Clinical pharmacokinetic and pharmacodynamic analysis of daptomycin and the necessity of high-dose regimen in Japanese adult patients

Urakami, Toshiharu; Hamada, Yohei; Oka, Yoshikazu; Okinaka, Tomohide; Yamakuchi, Hiroki; Magarifuchi, Hiroki; Aoki, Yosuke

doi:10.1016/j.jiac.2019.01.011

Cited by 17 publications

(14 citation statements)

References 19 publications

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“…In the validation group, 21.3% of patients did not achieve the AUC 24h target on the first TDM occasion after initial dosing, and 31.9% had C min values above the safety target. Urakami et al reported a low rate of efficacy target attainment (40%) in patients who received 6 mg/kg [31]. In another prospective TDM study in patients who received daptomycin for bacteremia, 9.5% of individuals showed C min > 24.3 mg/L.…”

Section: Discussionmentioning

confidence: 97%

Implementation and Comparison of Two Pharmacometric Tools for Model-Based Therapeutic Drug Monitoring and Precision Dosing of Daptomycin

et al. 2022

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Daptomycin is a candidate for therapeutic drug monitoring (TDM). The objectives of this work were to implement and compare two pharmacometric tools for daptomycin TDM and precision dosing. A nonparametric population PK model developed from patients with bone and joint infection was implemented into the BestDose software. A published parametric model was imported into Tucuxi. We compared the performance of the two models in a validation dataset based on mean error (ME) and mean absolute percent error (MAPE) of individual predictions, estimated exposure and predicted doses necessary to achieve daptomycin efficacy and safety PK/PD targets. The BestDose model described the data very well in the learning dataset. In the validation dataset (94 patients, 264 concentrations), 21.3% of patients were underexposed (AUC24h < 666 mg.h/L) and 31.9% of patients were overexposed (Cmin > 24.3 mg/L) on the first TDM occasion. The BestDose model performed slightly better than the model in Tucuxi (ME = −0.13 ± 5.16 vs. −1.90 ± 6.99 mg/L, p < 0.001), but overall results were in agreement between the two models. A significant proportion of patients exhibited underexposure or overexposure to daptomycin after the initial dosage, which supports TDM. The two models may be useful for model-informed precision dosing.

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Section: Discussionmentioning

confidence: 97%

Implementation and Comparison of Two Pharmacometric Tools for Model-Based Therapeutic Drug Monitoring and Precision Dosing of Daptomycin

et al. 2022

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“…Although the approved dose regimen for DAP is up to 6 mg/kg daily, Urakami et al pointed out the necessity of a high-dose regimen of above 8 mg/kg to ensure its effectiveness in patients with normal renal function. 18) Thus, TDM for DAP is necessary and useful for maximizing its efficacy and safety.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Daptomycin-Induced Cellular Membrane Injury in Skeletal Muscle

Yamada

Ishikawa

Ishiguro

et al. 2020

Biological & Pharmaceutical Bulletin

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Daptomycin, a cyclic lipopeptide antibiotic, has bactericidal activity against Gram-positive organisms and is especially effective against methicillin-resistant Staphylococcus aureus. Although daptomycin causes unique adverse drug reactions such as elevation of creatine phosphokinase or rhabdomyolysis, the detailed mechanisms underlying these adverse drug reactions in skeletal muscle are unclear. This study aimed to elucidate whether daptomycin causes direct skeletal muscle cell toxicity and investigate the relationship between daptomycin exposure and musculoskeletal toxicity. First, we evaluated the relationship between daptomycin exposure and skeletal muscle toxicity. Of the 38 patients who received daptomycin intravenously, an elevation in creatine phosphokinase levels was observed in five. The median plasma trough concentration of daptomycin in patients with elevated creatine phosphokinase levels was significantly higher than that in patients whose creatine phosphokinase levels were within the normal range, suggesting that increased exposure to daptomycin is related to elevation in creatine phosphokinase levels. In an in vitro study using human rhabdomyosarcoma cells, daptomycin reduced cell viability and increased membrane damage. These effects were more marked under hypoxic conditions. A necroptotic pathway seemed to be involved because phosphorylated mixed lineage kinase domain-like protein expression was enhanced following daptomycin exposure, which was significantly enhanced under hypoxic conditions. These findings indicate that daptomycin elicits cytotoxic effects against skeletal muscle cells via the necroptotic pathway, and the extent of toxicity is enhanced under hypoxic conditions.

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“…Urakami et al [40] used Monte Carlo simulation and TDM to investigate the best way to manage DAP based on PK/PD parameters. Serum concentrations of DAP in 16 MRSAinfected patients were measured by the HPLC-UV system.…”

Section: Report On the Measurement Of Blood Levels Of Daptomycin In Japanmentioning

confidence: 99%

“…The analysis column was a TSK gel Octyl −80 Ts, 5 μ, 250 × 4.6 mm (TOSOH, Tokyo, Japan), UV wavelength was 214 nm, mobile phase was 40 mM phosphate ammonium buffer (pH 4.5)/ acetonitrile = 60:40 v/v. All used solvents were HPLC grade [40].…”

Section: Report On the Measurement Of Blood Levels Of Daptomycin In Japanmentioning

confidence: 99%

Potential Clinical Benefits of TDM of Antimicrobials in Japan

Ebihara¹,

Hamada²,

Maruyama³

et al. 2022

Preprint

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Under the Japanese health insurance system, medicines undergoing therapeutic drug monitoring (TDM) can be billed for medical fees if they meet the specified requirements. In Japan, TDM of vancomycin, teicoplanin, aminoglycosides, and voriconazole, which are used for the treatment of infectious diseases, is common practice. This means the levels of antimicrobial agents are measured in-house using chromatography. This review describes personalized medicine based on the use of chromatography as a result of the current situation in Japan.

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Clinical pharmacokinetic and pharmacodynamic analysis of daptomycin and the necessity of high-dose regimen in Japanese adult patients

Cited by 17 publications

References 19 publications

Implementation and Comparison of Two Pharmacometric Tools for Model-Based Therapeutic Drug Monitoring and Precision Dosing of Daptomycin

Implementation and Comparison of Two Pharmacometric Tools for Model-Based Therapeutic Drug Monitoring and Precision Dosing of Daptomycin

Evaluation of Daptomycin-Induced Cellular Membrane Injury in Skeletal Muscle

Potential Clinical Benefits of TDM of Antimicrobials in Japan

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