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

Autor: Saktiawati AMI; Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.; Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia., Harkema M; Groningen, The Netherlands., Setyawan A; Department of Biostatistics, Epidemiology, and Population Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia., Subronto YW; Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.; Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia., Sumardi; Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia., Stienstra Y; Department of Internal Medicine/Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Aarnoutse RE; Department of Pharmacy, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands., Magis-Escurra C; Department of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Groesbeek, The Netherlands., Kosterink JGW; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.; Unit Pharmacotherapy, Epidemiology and Economy, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands., van der Werf TS; Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.; Department of Internal Medicine/Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Alffenaar JC; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.; Faculty of Medicine and Health, School of Pharmacy, University of Sydney, Sydney, NSW, Australia., Sturkenboom MGG; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands. m.g.g.sturkenboom@umcg.nl.
Jazyk: angličtina
Zdroj: Clinical pharmacokinetics [Clin Pharmacokinet] 2019 Nov; Vol. 58 (11), pp. 1445-1454.
DOI: 10.1007/s40262-019-00763-3
Abstrakt: Background: The 24-h area under the concentration-time curve (AUC 24 )/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 AUC 24 ; 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 AUC 24 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 OSS 2-4-8 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 AUC 24 values of first-line anti-TB drugs in this population.
Trial Registration: ClinicalTrials.gov (NCT02121314).
Databáze: MEDLINE
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