once daily. The f AUC0–24h /MIC and the fCmax /MIC of sitafloxacin at a dose of 50 mg twice daily were 117.5 ± 78.0 and 7.3 ± 4.7 (mean ± SD), respectively. As a result of the univariate logistic regression analysis, the larger the value of f AUC0–24h /MIC or fCmax /MIC becomes, the higher the bacteriological efficacies. The eradication rates for f AUC0–24h /MIC ≥ 30 and for fCmax /MIC ≥ 2 were 96.4 % and 96.3 %, respectively. The PK–PD target values of sitafloxacin for the treatment of mild to moderate RTIs were considered to be f AUC0–24h /MIC ≥ 30 and fCmax /MIC ≥ 2. The PK–PD parameters at the regimen of 50 or 100 mg twice daily in patients with RTIs reached the target values. Furthermore, a 100 mg once-daily regimen was expected to show similar efficacy based on the PK–PD simulations.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anti-Bacterial Agents - blood</subject><subject>Anti-Bacterial Agents - pharmacokinetics</subject><subject>Anti-Bacterial Agents - pharmacology</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Area Under Curve</subject><subject>Bacteria - drug effects</subject><subject>Community-Acquired Infections - drug therapy</subject><subject>Community-Acquired Infections - metabolism</subject><subject>Community-Acquired Infections - microbiology</subject><subject>Fluoroquinolones - blood</subject><subject>Fluoroquinolones - pharmacokinetics</subject><subject>Fluoroquinolones - pharmacology</subject><subject>Fluoroquinolones - therapeutic use</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Infectious Diseases</subject><subject>Male</subject><subject>Medical Microbiology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Microbial Sensitivity Tests</subject><subject>Middle Aged</subject><subject>Optimal dosage regimen</subject><subject>Original</subject><subject>Original Article</subject><subject>Population PK–PD</subject><subject>Respiratory Tract Infections - drug therapy</subject><subject>Respiratory Tract Infections - metabolism</subject><subject>Respiratory Tract Infections - microbiology</subject><subject>Sitafloxacin</subject><subject>Virology</subject><subject>Young Adult</subject><issn>1341-321X</issn><issn>1437-7780</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kt1qFTEQxxdRbK0-gDeyL7A6-dhNDkJBSq1CwYIteBdyZrM9aXeTNclW97JvbpbVY_WiEJhkZn4zYf5TFK8JvCUA4l0kQOqmAsIqqCVU9ElxSDgTlRASnuY746RilHw7KF7EeANARC3l8-KAsppuaoDD4v7Cj1Ovk_WuHHc6DBr9rXUmWYyldu3e2c5OD4vTd2W0SXe9_6nRujKfMfPGpVj-sGlXoh-Gydk0Vxq_TzaYtgwmjjbo5MNcpqAxZaozuHSNL4tnne6jefXbHhVXH08vTz5V51_OPp98OK-wFixVW9OQRuoNQQnNRrMOtigNGN4yYJxn0xkmOAeqeY2ArGOsFRvJKbaiya-j4nitO07bwbSYPxx0r8ZgBx1m5bVV_0ac3alrf6eYpJyCzAXIWgCDjzGYbs8SUIseatVDZT3UooeimXnzsOme-CNATqBrQswhd22CuvFTcHkQj1Z9v0Imz-vOZihiFgBNm6eNSbXePkof_0djb51F3d-a2cS__VWkCtTXZYuWJSJMAHBZs1-LxcOU</recordid><startdate>2013</startdate><enddate>2013</enddate><creator>Tanigawara, Yusuke</creator><creator>Kaku, Mitsuo</creator><creator>Totsuka, Kyoichi</creator><creator>Tsuge, Hiroyuki</creator><creator>Saito, Atsushi</creator><general>Elsevier Ltd</general><general>Springer Japan</general><scope>6I.</scope><scope>AAFTH</scope><scope>C6C</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>5PM</scope></search><sort><creationdate>2013</creationdate><title>Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections</title><author>Tanigawara, Yusuke ; Kaku, Mitsuo ; Totsuka, Kyoichi ; Tsuge, Hiroyuki ; Saito, Atsushi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c573t-be6168a91c8069a3f0bc8e0e4d303444d3fe374402a45c0c3f33d79842cd763f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anti-Bacterial Agents - blood</topic><topic>Anti-Bacterial Agents - pharmacokinetics</topic><topic>Anti-Bacterial Agents - pharmacology</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Area Under Curve</topic><topic>Bacteria - drug effects</topic><topic>Community-Acquired Infections - drug therapy</topic><topic>Community-Acquired Infections - metabolism</topic><topic>Community-Acquired Infections - microbiology</topic><topic>Fluoroquinolones - blood</topic><topic>Fluoroquinolones - pharmacokinetics</topic><topic>Fluoroquinolones - pharmacology</topic><topic>Fluoroquinolones - therapeutic use</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>Infectious Diseases</topic><topic>Male</topic><topic>Medical Microbiology</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Microbial Sensitivity Tests</topic><topic>Middle Aged</topic><topic>Optimal dosage regimen</topic><topic>Original</topic><topic>Original Article</topic><topic>Population PK–PD</topic><topic>Respiratory Tract Infections - drug therapy</topic><topic>Respiratory Tract Infections - metabolism</topic><topic>Respiratory Tract Infections - microbiology</topic><topic>Sitafloxacin</topic><topic>Virology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tanigawara, Yusuke</creatorcontrib><creatorcontrib>Kaku, Mitsuo</creatorcontrib><creatorcontrib>Totsuka, Kyoichi</creatorcontrib><creatorcontrib>Tsuge, Hiroyuki</creatorcontrib><creatorcontrib>Saito, Atsushi</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Springer Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tanigawara, Yusuke</au><au>Kaku, Mitsuo</au><au>Totsuka, Kyoichi</au><au>Tsuge, Hiroyuki</au><au>Saito, Atsushi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections</atitle><jtitle>Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy</jtitle><stitle>J Infect Chemother</stitle><addtitle>J Infect Chemother</addtitle><date>2013</date><risdate>2013</risdate><volume>19</volume><issue>5</issue><spage>858</spage><epage>866</epage><pages>858-866</pages><issn>1341-321X</issn><eissn>1437-7780</eissn><abstract>Abstract An optimal dosage regimen of sitafloxacin was considered based on a pharmacokinetics and pharmacodynamics (PK–PD) analysis in patients with community-acquired respiratory tract infections (RTI). A population pharmacokinetic analysis of sitafloxacin was conducted using clinical data of five clinical pharmacology studies and one clinical PK–PD study in patients with RTIs. The pharmacokinetic parameters in individual patients were estimated by the Bayesian method to examine any correlation between pharmacokinetics and bacteriological efficacy. Efficacy data were obtained from the clinical PK–PD study, in which 50 or 100 mg sitafloxacin was administered twice daily for 7 days. In addition, an efficacy was simulated for a hypothetical dose regimen of 100 mg once daily. The f AUC0–24h /MIC and the fCmax /MIC of sitafloxacin at a dose of 50 mg twice daily were 117.5 ± 78.0 and 7.3 ± 4.7 (mean ± SD), respectively. As a result of the univariate logistic regression analysis, the larger the value of f AUC0–24h /MIC or fCmax /MIC becomes, the higher the bacteriological efficacies. The eradication rates for f AUC0–24h /MIC ≥ 30 and for fCmax /MIC ≥ 2 were 96.4 % and 96.3 %, respectively. The PK–PD target values of sitafloxacin for the treatment of mild to moderate RTIs were considered to be f AUC0–24h /MIC ≥ 30 and fCmax /MIC ≥ 2. The PK–PD parameters at the regimen of 50 or 100 mg twice daily in patients with RTIs reached the target values. Furthermore, a 100 mg once-daily regimen was expected to show similar efficacy based on the PK–PD simulations.</abstract><cop>Tokyo</cop><pub>Elsevier Ltd</pub><pmid>23529500</pmid><doi>10.1007/s10156-013-0580-2</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged Aged, 80 and over Anti-Bacterial Agents - blood Anti-Bacterial Agents - pharmacokinetics Anti-Bacterial Agents - pharmacology Anti-Bacterial Agents - therapeutic use Area Under Curve Bacteria - drug effects Community-Acquired Infections - drug therapy Community-Acquired Infections - metabolism Community-Acquired Infections - microbiology Fluoroquinolones - blood Fluoroquinolones - pharmacokinetics Fluoroquinolones - pharmacology Fluoroquinolones - therapeutic use Hematology, Oncology and Palliative Medicine Humans Infectious Diseases Male Medical Microbiology Medicine Medicine & Public Health Microbial Sensitivity Tests Middle Aged Optimal dosage regimen Original Original Article Population PK–PD Respiratory Tract Infections - drug therapy Respiratory Tract Infections - metabolism Respiratory Tract Infections - microbiology Sitafloxacin Virology Young Adult |
title | Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections |
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