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Population pharmacokinetic and optimization of polymyxin B dosing in adult patients with various renal functions

British journal of clinical pharmacology, 2021-04, Vol.87 (4), p.1869-1877 [Peer Reviewed Journal]

2020 British Pharmacological Society ;2020 British Pharmacological Society. ;COPYRIGHT 2021 Blackwell Publishers Ltd. ;ISSN: 0306-5251 ;EISSN: 1365-2125 ;DOI: 10.1111/bcp.14576 ;PMID: 33002196

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  • Title:
    Population pharmacokinetic and optimization of polymyxin B dosing in adult patients with various renal functions
  • Author: Yu, Xu‐Ben ; Jiao, Zheng ; Zhang, Chun‐Hong ; Dai, Ying ; Zhou, Zi‐Ye ; Han, Lu ; Wen, Xin ; Sheng, Chang‐Cheng ; Lin, Guan‐Yang ; Pan, Jing‐Ye
  • Subjects: Analysis ; dose individualization ; Drug approval ; Medical research ; Medicine, Experimental ; Monte Carlo method ; pharmacokinetics ; polymyxin B
  • Is Part Of: British journal of clinical pharmacology, 2021-04, Vol.87 (4), p.1869-1877
  • Description: Aims Current FDA‐approved label recommends that the dosage of polymyxin B should be adjusted according to renal function. However, the correlation between polymyxin B pharmacokinetics (PK) and creatinine clearance (CrCL) is poor. This study aimed to develop a population PK model of polymyxin B in adult patients with various renal functions and to identify a dosing strategy. Methods A retrospective PK study was performed in 32 adult patients with various renal function. Nonlinear mixed effects modelling was applied to build a population PK model of polymyxin B followed by Monte Carlo simulations which designed polymyxin B dosing regimens across various renal function. Results Polymyxin B PK analyses included 112 polymyxin B concentrations at steady state from 32 adult patients, in which 71.9% of them were critically ill. In the final PK model, CrCL was the significant covariate on CL (typical value 1.59 L/h; between‐subject variability 13%). The mean (SD) individual empirical Bayesian estimate of CL was 1.75 (0.43) L/h. In addition, a new dosing strategy combining the PK/pharmacodynamic (PD) targets and Monte Carlo simulation indicated that the reduction of polymyxin B dose in patients with renal insufficiency improved the probability of achieving optimal exposure. For severe infections caused by organisms with minimum inhibitory concentration (MIC) ≥ 2 mg/L, a high daily dose of polymyxin B might be possible for bacterial eradication, but the risk of nephrotoxicity is increased. Conclusions Renal function plays a significant role in polymyxin B PK, and the dose of polymyxin B should be adjusted according to CrCL in patients with renal insufficiency.
  • Publisher: England: Wiley Subscription Services, Inc
  • Language: English
  • Identifier: ISSN: 0306-5251
    EISSN: 1365-2125
    DOI: 10.1111/bcp.14576
    PMID: 33002196
  • Source: Geneva Foundation Free Medical Journals at publisher websites
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