Population Pharmacokinetic Evaluation of Amikacin Liposome Inhalation Suspension in Patients with Treatment-Refractory Nontuberculous Mycobacterial Lung Disease
| Autor: | Dayton W. Yuen, Nikolas J. Onufrak, Christopher M. Rubino, Jakko van Ingen, David E. Griffith, Kevin C. Mange, Kevin L. Winthrop, Sujata M. Bhavnani |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Population Cmax Urine 030226 pharmacology & pharmacy Gastroenterology 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Internal medicine Medicine Pharmacology (medical) Dosing Original Research Article education Pharmacology education.field_of_study Inhalation business.industry lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] Amikacin 030220 oncology & carcinogenesis Sputum medicine.symptom business medicine.drug |
| Zdroj: | European Journal of Drug Metabolism and Pharmacokinetics European Journal of Drug Metabolism and Pharmacokinetics, 46, 277-287 European Journal of Drug Metabolism and Pharmacokinetics, 46, 2, pp. 277-287 |
| ISSN: | 0378-7966 |
| DOI: | 10.1007/s13318-020-00669-7 |
| Popis: | Background and Objectives Use of parenteral amikacin to treat refractory nontuberculous mycobacterial (NTM) lung disease is limited by systemic toxicity. A population pharmacokinetic model was developed using data pooled from two randomized trials to evaluate the pharmacokinetic properties of once-daily amikacin liposome inhalation suspension (ALIS) in patients with treatment-refractory NTM lung disease. Methods In phase 2 (TR02-112) and phase 3 (CONVERT) studies, patients with sputum cultures positive for Mycobacterium avium complex (both studies) or M. abscessus (TR02-112) despite ≥ 6 months of guideline-based therapy were treated with once-daily ALIS 590 mg. Results Fifty-three patients (28 Japanese; 25 White) were assessed. At baseline and ≈ 6 months after daily dosing, median maximum concentration (Cmax) was < 2 mg/L and median area under the concentration-time curve (AUC0–24) was |
| Databáze: | OpenAIRE |
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