Pharmacokinetic Modeling, Simulation, and Development of a Limited Sampling Strategy of Cycloserine in Patients with Multidrug-/Extensively Drug-Resistant Tuberculosis

Galiën, Ruben van der; Boveneind-Vrubleuskaya, Natasha van’t; Peloquin, Charles A.; Skrahina, Alena; Touw, Daan; Alffenaar, Jan-Willem

doi:10.1007/s40262-020-00860-8

Cited by 13 publications

(6 citation statements)

References 37 publications

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“… 26 In consideration of adverse effects, especially psychological effects, a population pharmacokinetic model for Cs should be developed to decide the optimal doses of Cs to DST in vitro to guide the regimen making for clinics. 27 For Eto and second-line injectable agents, we also did not found the correlation of their MIC values with the treatment outcome, which might be due to low dose or other unaccountable reasons.…”

Section: Discussioncontrasting

confidence: 57%

The Correlations of Minimal Inhibitory Concentration Values of Anti-TB Drugs with Treatment Outcomes and Clinical Profiles in Patients with Multidrug-Resistant Tuberculosis (MDR-TB) in China

Tang¹,

Kang²,

Sun³

et al. 2022

IDR

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Objective It is a challenge to obtain satisfactory treatment outcomes for patients with multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB); the study aims to correlate the Minimum Inhibitory Concentration (MIC) value of drugs with the outcome of patients with MDR/RR-TB to obtain an understanding for better regimens and optimal outcomes. Methods The patients diagnosed with MDR/RR-TB were retrospectively enrolled from January 1, 2018 to December 31, 2019, recorded clinical characteristics, MIC DST (Drug Susceptibility Test) results, and followed the treatment outcome. The data were analyzed on the correlations of MIC DST values with outcomes and clinical characteristics. Results A total of 276 patients with MDR/RR-TB were included, containing 98 cases (35.5%) with newly treated patients and 178 cases (64.5%) with re-treated patients. A total of 220 cases recorded treatment success (79.7%) and 49 cases recorded treatment failure or died. MIC values of isoniazid (H), moxifloxacin (Mfx), and ethionamide (Eto) in newly treated patients were lower than those in retreated patients, and resistance levels of Mfx and H were closely associated with the treatment outcome (P < 0.05) while those of other drugs had no close association with treatment outcome. Conclusions MIC values of some anti-TB drugs, such as fluoroquinolones (FQs) and H, can reflect the treatment outcome for patients with MDR/RR-TB, which can contribute to making regimens for better treatment outcomes.

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Section: Discussioncontrasting

confidence: 57%

The Correlations of Minimal Inhibitory Concentration Values of Anti-TB Drugs with Treatment Outcomes and Clinical Profiles in Patients with Multidrug-Resistant Tuberculosis (MDR-TB) in China

Tang¹,

Kang²,

Sun³

et al. 2022

IDR

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“…To solve this problem, the limited sampling strategy (LSS), estimating AUC with one or a few samples, would be suitable in the clinic (David and Johnston, 2000). It has been proposed for TDM of many drugs, such as mycophenolate mofetil and colistin (Zhang et al, 2018;Kim et al, 2019;Van Der Galiën et al, 2020). However, no LSS report is available for polymyxin B at present.…”

Section: Introductionmentioning

confidence: 99%

Population Pharmacokinetics and Limited Sampling Strategy for Therapeutic Drug Monitoring of Polymyxin B in Chinese Patients With Multidrug-Resistant Gram-Negative Bacterial Infections

et al. 2020

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Polymyxin B is used as a last therapeutic option for the treatment of multidrug-resistant Gram-negative bacterial infections. This study aimed to develop a population pharmacokinetic model and limited sampling strategy, a method to estimate the area under the concentration curve (AUC) by using a limited number of samples, to assist therapeutic drug monitoring of polymyxin B in Chinese patients. Population pharmacokinetic analysis was performed using Phoenix ® NLME with data obtained from 46 adult patients at steady state. Various demographic variables were investigated as potential covariates for population pharmacokinetic modeling. The limited sampling strategies based on the Bayesian approach and multiple linear regression were validated using the intraclass correlation coefficient and Bland-Altman analysis. As a result, the data was described by a two-compartment population pharmacokinetic model. Through the modeling, creatinine clearance was found to be a statistically significant covariate influencing polymyxin B clearance. The limited sampling strategies showed the twopoint model (C 0h and C 2h) could predict polymyxin B exposure with good linear relativity (r 2 > 0.98), and the four-point model (C 1h , C1 .5h , C 4h , and C 8h) performed best in predicting polymyxin B AUC (r 2 > 0.99). In conclusion, this study successfully developed a population pharmacokinetic model and limited sampling strategies that could be applied in clinical practice to assist in therapeutic drug monitoring of polymyxin B in Chinese patients.

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“…The study of van der Galiën et al [32] was performed on patients. The quality of the study was rated fair to good (13/18).…”

Section: Kineticsmentioning

confidence: 99%

Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data

2023

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Infants of mothers treated for tuberculosis might be exposed to drugs via breast milk. The existing information on the exposure of breastfed infants lacks a critical review of the published data. We aimed to evaluate the quality of the existing data on antituberculosis (anti-TB) drug concentrations in the plasma and milk as a methodologically sound basis for the potential risk of breastfeeding under therapy. We performed a systematic search in PubMed for bedaquiline, clofazimine, cycloserine/terizidone, levofloxacin, linezolid, pretomanid/pa824, pyrazinamide, streptomycin, ethambutol, rifampicin and isoniazid, supplemented with update references found in LactMed®. We calculated the external infant exposure (EID) for each drug and compared it with the recommended WHO dose for infants (relative external infant dose) and assessed their potential to elicit adverse effects in the breastfed infant. Breast milk concentration data were mainly not satisfactory to properly estimate the EID. Most of the studies suffer from limitations in the sample collection, quantity, timing and study design. Infant plasma concentrations are extremely scarce and very little data exist documenting the clinical outcome in exposed infants. Concerns for potential adverse effects in breastfed infants could be ruled out for bedaquiline, cycloserine/terizidone, linezolid and pyrazinamide. Adequate studies should be performed covering the scenario in treated mothers, breast milk and infants.

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Pharmacokinetic Modeling, Simulation, and Development of a Limited Sampling Strategy of Cycloserine in Patients with Multidrug-/Extensively Drug-Resistant Tuberculosis

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Cited by 13 publications

References 37 publications

The Correlations of Minimal Inhibitory Concentration Values of Anti-TB Drugs with Treatment Outcomes and Clinical Profiles in Patients with Multidrug-Resistant Tuberculosis (MDR-TB) in China

The Correlations of Minimal Inhibitory Concentration Values of Anti-TB Drugs with Treatment Outcomes and Clinical Profiles in Patients with Multidrug-Resistant Tuberculosis (MDR-TB) in China

Population Pharmacokinetics and Limited Sampling Strategy for Therapeutic Drug Monitoring of Polymyxin B in Chinese Patients With Multidrug-Resistant Gram-Negative Bacterial Infections

Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data

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