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ADVERSE EVENTS

Investigation of the Potential Relationships Between Plasma Voriconazole Concentrations and Visual Adverse Events or Liver Function Test Abnormalities

Keith Tan, PhD, Nigel Brayshaw, MSc, Konrad Tomaszewski, PhD, Peter Troke, PhD and Nolan Wood, PhD

From Clinical Pharmacology (Dr Tan, Dr Wood), Development Operations (Mr Brayshaw), Regulatory Affairs (Dr Tomaszewski), and Clinical R&D (Dr Troke), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom.

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 µg/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.

Key Words: Voriconazole • visual adverse event • liver function test • plasma concentration

Address for reprints: Keith Tan, Clinical R&D (IPC 096), Pfizer Global Research and Development, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.




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