Pharmacokinetics-pharmacodynamics of first-line antitubercular drugs: a comparative study in tuberculosis patients with and without concomitant diabetes mellitus.
Purpose: To observe the variability in the plasma concentrations and pharmacokinetic-pharmacodynamic (PK-PD) profiles of first-line antitubercular drugs in pulmonary tuberculosis (TB) patients with and without diabetes mellitus (DM). Methods: Newly diagnosed pulmonary TB patients aged 18–60 years wi...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 80; no. 12; pp. 1945 - 1959 |
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| Autores principales: | , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Springer Nature
Dec2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=182280339&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 182280339 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Dec2024 vid: 80 iid: 12 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 182280339 179682854 182280339 182280339 10.1007/s00228-024-03754-x 182280339 ppf: 1945 ppct: 14 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Pharmacokinetics-pharmacodynamics of first-line antitubercular drugs: a comparative study in tuberculosis patients with and without concomitant diabetes mellitus. aug: au: Mondal, Sourav Roy, Vandana Meshram, Girish Gulab Khanna, Ashwani Velpandian, Thirumurthy Garg, Sandeep affil: https://ror.org/03dwx1z96 Department of Pharmacology, Maulana Azad Medical College, 110002, New Delhi, India sug: subj: Tuberculosis Drug Therapy Antitubercular Agents Therapeutic Use Diabetes Mellitus Tuberculosis Blood Antitubercular Agents Pharmacodynamics Antitubercular Agents Pharmacokinetics Treatment Outcomes Human Male Female Adult Middle Age Adolescence Prospective Studies Nonrandomized Trials Nonexperimental Studies Clinical Trials Comparative Studies Isoniazid Therapeutic Use Rifampin Therapeutic Use Pyrazinamide Therapeutic Use Ethambutol Therapeutic Use India Antitubercular Agents Adverse Effects Diabetic Patients Funding Source Adult: 19-44 years Middle Aged: 45-64 years Adolescent: 13-18 years Male Female ab: Purpose: To observe the variability in the plasma concentrations and pharmacokinetic-pharmacodynamic (PK-PD) profiles of first-line antitubercular drugs in pulmonary tuberculosis (TB) patients with and without diabetes mellitus (DM). Methods: Newly diagnosed pulmonary TB patients aged 18–60 years with or without DM were included in the study. Group I (n = 20) included patients with TB, whereas group II (n = 20) included patients with both TB and DM. After 2 weeks of therapy, plasma concentrations and other PK-PD parameters were determined. Improvements in clinical features, X-ray findings, sputum conversion, and adverse drug reactions (ADRs) were assessed after 2 months of therapy. Results: Isoniazid displayed non-significantly higher plasma concentrations in diabetic patients, along with a significantly (P < 0.05) longer elimination half-life (t1/2). Rifampicin plasma concentrations at 4, 8, and 12 h were significantly (P < 0.05) lower, and it displayed significantly (P < 0.05) lower area under the curve (AUC0-12 and AUC0-∞), shorter t1/2, higher clearance (Cl), and a lower AUC0-∞/MIC ratio in diabetic patients. Pyrazinamide and ethambutol showed non-significantly higher plasma concentrations, AUC0-12, AUC0-∞, and t1/2 in diabetic patients. The improvements in clinical features, X-ray findings, sputum conversion, and ADRs were comparable in both groups. Conclusions: The presence of DM in TB patients affects the PK-PD parameters of isoniazid, rifampicin, pyrazinamide, and ethambutol variably in the Indian population. Studies with a larger number of patients are required to further elucidate the role of DM on the PK-PD profile of first-line antitubercular drugs and treatment outcomes in TB patients with concomitant DM. Trial registration: CTRI/2021/08/035578 dated 11/08/2021. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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