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Effectiveness and safety of the simulation-based first-dose design of voriconazole.
Umemura, Takumi; Kakizaki, Hiromi; Mutoh, Yoshikazu; Mizuno, Takahito; Ito, Yuki; Hioki, Tatsuya; Kato, Hideo; Hagihara, Mao; Yamada, Tetsuya; Ikeda, Yoshiaki; Mikamo, Hiroshige; Ichihara, Toshihiko; Hamada, Yukihiro.
Afiliación
  • Umemura T; Department of Pharmacy, Tosei General Hospital, Seto, Aichi, Japan; Department of Clinical Infectious Diseases, Tosei General Hospital, Seto, Aichi, Japan; Department of Clinical Infectious Diseases, Aichi Medical University, Nagakute, Aichi, Japan; College of Pharmacy, Kinjo Gakuin University, Nago
  • Kakizaki H; Department of Pharmacy, Tosei General Hospital, Seto, Aichi, Japan.
  • Mutoh Y; Department of Clinical Infectious Diseases, Tosei General Hospital, Seto, Aichi, Japan.
  • Mizuno T; Department of Pharmacy, Tosei General Hospital, Seto, Aichi, Japan.
  • Ito Y; Department of Pharmacy, Tosei General Hospital, Seto, Aichi, Japan.
  • Hioki T; Department of Clinical Infectious Diseases, Tosei General Hospital, Seto, Aichi, Japan.
  • Kato H; Department of Clinical Infectious Diseases, Aichi Medical University, Nagakute, Aichi, Japan; Department of Pharmacy, Mie University Hospital, Tsu, Mie, Japan.
  • Hagihara M; Department of Clinical Infectious Diseases, Aichi Medical University, Nagakute, Aichi, Japan.
  • Yamada T; Department of Pharmacy, Tosei General Hospital, Seto, Aichi, Japan.
  • Ikeda Y; College of Pharmacy, Kinjo Gakuin University, Nagoya, Aichi, Japan.
  • Mikamo H; Department of Clinical Infectious Diseases, Aichi Medical University, Nagakute, Aichi, Japan.
  • Ichihara T; Department of Pharmacy, Tosei General Hospital, Seto, Aichi, Japan.
  • Hamada Y; Department of Pharmacy, Kochi Medical School Hospital, Nankoku, Kochi, Japan.
J Infect Chemother ; 2024 Jun 27.
Article en En | MEDLINE | ID: mdl-38944383
ABSTRACT

BACKGROUND:

We investigated whether the initial voriconazole (VRCZ) dosing design, as determined using simulation software with a population pharmacokinetic model of Japanese patients, impacts the effectiveness and safety when compared with VRCZ initiation according to the package insert.

METHODS:

In this single-center retrospective observational study, we employed records from Tosei General Hospital (a 633-bed hospital), dated April 2017 to September 2023. Eligible patients were divided into the software-based simulation group, comprising patients administered initial VRCZ dosage adjustment by pharmacists using software-based simulation, and the standard therapy group, whose dosage was administered by a physician following the package insert recommendations without simulation. The primary objective of this study was to determine the efficacy of VRCZ first-dose design in reducing the incidence of hepatotoxicity and visual symptoms.

RESULTS:

The median ages of enrolled participants (n = 93) were 75 (68-79) and 72 (65-78) years in the software-based simulation and standard therapy groups, respectively. Regardless of formulation, initial trough concentrations were lower in the VRCZ software-based first dosage adjustment group and higher rate within the appropriate range (1-4 µg/mL). The incidence of all-grade hepatotoxicity or visual symptoms was significantly lower in the software-based simulation group. The log-rank test revealed a significant impact on the occurrence of ≥grade 2 hepatotoxicity in the software-based first dosage adjustment group compared to that in the standard therapy group.

CONCLUSIONS:

The initial VRCZ dosing design using simulation software improved the achievement of appropriate initial trough concentrations and resulted in fewer occurrences of hepatotoxicity (≥grade 2) when compared with the standard therapy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Infect Chemother Asunto de la revista: MICROBIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Infect Chemother Asunto de la revista: MICROBIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos