4.2 Article

Risk assessment of micafungin-induced liver injury using spontaneous reporting system data and electronic medical records

Journal

JOURNAL OF INFECTION AND CHEMOTHERAPY
Volume 28, Issue 5, Pages 690-695

Publisher

ELSEVIER
DOI: 10.1016/j.jiac.2022.01.024

Keywords

Antifungal drugs; Drug-induced liver injury; Japanese adverse drug event report; Micafungin; Albumin-bilirubin score

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This study made important progress in elucidating the feasibility and relevant factors of micafungin-induced liver injury by using the JADER database for signal detection associated with antifungal-induced liver injuries and medical records for risk assessment.
Introduction: There is limited information regarding antifungal-induced liver injuries, which have high mortality rates. Therefore, we used the Japanese Adverse Drug Event Report (JADER) database for signal detection associated with antifungal-induced liver injuries and medical records for risk assessment.& nbsp;Methods: Reports of antifungal-induced liver injuries from JADER data were analyzed to calculate the reporting odds ratio (ROR) and 95% confidence interval (CI). A medical record-based study involving 109 adult patients treated with micafungin shows liver injury as the primary outcome in patients treated with micafungin. The albumin-bilirubin (ALBI) score was calculated based on albumin and total bilirubin levels. We selected five explanatory factors for multivariable logistic regression: alanine aminotransferase >= 20 IU/L, alkaline phosphatase >= 372 IU/L, aspartate aminotransferase >= 25 IU/L, ALBI score >=-1.290, and age >= 65 years.& nbsp;Results: Signal detection for micafungin was observed in both, hepatocellular and cholestatic injuries, as per data from JADER. Univariate analyses performed on medical records suggest that alanine aminotransferase (p = 0.008), aspartate aminotransferase (p = 0.036), alkaline phosphatase (p = 0.045), and ALBI score (p = 0.028) may be factors associated with micafungin-induced liver injury. Based on multivariable logistic regression, the adjusted odds ratio for micafungin-induced liver injury in patients with ALBI score >=-1.290 was 2.78 (95% CI: 1.014-7.605, p = 0.047), suggesting that low hepatic functional reserve could be a risk factor for micafungininduced liver injury.& nbsp;Conclusions: Careful monitoring of liver function may be necessary for micafungin administration in patients with low hepatic functional reserve.

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