Development of a population pharmacokinetic model and Bayesian estimators for isoniazid in Tunisian tuberculosis patients.


Journal

The pharmacogenomics journal
ISSN: 1473-1150
Titre abrégé: Pharmacogenomics J
Pays: United States
ID NLM: 101083949

Informations de publication

Date de publication:
08 2021
Historique:
received: 03 08 2020
accepted: 02 02 2021
revised: 12 01 2021
pubmed: 3 3 2021
medline: 29 1 2022
entrez: 2 3 2021
Statut: ppublish

Résumé

This study aimed to develop a population pharmacokinetic model using full pharmacokinetic (PK) profiles of isoniazid (INH) taking into account demographic and genetic covariates and to develop Bayesian estimators for predicting INH area under the curve (AUC) in Tunisian tuberculosis patients. The INH concentrations in the building data set were fitted using a one- to three-compartment model. The impact of the different covariates was assessed on the PK parameters of the best model. The best limited sampling strategy (LSS) for estimating the INH AUC was selected by comparing the predicted values to an independent data set. INH PK was best described using a three-compartment model with lag-time absorption. The different studied covariates did not have any impact on the PK parameters of the building model. The Bayesian estimation using one-point concentrations gave the lowest values of prediction errors for the C

Identifiants

pubmed: 33649521
doi: 10.1038/s41397-021-00223-x
pii: 10.1038/s41397-021-00223-x
doi:

Substances chimiques

Antitubercular Agents 0
Isoniazid V83O1VOZ8L

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

467-475

Informations de copyright

© 2021. The Author(s), under exclusive licence to Springer Nature Limited part of Springer Nature.

Références

Mostowy S, Behr MA. The origin and evolution of Mycobacterium tuberculosis. Clin Chest Med. 2005;26:207–16.
doi: 10.1016/j.ccm.2005.02.004
WHO. Global tuberculosis report 2018 WHO. Available from: http://www.who.int/tb/publications/global_report/en/ . Accessed 2 Aug 2020.
DSSB. Minister of Public Health. Le guide national de prise en charge de la tuberculose édition 2018. Available from: http://www.santetunisie.rns.tn/fr/toutes-les-actualites/807-dssb-le-guide-national-de-prise-en-charge-de-la-tuberculose-%C3%A9dition-2018 . Accessed 2 Aug 2020.
WHO. International Standards for Tuberculosis Care (ISTC). Available from: http://www.who.int/tb/publications/2006/istc/en/ . Accessed 2 Aug 2020.
Sturkenboom MGG, Akkerman OW, Altena R, van, Lange WCM, de, Kosterink JGW, Werf TSvan der . et al. Dosage of isoniazid and rifampicin poorly predicts drug exposure in tuberculosis patients. Eur Respir J. 2016;48:1237–9.
doi: 10.1183/13993003.00986-2016
Jung JA, Kim T-E, Lee H, Jeong B-H, Park HY, Jeon K, et al. A proposal for an individualized pharmacogenetic-guided isoniazid dosage regimen for patients with tuberculosis. Drug Des Devel Ther. 2015;9:5433–8.
doi: 10.2147/DDDT.S87131
Ben Fredj N, Gam R, Kerkni E, Chaabane A, Chadly Z, Boughattas N, et al. Risk factors of isoniazid-induced hepatotoxicity in Tunisian tuberculosis patients. Pharmacogenomics J. 2017;17:372–7.
doi: 10.1038/tpj.2016.26
Devaleenal Daniel B, Ramachandran G, Swaminathan S. The challenges of pharmacokinetic variability of first-line anti-TB drugs. Expert Rev Clin Pharm. 2017;10:47–58.
doi: 10.1080/17512433.2017.1246179
Vuilleumier N, Rossier MF, Chiappe A, Degoumois F, Dayer P, Mermillod B, et al. CYP2E1 genotype and isoniazid-induced hepatotoxicity in patients treated for latent tuberculosis. Eur J Clin Pharm. 2006;62:423–9.
doi: 10.1007/s00228-006-0111-5
Butcher NJ, Boukouvala S, Sim E, Minchin RF. Pharmacogenetics of the arylamine N-acetyltransferases. Pharmacogenomics J. 2002;2:30–42.
doi: 10.1038/sj.tpj.6500053
van der Meer AF, Marcus MAE, Touw DJ, Proost JH, Neef C. Optimal sampling strategy development methodology using maximum a posteriori Bayesian estimation. Ther Drug Monit. 2011;33:133–46.
doi: 10.1097/FTD.0b013e31820f40f8
Kinzig-Schippers M, Tomalik-Scharte D, Jetter A, Scheidel B, Jakob V, Rodamer M, et al. Should we use N-acetyltransferase type 2 genotyping to personalize isoniazid doses? Antimicrob Agents Chemother. 2005;49:1733–8.
doi: 10.1128/AAC.49.5.1733-1738.2005
Seng K-Y, Hee K-H, Soon G-H, Chew N, Khoo SH, Lee LS-U. Population pharmacokinetic analysis of isoniazid, acetylisoniazid, and isonicotinic acid in healthy volunteers. Antimicrob Agents Chemother. 2015;59:6791–9.
doi: 10.1128/AAC.01244-15
Wilkins JJ, Langdon G, McIlleron H, Pillai G, Smith PJ, Simonsson USH. Variability in the population pharmacokinetics of isoniazid in South African tuberculosis patients. Br J Clin Pharm. 2011;72:51–62.
doi: 10.1111/j.1365-2125.2011.03940.x
Peloquin CA, Jaresko GS, Yong CL, Keung AC, Bulpitt AE, Jelliffe RW. Population pharmacokinetic modeling of isoniazid, rifampin, and pyrazinamide. Antimicrob Agents Chemother. 1997;41:2670–9.
doi: 10.1128/AAC.41.12.2670
Denti P, Jeremiah K, Chigutsa E, Faurholt-Jepsen D, PrayGod G, Range N, et al. Pharmacokinetics of isoniazid, pyrazinamide, and ethambutol in newly diagnosed pulmonary TB patients in Tanzania. PLoS ONE. 2015;10:e0141002.
doi: 10.1371/journal.pone.0141002
Naidoo A, Chirehwa M, Ramsuran V, McIlleron H, Naidoo K, Yende-Zuma N, et al. Effects of genetic variability on rifampicin and isoniazid pharmacokinetics in South African patients with recurrent tuberculosis. Pharmacogenomics. 2019;20:225–40.
doi: 10.2217/pgs-2018-0166
Cojutti P, Giangreco M, Isola M, Pea F. Limited sampling strategies for determining the area under the plasma concentration-time curve for isoniazid might be a valuable approach for optimizing treatment in adult patients with tuberculosis. Int J Antimicrob Agents. 2017;50:23–8.
doi: 10.1016/j.ijantimicag.2017.01.036
Magis-Escurra C, Later-Nijland HMJ, Alffenaar JWC, Broeders J, Burger DM, van Crevel R, et al. Population pharmacokinetics and limited sampling strategy for first-line tuberculosis drugs and moxifloxacin. Int J Antimicrob Agents. 2014;44:229–34.
doi: 10.1016/j.ijantimicag.2014.04.019
Saktiawati AMI, Harkema M, Setyawan A, Subronto YW, Sumardi, Stienstra Y, et al. Optimal sampling strategies for therapeutic drug monitoring of first-line tuberculosis drugs in patients with tuberculosis. Clin Pharmacokinet. 2019;58:1445–54.
doi: 10.1007/s40262-019-00763-3
Alshaikheid M, Ben Fredj N, Chaabane A, Chadli Z, Slama A, Boughattas N, et al. Development and validation of a chromatographic method for the quantification of Isoniazid in human plasma. J Pharm Drug Deliv Res. 2018;7:1–5.
Neely MN, van Guilder MG, Yamada WM, Schumitzky A, Jelliffe RW. Accurate detection of outliers and subpopulations with Pmetrics, a nonparametric and parametric pharmacometric modeling and simulation package for R. Ther Drug Monit. 2012;34:467–76.
doi: 10.1097/FTD.0b013e31825c4ba6
Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503–12.
doi: 10.1007/BF01060893
Riff C, Debord J, Monchaud C, Marquet P, Woillard J-B. Population pharmacokinetic model and Bayesian estimator for 2 tacrolimus formulations in adult liver transplant patients. Br J Clin Pharm. 2019;85:1740–50.
doi: 10.1111/bcp.13960
Mishra P, Albiol-Chiva J, Bose D, Durgbanshi A, Peris-Vicente J, Carda-Broch S, et al. Optimization and validation of a chromatographic method for the quantification of isoniazid in urine of tuberculosis patients according to the european medicines agency guideline. Antibiotics. 2018;7:107.
doi: 10.3390/antibiotics7040107
Holdiness MR. Clinical pharmacokinetics of the antituberculosis drugs. Clin Pharmacokinet. 1984;9:511–44.
doi: 10.2165/00003088-198409060-00003
Cho H-J, Koh W-J, Ryu Y-J, Ki C-S, Nam M-H, Kim J-W, et al. Genetic polymorphisms of NAT2 and CYP2E1 associated with antituberculosis drug-induced hepatotoxicity in Korean patients with pulmonary tuberculosis. Tuberculosis. 2007;87:551–6.
doi: 10.1016/j.tube.2007.05.012
Lee S-W, Chung LS-C, Huang H-H, Chuang T-Y, Liou Y-H, Wu LS-H. NAT2 and CYP2E1 polymorphisms and susceptibility to first-line anti-tuberculosis drug-induced hepatitis. Int J Tuberc Lung Dis. 2010;14:622–6.
pubmed: 20392357
Sheng Y-J, Wu G, He H-Y, Chen W, Zou Y-S, Li Q, et al. The association between CYP2E1 polymorphisms and hepatotoxicity due to anti-tuberculosis drugs: a meta-analysis. Infect Genet Evol. 2014;24:34–40.
doi: 10.1016/j.meegid.2014.01.034
Toure A, Cabral M, Niang A, Diop C, Garat A, Humbert L, et al. Prevention of isoniazid toxicity by NAT2 genotyping in Senegalese tuberculosis patients. Toxicol Rep. 2016;3:826–31.
doi: 10.1016/j.toxrep.2016.10.004
Vivien J, Thibier R. La pharmacocinétique de l’isoniazide dans la race blanche. Rev Mal Respir. 1973;72:753.

Auteurs

Mohammed Alshaikheid (M)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia. mohammed.alshaikheid@gmail.com.

Nadia Ben Fredj (N)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Ibtissem Hannachi (I)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Naourez Kolsi (N)

Otorhinolaryngology Department, University Hospital of Monastir, Monastir, Tunisia.

Najah Ben Fadhel (N)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Emna Kerkeni (E)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Haifa Ben Romdhane (H)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Amel Chaabane (A)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Jamel Koubaa (J)

Otorhinolaryngology Department, University Hospital of Monastir, Monastir, Tunisia.

Zohra Chadli (Z)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Karim Aouam (K)

Laboratory of Pharmacology, Faculty of Medicine of Monastir, Monastir, Tunisia.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH