Investigation of the potential relationships between plasma voriconazole concentrations and visual adverse events or liver function test abnormalities

被引:223
作者
Tan, K
Brayshaw, N
Tomaszweski, K
Troke, P
Wood, N
机构
[1] Pfizer Ltd, Global Res & Dev, Clin R&D, Sandwich CT13 9NJ, Kent, England
[2] Pfizer Ltd, Global Res & Dev, Regulatory Affairs, Sandwich CT13 9NJ, Kent, England
[3] Pfizer Ltd, Global Res & Dev, Dev Operat, Sandwich CT13 9NJ, Kent, England
[4] Pfizer Ltd, Global Res & Dev, Clin Pharmacol, Sandwich CT13 9NJ, Kent, England
关键词
voriconazole; visual adverse event; liver function test; plasma concentration;
D O I
10.1177/0091270005283837
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
This study investigated the relationship between plasma voriconazole concentrations (pVC) and risk of visual adverse events (VAEs) or liver function test (LFT) abnormalities using longitudinal logistic regression. Seven-day mean pVC were calculated from 2925 plasma samples (1053 patients); in each 7-day period, the presence or absence of VAEs/abnormal LFTs was analyzed as a binary outcome variable. There was a relationship between pVC and risk of VAE (P =.011) and a weaker, but statistically significant, association with risk of aspartate transaminase (AST), alkaline phosphatase (ALP), or bilirubin but not alanine transaminase (ALT) abnormalities, The odds ratios of LFT abnormalities per 1 mu g/mL pVC increase ranged from 1.07 to 1.17. Maximum weekly occurrences were 10%, 8% 5%. and 14% for AST ALT ALP and bilirubin abnormalities. respectively Receiver-operating characteristic curve analysis indicates that individual pVC cannot be used to predict Subsequent LFT abnormalities.
引用
收藏
页码:235 / 243
页数:9
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