Cargando…

Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Tanigawara, Yusuke, Kaku, Mitsuo, Totsuka, Kyoichi, Tsuge, Hiroyuki, Saito, Atsushi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Japan 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3824208/
https://www.ncbi.nlm.nih.gov/pubmed/23529500
http://dx.doi.org/10.1007/s10156-013-0580-2
_version_ 1782290674956107776
author Tanigawara, Yusuke
Kaku, Mitsuo
Totsuka, Kyoichi
Tsuge, Hiroyuki
Saito, Atsushi
author_facet Tanigawara, Yusuke
Kaku, Mitsuo
Totsuka, Kyoichi
Tsuge, Hiroyuki
Saito, Atsushi
author_sort Tanigawara, Yusuke
collection PubMed
description 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 fAUC(0–24h)/MIC and the fC (max)/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 fAUC(0–24h)/MIC or fC (max)/MIC becomes, the higher the bacteriological efficacies. The eradication rates for fAUC(0–24h)/MIC ≥ 30 and for fC (max)/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 fAUC(0–24h)/MIC ≥ 30 and fC (max)/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.
format Online
Article
Text
id pubmed-3824208
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher Springer Japan
record_format MEDLINE/PubMed
spelling pubmed-38242082013-11-21 Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections Tanigawara, Yusuke Kaku, Mitsuo Totsuka, Kyoichi Tsuge, Hiroyuki Saito, Atsushi J Infect Chemother Original Article 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 fAUC(0–24h)/MIC and the fC (max)/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 fAUC(0–24h)/MIC or fC (max)/MIC becomes, the higher the bacteriological efficacies. The eradication rates for fAUC(0–24h)/MIC ≥ 30 and for fC (max)/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 fAUC(0–24h)/MIC ≥ 30 and fC (max)/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. Springer Japan 2013-03-26 2013 /pmc/articles/PMC3824208/ /pubmed/23529500 http://dx.doi.org/10.1007/s10156-013-0580-2 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by/2.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Article
Tanigawara, Yusuke
Kaku, Mitsuo
Totsuka, Kyoichi
Tsuge, Hiroyuki
Saito, Atsushi
Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
title Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
title_full Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
title_fullStr Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
title_full_unstemmed Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
title_short Population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
title_sort population pharmacokinetics and pharmacodynamics of sitafloxacin in patients with community-acquired respiratory tract infections
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3824208/
https://www.ncbi.nlm.nih.gov/pubmed/23529500
http://dx.doi.org/10.1007/s10156-013-0580-2
work_keys_str_mv AT tanigawarayusuke populationpharmacokineticsandpharmacodynamicsofsitafloxacininpatientswithcommunityacquiredrespiratorytractinfections
AT kakumitsuo populationpharmacokineticsandpharmacodynamicsofsitafloxacininpatientswithcommunityacquiredrespiratorytractinfections
AT totsukakyoichi populationpharmacokineticsandpharmacodynamicsofsitafloxacininpatientswithcommunityacquiredrespiratorytractinfections
AT tsugehiroyuki populationpharmacokineticsandpharmacodynamicsofsitafloxacininpatientswithcommunityacquiredrespiratorytractinfections
AT saitoatsushi populationpharmacokineticsandpharmacodynamicsofsitafloxacininpatientswithcommunityacquiredrespiratorytractinfections