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Pharmacology

Population Pharmacokinetics of Ethambutol in South African Tuberculosis Patients

Siv Jönsson, Alistair Davidse, Justin Wilkins, Jan-Stefan Van der Walt, Ulrika S. H. Simonsson, Mats O. Karlsson, Peter Smith, Helen McIlleron
Siv Jönsson
2Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden
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  • For correspondence: siv.jonsson@farmbio.uu.se
Alistair Davidse
1Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
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Justin Wilkins
1Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
2Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden
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Jan-Stefan Van der Walt
1Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
2Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden
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Ulrika S. H. Simonsson
2Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden
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Mats O. Karlsson
2Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden
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Peter Smith
1Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
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Helen McIlleron
1Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa
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DOI: 10.1128/AAC.00274-11
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ABSTRACT

Ethambutol, one of four drugs in the first-line antitubercular regimen, is used to protect against rifampin resistance in the event of preexisting resistance to isoniazid. The population pharmacokinetics of ethambutol in South African patients with pulmonary tuberculosis were characterized using nonlinear mixed-effects modeling. Patients from 2 centers were treated with ethambutol (800 to 1,500 mg daily) combined with standard antitubercular medication. Plasma concentrations of ethambutol were measured following multiple doses at steady state and were determined using a validated high-pressure liquid chromatography-tandem mass spectrometric method. The data comprised 189 patients (54% male, 12% HIV positive) weighing 47 kg, on average (range, 29 to 86 kg), and having a mean age of 36 years (range, 16 to 72 years). The estimated creatinine clearance was 79 ml/min (range, 23 to 150 ml/min). A two-compartment model with one transit compartment prior to first-order absorption and allometric scaling by body weight on clearance and volume terms was selected. HIV infection was associated with a 15% reduction in bioavailability. Renal function was not related to ethambutol clearance in this cohort. Interoccasion variability exceeded interindividual variability for oral clearance (coefficient of variation, 36 versus 20%). Typical oral clearance in this analysis (39.9 liters/h for a 50-kg individual) was lower than that previously reported, a finding partly explained by the differences in body weight between the studied populations. In summary, a population model describing the pharmacokinetics of ethambutol in South African tuberculosis patients was developed, but additional studies are needed to characterize the effects of renal function.

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Population Pharmacokinetics of Ethambutol in South African Tuberculosis Patients
Siv Jönsson, Alistair Davidse, Justin Wilkins, Jan-Stefan Van der Walt, Ulrika S. H. Simonsson, Mats O. Karlsson, Peter Smith, Helen McIlleron
Antimicrobial Agents and Chemotherapy Aug 2011, 55 (9) 4230-4237; DOI: 10.1128/AAC.00274-11

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Population Pharmacokinetics of Ethambutol in South African Tuberculosis Patients
Siv Jönsson, Alistair Davidse, Justin Wilkins, Jan-Stefan Van der Walt, Ulrika S. H. Simonsson, Mats O. Karlsson, Peter Smith, Helen McIlleron
Antimicrobial Agents and Chemotherapy Aug 2011, 55 (9) 4230-4237; DOI: 10.1128/AAC.00274-11
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