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Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis

In a pooled population analysis, we investigated the pharmacokinetics of i.v. anidulafungin in four studies across a full range of adult and pediatric ages in patients with confirmed, suspected, or at high risk of invasive candidiasis (IC). Relationships between anidulafungin exposure and key effica...

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Autores principales: Xie, Rujia, McFadyen, Lynn, Raber, Susan, Swanson, Robert, Tawadrous, Margaret, Leister‐Tebbe, Heidi, Cohen‐Wolkowiez, Michael, Benjamin, Daniel K., Liu, Ping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485140/
https://www.ncbi.nlm.nih.gov/pubmed/32189334
http://dx.doi.org/10.1002/cpt.1831
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author Xie, Rujia
McFadyen, Lynn
Raber, Susan
Swanson, Robert
Tawadrous, Margaret
Leister‐Tebbe, Heidi
Cohen‐Wolkowiez, Michael
Benjamin, Daniel K.
Liu, Ping
author_facet Xie, Rujia
McFadyen, Lynn
Raber, Susan
Swanson, Robert
Tawadrous, Margaret
Leister‐Tebbe, Heidi
Cohen‐Wolkowiez, Michael
Benjamin, Daniel K.
Liu, Ping
author_sort Xie, Rujia
collection PubMed
description In a pooled population analysis, we investigated the pharmacokinetics of i.v. anidulafungin in four studies across a full range of adult and pediatric ages in patients with confirmed, suspected, or at high risk of invasive candidiasis (IC). Relationships between anidulafungin exposure and key efficacy end points (global response of success and all‐cause mortality) and safety end points (all‐cause hepatic or gastrointestinal adverse events) in all patients and separately in pediatric patients and the appropriate dosing regimen for IC treatment in pediatric patients were evaluated. Pediatric patients received a 3.0 mg/kg (maximum 200 mg) i.v. loading dose and 1.5 mg/kg (maximum 100 mg) daily thereafter. Adults received a 200 mg i.v. loading dose and 100 mg daily thereafter. Estimated systemic anidulafungin exposures were similar across age groups (neonates to adults) at the weight‐based doses studied in pediatric patients. No clear associations were identified between anidulafungin exposure and efficacy or safety end points.
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spelling pubmed-74851402020-09-18 Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis Xie, Rujia McFadyen, Lynn Raber, Susan Swanson, Robert Tawadrous, Margaret Leister‐Tebbe, Heidi Cohen‐Wolkowiez, Michael Benjamin, Daniel K. Liu, Ping Clin Pharmacol Ther Research In a pooled population analysis, we investigated the pharmacokinetics of i.v. anidulafungin in four studies across a full range of adult and pediatric ages in patients with confirmed, suspected, or at high risk of invasive candidiasis (IC). Relationships between anidulafungin exposure and key efficacy end points (global response of success and all‐cause mortality) and safety end points (all‐cause hepatic or gastrointestinal adverse events) in all patients and separately in pediatric patients and the appropriate dosing regimen for IC treatment in pediatric patients were evaluated. Pediatric patients received a 3.0 mg/kg (maximum 200 mg) i.v. loading dose and 1.5 mg/kg (maximum 100 mg) daily thereafter. Adults received a 200 mg i.v. loading dose and 100 mg daily thereafter. Estimated systemic anidulafungin exposures were similar across age groups (neonates to adults) at the weight‐based doses studied in pediatric patients. No clear associations were identified between anidulafungin exposure and efficacy or safety end points. John Wiley and Sons Inc. 2020-04-19 2020-08 /pmc/articles/PMC7485140/ /pubmed/32189334 http://dx.doi.org/10.1002/cpt.1831 Text en © 2020 Pfizer Pte Ltd. Clinical Pharmacology & Therapeutics Published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
Xie, Rujia
McFadyen, Lynn
Raber, Susan
Swanson, Robert
Tawadrous, Margaret
Leister‐Tebbe, Heidi
Cohen‐Wolkowiez, Michael
Benjamin, Daniel K.
Liu, Ping
Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis
title Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis
title_full Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis
title_fullStr Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis
title_full_unstemmed Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis
title_short Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis
title_sort population analysis of anidulafungin in infants to older adults with confirmed or suspected invasive candidiasis
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485140/
https://www.ncbi.nlm.nih.gov/pubmed/32189334
http://dx.doi.org/10.1002/cpt.1831
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