Population pharmacokinetics of amikacin administered once daily in patients with different renal functions
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The aim of this work was to evaluate the pharmacokinetics of amikacin in Mexican patients with different renal functions receiving once-daily dosing regimens and the influence of clinical and demographical covariates that may influence the optimization of this antibiotic. A prospective study was performed in a total of 63 patients with at least one determination of amikacin plasma concentration. Population pharmacokinetic (PK) parameters were estimated by nonlinear mixed-effects modeling; validations were performed for dosing recommendation purposes based on PK/pharmacodynamic simulations. The concentration-versus-time data were best described by a one-compartment open model with proportional interindividual variability associated with amikacin clearance (CL) and volume of distribution (V); residual error followed a homoscedastic trend. Creatinine clearance (CLCR) and ideal body weight (IBW) demonstrated significant influence on amikacin CL and V, respectively. The final model [CL (liters/h)=7.1 × (CLCR/130)0.84 and V (liters) = 20.3 × (IBW/68)2.9] showed a mean prediction error of 0.11 mg/liter (95%25 confidence interval, -3.34, 3.55) in the validation performed in a different group of patients with similar characteristics. There is a wide variability in amikacin PK parameters in Mexican patients. This leads to inadequate dosing regimens, especially in patients with augmented renal clearance (CLCR of >130 ml/min). Optimization based on the final population PK model in Mexican patients may be useful, since reliability and clinical applicability have been demonstrated in this study. © 2020 American Society for Microbiology. All Rights Reserved.
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Amikacin; Augmented renal clearance; PK/PD modeling; Population pharmacokinetics amikacin; adult; Article; compartment model; creatinine clearance; demography; drug blood level; drug clearance; drug distribution; evaluation study; female; human; ideal body weight; kidney function; major clinical study; male; maximum concentration; Mexican; minimum concentration; nonlinear system; observational study; pharmacokinetic parameters; plasma concentration-time curve; predictive value; priority journal; prospective study; trend study
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