Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis

Antonia Morita I Saktiawati; Marcel Harkema; Althaf Setyawan; Yanri W Subronto; [No Value] Sumardi; Ymkje Stienstra; Rob E Aarnoutse; Cecile Magis-Escurra; Jos G W Kosterink; Tjip S van der Werf; Jan-Willem C Alffenaar; Marieke G G Sturkenboom

doi:10.1007/s40262-019-00763-3

Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis

Antonia Morita I Saktiawati, Marcel Harkema, Althaf Setyawan, Yanri W Subronto, [No Value] Sumardi, Ymkje Stienstra, Rob E Aarnoutse, Cecile Magis-Escurra, Jos G W Kosterink, Tjip S van der Werf, Jan-Willem C Alffenaar, Marieke G G Sturkenboom

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Abstract

BACKGROUND: The 24-h area under the concentration-time curve (AUC24)/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC24; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs.

METHODS: An OSS for the prediction of AUC24 of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment.

RESULTS: OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS2-4-8 cannot be used for rifampicin in steady state conditions.

CONCLUSION: OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC24 values of first-line anti-TB drugs in this population.

TRIAL REGISTRATION: ClinicalTrials.gov (NCT02121314).

Original language	English
Pages (from-to)	1445-1454
Number of pages	10
Journal	Clinical Pharmacokinetics
Volume	58
Issue number	11
Early online date	10-May-2019
DOIs	https://doi.org/10.1007/s40262-019-00763-3
Publication status	Published - Nov-2019

Keywords

adult
article
controlled study
crossover procedure
drug monitoring
drug therapy
ethnicity
fasting
female
human
human tissue
jackknife test
male
multiple linear regression analysis
prediction
prospective study
randomized controlled trial
registration
sampling
steady state
tuberculosis
validation process
ethambutol
isoniazid
pyrazinamide
rifampicin

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Saktiawati, A. M. I., Harkema, M., Setyawan, A., Subronto, Y. W., Sumardi, N. V., Stienstra, Y., Aarnoutse, R. E., Magis-Escurra, C., Kosterink, J. G. W., van der Werf, T. S., Alffenaar, J.-W. C., & Sturkenboom, M. G. G. (2019). Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis. Clinical Pharmacokinetics, 58(11), 1445-1454. https://doi.org/10.1007/s40262-019-00763-3

@article{88146ce4de424fcea2b58105b64236c9,

title = "Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis",

abstract = "BACKGROUND: The 24-h area under the concentration-time curve (AUC24)/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC24; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs.METHODS: An OSS for the prediction of AUC24 of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment.RESULTS: OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS2-4-8 cannot be used for rifampicin in steady state conditions.CONCLUSION: OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC24 values of first-line anti-TB drugs in this population.TRIAL REGISTRATION: ClinicalTrials.gov (NCT02121314).",

keywords = "adult, article, controlled study, crossover procedure, drug monitoring, drug therapy, ethnicity, fasting, female, human, human tissue, jackknife test, male, multiple linear regression analysis, prediction, prospective study, randomized controlled trial, registration, sampling, steady state, tuberculosis, validation process, ethambutol, isoniazid, pyrazinamide, rifampicin",

author = "Saktiawati, {Antonia Morita I} and Marcel Harkema and Althaf Setyawan and Subronto, {Yanri W} and Sumardi, {[No Value]} and Ymkje Stienstra and Aarnoutse, {Rob E} and Cecile Magis-Escurra and Kosterink, {Jos G W} and {van der Werf}, {Tjip S} and Alffenaar, {Jan-Willem C} and Sturkenboom, {Marieke G G}",

year = "2019",

month = nov,

doi = "10.1007/s40262-019-00763-3",

language = "English",

volume = "58",

pages = "1445--1454",

journal = "Clinical Pharmacokinetics",

issn = "0312-5963",

publisher = "Springer International Publishing AG",

number = "11",

}

Saktiawati, AMI, Harkema, M, Setyawan, A, Subronto, YW, Sumardi, NV, Stienstra, Y, Aarnoutse, RE, Magis-Escurra, C, Kosterink, JGW , van der Werf, TS , Alffenaar, J-WC & Sturkenboom, MGG 2019, 'Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis', Clinical Pharmacokinetics, vol. 58, no. 11, pp. 1445-1454. https://doi.org/10.1007/s40262-019-00763-3

TY - JOUR

T1 - Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis

AU - Saktiawati, Antonia Morita I

AU - Harkema, Marcel

AU - Setyawan, Althaf

AU - Subronto, Yanri W

AU - Sumardi, [No Value]

AU - Stienstra, Ymkje

AU - Aarnoutse, Rob E

AU - Magis-Escurra, Cecile

AU - Kosterink, Jos G W

AU - van der Werf, Tjip S

AU - Alffenaar, Jan-Willem C

AU - Sturkenboom, Marieke G G

PY - 2019/11

Y1 - 2019/11

N2 - BACKGROUND: The 24-h area under the concentration-time curve (AUC24)/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC24; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs.METHODS: An OSS for the prediction of AUC24 of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment.RESULTS: OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS2-4-8 cannot be used for rifampicin in steady state conditions.CONCLUSION: OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC24 values of first-line anti-TB drugs in this population.TRIAL REGISTRATION: ClinicalTrials.gov (NCT02121314).

AB - BACKGROUND: The 24-h area under the concentration-time curve (AUC24)/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC24; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs.METHODS: An OSS for the prediction of AUC24 of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment.RESULTS: OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS2-4-8 cannot be used for rifampicin in steady state conditions.CONCLUSION: OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC24 values of first-line anti-TB drugs in this population.TRIAL REGISTRATION: ClinicalTrials.gov (NCT02121314).

KW - adult

KW - article

KW - controlled study

KW - crossover procedure

KW - drug monitoring

KW - drug therapy

KW - ethnicity

KW - fasting

KW - female

KW - human

KW - human tissue

KW - jackknife test

KW - male

KW - multiple linear regression analysis

KW - prediction

KW - prospective study

KW - randomized controlled trial

KW - registration

KW - sampling

KW - steady state

KW - tuberculosis

KW - validation process

KW - ethambutol

KW - isoniazid

KW - pyrazinamide

KW - rifampicin

U2 - 10.1007/s40262-019-00763-3

DO - 10.1007/s40262-019-00763-3

M3 - Article

C2 - 30997650

SN - 0312-5963

VL - 58

SP - 1445

EP - 1454

JO - Clinical Pharmacokinetics

JF - Clinical Pharmacokinetics

IS - 11

ER -

Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis

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