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@article{1367263,
author = {Martin, Judith m. and MaciasandPara, Mercedes and Múdry, Peter and Conte, Umberto and Yan, Jean L. and Ping, Liu and Capparella, Rita and Aram, Jalal A.},
article_location = {Philadelphia},
article_number = {1},
doi = {http://dx.doi.org/10.1097/INF.0000000000001339},
keywords = {aspergillosis; candidiasis; exposure-response; pediatric; voriconazole},
language = {eng},
issn = {0891-3668},
journal = {Pediatric Infectious Disease Journal},
title = {Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients with Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis},
url = {http://dx.doi.org/10.1097/INF.0000000000001339},
volume = {36},
year = {2017}
}
TY - JOUR
ID - 1367263
AU - Martin, Judith m. - Macias-Para, Mercedes - Múdry, Peter - Conte, Umberto - Yan, Jean L. - Ping, Liu - Capparella, Rita - Aram, Jalal A.
PY - 2017
TI - Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients with Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis
JF - Pediatric Infectious Disease Journal
VL - 36
IS - 1
SP - "e1"-"e13"
EP - "e1"-"e13"
PB - Lippincott Williams & Wilkins
SN - 08913668
KW - aspergillosis
KW - candidiasis
KW - exposure-response
KW - pediatric
KW - voriconazole
UR - http://dx.doi.org/10.1097/INF.0000000000001339
L2 - http://dx.doi.org/10.1097/INF.0000000000001339
N2 - Data on safety and efficacy of voriconazole for invasive aspergillosis (IA) and invasive candidiasis/esophageal candidiasis (IC/EC) in pediatric patients are limited. Methods: Patients aged 2-<18 years with IA and IC/EC were enrolled in 2 prospective open-label, non-comparative studies of voriconazole. Patients followed dosing regimens based on age, weight and indication, with adjustments permitted. Treatment duration was 6-12 weeks for IA patients, 14 days after last positive Candida culture for IC patients and 7 days after signs/symptoms resolution for EC patients. Primary analysis for both the studies was safety and tolerability of voriconazole. Secondary end points included global response success at week 6 and end of treatment (EOT), all-causality mortality and time to death. Voriconazole exposure-response relationship was explored. Results: Of 53 voriconazole-treated pediatric patients (31 IA; 22 IC/EC), 14 had proven/probable IA, 7 had confirmed IC and 10 had confirmed EC. Treatment-related hepatic and visual adverse events, respectively, were reported in 22.6% and 16.1% of IA patients, and 22.7% and 27.3% of IC/EC patients. All-causality mortality in IA patients was 14.3% at week 6; no deaths were attributed to voriconazole. No deaths were reported for IC/EC patients. Global response success rate was 64.3% (week 6 and EOT) in IA patients and 76.5% (EOT) in IC/EC patients. There was no association between voriconazole exposure and efficacy; however, a slight positive association between voriconazole exposure and hepatic adverse events was established. Conclusions: Safety and efficacy outcomes in pediatric patients with IA and IC/EC were consistent with previous findings in adult patients.
ER -
MARTIN, Judith m., Mercedes MACIAS-PARA, Peter MÚDRY, Umberto CONTE, Jean L. YAN, Liu PING, Rita CAPPARELLA and Jalal A. ARAM. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients with Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. \textit{Pediatric Infectious Disease Journal}. Philadelphia: Lippincott Williams \&{} Wilkins, 2017, vol.~36, No~1, p.~''e1''-''e13'', 13 pp. ISSN~0891-3668. Available from: https://dx.doi.org/10.1097/INF.0000000000001339.
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