Clinical Practice Guidelines for Therapeutic Drug Monitoring of Vancomycin in the Framework of Model-Informed Precision Dosing: A Consensus Review by the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring

Matsumoto, Kazuaki; Oda, Kazutaka; Shoji, Kensuke; Hanai, Yuki; Takahashi, Yoshiko; Fujii, Satoshi; Hamada, Yukihiro; Kimura, Toshimi; Mayumi, Toshihiko; Nakajima, Kazuhiko; Takesue, Yoshio

doi:10.3390/pharmaceutics14030489

Cited by 65 publications

(56 citation statements)

References 211 publications

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“…These two ranges are compared in the literature and there is no definite consensus in this regard. However, we considered AUC between 400 and 800 mg×hr/L as some studies recommended it for more serious infections (Rybak et al, 2020;Tsutsuura et al, 2021;Matsumoto et al, 2022). AUC monitoring was studied as an index measure to minimize nephrotoxicity with maximal clinical effectiveness (Finch et al, 2017;Hashimoto et al, 2021).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of vancomycin pharmacokinetics in patients with augmented renal clearances: A randomized clinical trial

et al. 2022

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Purpose: Vancomycin is a narrow therapeutic window glycopeptide antibiotic that acts against Gram-positive bacteria. As it is renally eliminated, therapeutic drug monitoring is recommended for vancomycin, especially in case of kidney function alteration. Augmented renal clearance (ARC), defined as a creatinine clearance of more than 130 ml/min, is a risk factor for sub-therapeutic concentrations of vancomycin. This study aimed to evaluate the vancomycin pharmacokinetics following the administration of two different regimens in ARC patients.Methods: A randomized clinical trial (IRCT20180802040665N1) was conducted on patients in need of vancomycin therapy. Eight hours of urine was collected and 56 patients divided into two groups with creatinine clearance of more than 130 ml/min were included in the study. The first group received 15 mg/kg of vancomycin every 12 h and the second group 15 mg/kg every 8 h. After four doses, the peak and trough concentrations were measured from two blood samples. The primary outcome was the percentage of patients who attainted AUC more than 400. The occurrence of acute kidney injury also was evaluated after seven days.Results: The mean age of patients in the every 12 h and every 8 h groups was 44.04 ± 16.55 and 42.86 ± 11.83 years, respectively. While neurosurgical issues were the most common causes of hospitalization, central nervous infections were the most common indications for vancomycin initiation. Urinary creatinine clearance was 166.94 ± 41.32 ml/min in the every 12 h group and 171.78 ± 48.56 ml/min in the every 8 h group. 46.42% of patients in the every 12 h group and 82.14% of patients in the every 8 h group attained AUC/MIC of more than 400 mg × hr/L. None of the patients in the every 12 h group reached more than 15 mcg/ml concentration. At the 7-day follow-up, 10.7% patients in the BD group and 28.6% patients in the TDS group developed acute kidney injury (p = 0.089).Conclusion: Administration of vancomycin at a dose of 15 mg/kg every 8 h is associated with higher pharmacokinetic attainment in ARC patients. The occurrence of acute kidney injury also was not significantly higher in this therapeutic regimen. AUC/MIC monitoring is necessary in this population.

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Section: Discussionmentioning

confidence: 99%

Evaluation of vancomycin pharmacokinetics in patients with augmented renal clearances: A randomized clinical trial

et al. 2022

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“…7) Thus, AUC-guided TDM is assumed to be more important in clinical practice. 8) In addition, it may be important to design a simple dosing regimen that considers a combination of factors that affect AUC (age, obesity, serum albumin, creatinine clearance (Ccr), underlying diseases, and concomitant drugs). [9][10][11][12] In our previous study, we constructed an algorithm optimized for dose setting of targeted VCM trough concentration of 10-20 mg/L using decision tree (DT) analysis.…”

Section: Introductionmentioning

confidence: 99%

“…Additionally, the establishment of a maintenance dose might be helpful as a reference for some facilities where measurement of VCM concentrations are outsourced, and early implementation of TDM have been difficulty under recommended conditions according to the guidelines. 6,8) In this study, by using DT analysis, we aimed to construct a model for estimating the VCM maintenance dose to target an AUC of 400-600 mg⋅h/L. Moreover, new guidelines recommend the AUC should be calculated by 2 points of VCM concentration.…”

Section: Introductionmentioning

confidence: 99%

Machine Learning-Based Model for Estimating Vancomycin Maintenance Dose to Target the Area under the Concentration Curve of 400–600 mg·h/L in Japanese Patients

Miyai

Imai

Yoshimura

et al. 2022

Biological & Pharmaceutical Bulletin

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In therapeutic drug monitoring of vancomycin (VCM), the area under the concentration-time curve (AUC) is related to clinical efficacy and toxicity. Determining the maintenance for patient is necessary since VCM concentrations are affected by factors such as renal function. We constructed a machine learning-based model to estimate the maintenance dose to target an AUC of 400-600 mg⋅h/L in each combination of patient's factors. This retrospective observational study was conducted at two hospitals. Patients who received VCM intravenously with measured trough and another point (e.g., peak) concentrations within the November 2011 to March 2019 period were enrolled. We extracted the factors that affect VCM concentration and constructed a decision tree model using a classification and regression tree algorithm. Of the 1380 patients, 822 were included. Training data were split up to four times and included 24 subgroups. The average corrected VCM daily doses ranged 17.6-59.4 mg/kg. Estimated glomerular filtration rate, age, and body mass index were selected as predictive variables that affected the recommended daily dose. In the validation data, our model had slightly higher proportions of AUC of 400-600 mg⋅h/L than other nomograms. However, our model was based only on limited patients. Thus, further clinical studies are needed to develop a general-purpose model in the future. We successfully constructed a model that recommends VCM maintenance daily doses with AUC of 400-600 mg⋅h/L for each combination of independent variables. Our model has the potential for application as a simple decision-making tool for medical staff.

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“…International clinical practice guidelines and position statements suggest that the therapeutic drug monitoring of vancomycin should be guided by area under the curve (AUC) values [1][2][3]. Tis is because AUC-guided dosing is associated with less treatment failure and improved safety compared to trough-guided monitoring in patients with methicillin-resistant Staphylococcus aureus infection [4].…”

Section: Introductionmentioning

confidence: 99%

Discrepancies Between Bayesian Vancomycin Models Can Affect Clinical Decisions in the Critically Ill

Patanwala

Spremo

Jeon

et al. 2022

Critical Care Research and Practice

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Purpose. To assess the agreement in 24-hour area under the curve (AUC24) value estimates between commonly used vancomycin population pharmacokinetic models in the critically ill. Materials and Methods. Adults admitted to intensive care who received intravenous vancomycin and had a serum vancomycin concentration available were included. AUC24 values were determined using Tucuxi (revision cd7bd7a8) for dosing intervals with a vancomycin concentration using three models (Goti 2018, Colin 2019, and Thomson 2009) previously evaluated in the critically ill. AUC24 values were categorized as subtherapeutic (<400 mg·h/L), therapeutic (400–600 mg·h/L), or toxic (>600 mg·h/L), assuming a minimum inhibitory concentration of 1 mg/L. AUC24 value categorization was compared across the three models and reported as percent agreement. Results. Overall, 466 AUC24 values were estimated in 188 patients. Overall, 52%, 42%, and 47% of the AUC24 values were therapeutic for the Goti, Colin, and Thomson models, respectively. The agreement of AUC24 values between all three models was 48% (223/466), Goti-Colin 59% (193/466), Goti-Thomson 68% (318/466), and Colin-Thomson 67% (314/466). Conclusion. In critically ill patients, vancomycin AUC24 values obtained from different pharmacokinetic models are often discordant, potentially contributing to differences in dosing decisions. This highlights the importance of selecting the optimal model.

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Clinical Practice Guidelines for Therapeutic Drug Monitoring of Vancomycin in the Framework of Model-Informed Precision Dosing: A Consensus Review by the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring

Cited by 65 publications

References 211 publications

Evaluation of vancomycin pharmacokinetics in patients with augmented renal clearances: A randomized clinical trial

Evaluation of vancomycin pharmacokinetics in patients with augmented renal clearances: A randomized clinical trial

Machine Learning-Based Model for Estimating Vancomycin Maintenance Dose to Target the Area under the Concentration Curve of 400–600 mg·h/L in Japanese Patients

Discrepancies Between Bayesian Vancomycin Models Can Affect Clinical Decisions in the Critically Ill

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