Evidence map›Paper›PMID 31981103›Full record

ArticleClinical pharmacokinetics2020

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

Ruben van der Galiën, Natasha Van't Boveneind-Vrubleuskaya, Charles Peloquin, Alena Skrahina, Daan J Touw, Jan-Willem C Alffenaar

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In one paragraph

Article in Clinical pharmacokinetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.3field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 4 countries.

Ruben van der GaliënDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.
Natasha Van't Boveneind-VrubleuskayaDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.
Charles PeloquinInfectious Disease Pharmacokinetics Laboratory, College of Pharmacy, and Emerging Pathogens Institute, University of Florida, Gainesville, FL, USA.
Alena SkrahinaRepublican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Republic of Belarus.
Daan J TouwDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.
Jan-Willem C AlffenaarDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands. johannes.alffenaar@sydney.edu.au.ORCID 0000-0001-6703-0288
University Medical Center Groningen · NLRepublican Scientific and Practical Centre of Pulmonology and Tuberculosis · BYThe University of Sydney · AUUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveMultidrug-resistant tuberculosis has much poorer treatment outcomes compared with drug-susceptible tuberculosis because second-line drugs for treating multidrug resistant tuberculosis are less effective and are frequently associated with side effects. Optimization of drug treatment is urgently needed. Cycloserine is a second-line tuberculosis drug with variable pharmacokinetics and thus variable exposure when programmatic doses are used. The objective of this study was to develop a population pharmacokinetic model of cycloserine to assess drug exposure and to develop a limited sampling strategy for cycloserine exposure monitoring. MATERIAL AND

methodsPatients with multidrug-/extensively drug-resistant tuberculosis who were treated for > 7 days with cycloserine were eligible for inclusion. Patients received cycloserine 500 mg (body weight ≤ 50 kg) or 750 mg (body weight > 50 kg) once daily. MW/Pharm 3.83 (Mediware, Groningen, The Netherlands) was used to parameterize the population pharmacokinetic model. The model was compared with pharmacokinetic values from the literature and evaluated with a bootstrap analysis, Monte Carlo simulation, and an external dataset. Monte Carlo simulations were used to develop a limited sampling strategy.

resultsCycloserine plasma concentration vs time curves were obtained from 15 hospitalized patients (nine male, six female, median age 35 years). Mean dose/kg body weight was 11.5 mg/kg (standard deviation 2.04 mg/kg). Median area under the concentration-time curve over 24 h (AUC

conclusionsThis developed population pharmacokinetic model can be used to calculate cycloserine concentrations and exposure in patients with multidrug-/extensively drug-resistant tuberculosis. This model was successfully validated by internal and external validation methods. This study showed that the AUC

Indexed as

Extensively Drug-Resistant TuberculosisTuberculosis, Multidrug-ResistantAdultAntibiotics, AntitubercularCycloserineFemaleHumansMaleMicrobial Sensitivity TestsAntibiotics, AntitubercularCycloserine

Identifiers

PMID31981103
OpenAlexW3001399479

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.