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Effectiveness, Tolerability, and Safety of Different Amphotericin B Formulations in Invasive Fungal Infections: A Multicenter, Retrospective, Observational Study.
Cavassin, Francelise Bridi; Magri, Marcello Mihailenko Chaves; Vidal, Jose Ernesto; de Moraes Costa Carlesse, Fabianne Altruda; Falci, Diego Rodrigues; Baú-Carneiro, João Luís; Breda, Giovanni Luís; de Araújo Motta, Fábio; de Miranda Godoy, Cássia Silva; de Bastos Ascenço Soares, Renata; De Oliveira, Carla Sakuma; Mendes, Ana Verena Almeida; Morales, Hugo Paz; Montes, Patrícia Silva; Taborda, Mariane; Rego, Caroline Martins; Félix, Maíra Araujo; Katopodis, Paula Pacheco; da Silva do Ó, Julia Raquel; Abrão, Mirela Pereira Lima; Pereira, Talita Teles Teixeira; Queiroz-Telles, Flávio.
Afiliación
  • Cavassin FB; Universidade Federal do Paraná (UFPR), Curitiba, Brazil. Electronic address: francelise.cavassin@ufpr.br.
  • Magri MMC; Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FAMUSP), São Paulo, Brazil.
  • Vidal JE; Instituto de Infectologia Emílio Ribas (IIER), São Paulo, Brazil.
  • de Moraes Costa Carlesse FA; Universidade Federal de São Paulo/ Escola Paulista de Medicina (UNIFESP/EPM), São Paulo, Brazil.
  • Falci DR; Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.
  • Baú-Carneiro JL; Faculdades Pequeno Príncipe (FPP), Curitiba, Brazil.
  • Breda GL; Hospital de Clínicas da Universidade Federal do Paraná (HC/UFPR), Curitiba, Brazil.
  • de Araújo Motta F; Hospital Pequeno Príncipe (HPP), Curitiba, Brazil.
  • de Miranda Godoy CS; Hospital de Doenças Tropicais Dr. Anuar Auad (HDT), Goiânia, Brazil.
  • de Bastos Ascenço Soares R; Hospital Estadual de Doenças Tropicais Dr. Anuar Auad (HDT), Goiânia, Brazil.
  • De Oliveira CS; Hospital Universitário do Oeste do Paraná (HUOP), Cascavel, Brazil.
  • Mendes AVA; Hospital São Rafael (HSR), Salvador, Brazil.
  • Morales HP; Hospital Erasto Gaertner (HEG), Curitiba, Brazil.
  • Montes PS; Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FAMUSP), São Paulo, Brazil.
  • Taborda M; Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FAMUSP), São Paulo, Brazil.
  • Rego CM; Instituto de Infectologia Emílio Ribas (IIER), São Paulo, Brazil.
  • Félix MA; Instituto de Infectologia Emílio Ribas (IIER), São Paulo, Brazil.
  • Katopodis PP; Pontifícia Universidade Católica de Goiás, Goiânia, Brazil.
  • da Silva do Ó JR; Pontifícia Universidade Católica de Goiás, Goiânia, Brazil.
  • Abrão MPL; Universidade Federal de Goiás, Goiânia, Brazil.
  • Pereira TTT; Hospital São Rafael (HSR), Salvador, Brazil.
  • Queiroz-Telles F; Universidade Federal do Paraná (UFPR), Hospital de Clínicas da Universidade Federal do Paraná (HC/UFPR), Curitiba, Brazil.
Clin Ther ; 46(4): 322-337, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38403508
ABSTRACT

PURPOSE:

Data on the real-life use of amphotericin B lipid complex (ABLC) compared with other available formulations are limited. This study aimed to evaluate the effectiveness, tolerability, and safety of different amphotericin B (AMB) intravenously administered in the context of hospital practice for the treatment of invasive fungal infections (IFI) and to provide new insights into the profile of ABLC.

METHODS:

This is a multicenter, retrospective, observational study conducted at 10 tertiary Brazilian hospitals. Patients first exposed to any formulation of AMB for treating endemic and opportunistic IFI who had received at least 2 intravenous doses were screened. Retrospective data (from January 2014 to December 2019) were extracted from the patients' medical records. Clinical parameters were examined pre- and post-treatment to determine effectiveness; acute infusion-related side effects (IRSE) and drug interruption to determine tolerability; and adverse events, toxicity, and treatment interruption were stated to analyze safety.

FINDINGS:

Overall, 1879 medical records of patients were identified. The median (interquartile rate) duration of treatment was 14 (7-21) days. The overall success rate (95% confidence interval [CI]) was 65% (95% CI 60-65). ABLC proved to be effective among AMB formulations with 59% (95% CI 55.6-62.5) within complete response. This was significantly higher in patients who received the drug for a longer period, ≥4 weeks compared to <1 week treatment (P < 0.001). IRSE was observed in 446 (23.7%) patients. Eight cases (1.4%) of severe IRSE in pediatrics and 14 (1.1%) in adults resulted in treatment discontinuation. Regarding safety, 637 (33.9%) patients presented some alteration in creatinine levels during AMB exposure, and 89 (4.74%) had to interrupt or discontinue the drug within the first 14 days of therapy because of renal dysfunction. Overall mortality was 34%. IMPLICATIONS ABLC is an effective formulation for the treatment of invasive fungal infections, with few adverse events leading to drug discontinuation or lethal outcomes. Furthermore, this real-life study confirmed the comparative safety of AMB lipid formulations versus AMB deoxycholate.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anfotericina B / Infecciones Fúngicas Invasoras / Antifúngicos Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do sul / Brasil Idioma: En Revista: Clin Ther Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anfotericina B / Infecciones Fúngicas Invasoras / Antifúngicos Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do sul / Brasil Idioma: En Revista: Clin Ther Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos