Simple strategy to assess linezolid exposure in patients with multi-drug-resistant and extensively-drug-resistant tuberculosis

Autor: Jasper Kamp, Onno W. Akkerman, Simon Tiberi, Wiel C M de Lange, Rosella Centis, Mathieu S. Bolhuis, Giovanni Battista Migliori, Tjip S. van der Werf, Jan-Willem C. Alffenaar, Jos G. W. Kosterink
Přispěvatelé: Guided Treatment in Optimal Selected Cancer Patients (GUTS), Biopharmaceuticals, Discovery, Design and Delivery (BDDD), Targeted Gynaecologic Oncology (TARGON), PharmacoTherapy, -Epidemiology and -Economics, Microbes in Health and Disease (MHD)
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Male
0301 basic medicine
Antitubercular Agents
Pharmacology
chemistry.chemical_compound
0302 clinical medicine
Tuberculosis
Multidrug-Resistant
Medicine
Pharmacology (medical)
Aged
80 and over
education.field_of_study
medicine.diagnostic_test
General Medicine
Middle Aged
POPULATION PHARMACOKINETICS
Infectious Diseases
Italy
Tolerability
SAFETY
Female
MYCOBACTERIUM-TUBERCULOSIS
Adult
Microbiology (medical)
medicine.medical_specialty
030106 microbiology
Population
TDM
Young Adult
03 medical and health sciences
Internal medicine
Humans
Tuberculosis
Dosing
XDR-TB
education
METAANALYSIS
Aged
Models
Statistical
COMPASSIONATE-USE PROGRAM
business.industry
Linezolid
Extensively drug-resistant tuberculosis
IN-VITRO
PHARMACODYNAMICS
medicine.disease
EFFICACY
Multi-drug resistance
030228 respiratory system
chemistry
Therapeutic drug monitoring
Pharmacodynamics
TOLERABILITY
business
Blood Chemical Analysis
Blood sampling
Zdroj: International journal of antimicrobial agents, 49(6), 688-694. Elsevier Bedrijfsinformatie b.v.
ISSN: 1872-7913
0924-8579
DOI: 10.1016/j.ijantimicag.2017.01.017
Popis: Linezolid is used increasingly for the treatment of multi-drug-resistant (MDR) and extensively-drug-resistant (XDR) tuberculosis (TB). However, linezolid can cause severe adverse events, such as peripheral and optical neuropathy or thrombocytopenia related to higher drug exposure. This study aimed to develop a population pharmacokinetic model to predict the area under the concentration curve (AUC) for linezolid using a limited number of blood samples.Data from patients with MDR-/XDR-TB who received linezolid and therapeutic drug monitoring as part of their TB treatment were used. Mw\Pharm 3.82 (Mediware, Zuidhorn, The Netherlands) was used to develop a population pharmacokinetic model and limited sampling strategy (LSS) for linezolid. LSS was evaluated over a time span of 6 h. Blood sampling directly before linezolid administration and 2 h after linezolid administration were considered to be the most clinically relevant sampling points.The model and LSS were evaluated by analysing the correlation between AUC(12h,observed) and AUC(12h,estimated). In addition, LSS was validated with an external group of patients with MDR-/XDR-TB from Sondalo, Italy.Fifty-two pharmacokinetic profiles were used to develop the model. Thirty-three profiles with a 300 mg dosing regimen and 19 profiles with a 600 mg dosing regimen were obtained. Model validation showed prediction bias of 0.1% and r(2) of 0.99. Evaluation of the most clinically relevant LSS showed prediction bias of 4.8% and r(2) of 0.97. The root mean square error corresponding to the most relevant LSS was 6.07%.The developed LSS could be used to enable concentration-guided dosing of linezolid. (C) 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.
Databáze: OpenAIRE
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