| アブストラクト | BACKGROUND: Drug-induced liver injury (DILI) is a known significant adverse effect of pirfenidone and nintedanib, essential antifibrotic agents for idiopathic pulmonary fibrosis (IPF). However, real-world evidence on the risk profiles is limited. We aimed to describe the clinical profiles and identify risk factors for antifibrotic DILI in real-world practice to inform risk mitigation strategies. METHODS: A retrospective case-control study was conducted among patients receiving pirfenidone at our tertiary hospital between October 2011 and December 2022 (approval No. ES-2024-K064-01). Hepatic safety signals were also evaluated through disproportionality analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) using reporting odds ratios (RORs). RESULTS: For pirfenidone, among 3,199 treated patients, 63 (3.18%) developed DILI, typically within two weeks of therapy initiation. Significant risk factors included body mass index (BMI) </=23.9 kg/m(2) [odds ratio (OR) =7.32, P<0.001], >/=4 comorbidities (OR =7.18, P<0.001), pre-existing liver disease (OR =3.31, P=0.004), and alcohol consumption (OR =4.52, P=0.002). FAERS analysis recorded 904 hepatic adverse event (AE) reports, with 338 positive signals, most involving men aged 65-74 years and occurring within 30 days of initiation (6.89%). For nintedanib, 3.2% of exposed patients experienced DILI. FAERS analysis documented 2,114 hepatic AE reports, with 1,634 positive signals, predominantly in men aged 65-74 years, with 30.29% occurring within 30 days of initiation. CONCLUSIONS: Both pirfenidone and nintedanib carry notable hepatotoxicity risks. Close liver function monitoring is advised during early treatment, especially in patients with low BMI, multiple comorbidities, pre-existing liver disease, or alcohol consumption. |
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| 投稿者 | Ou, Xinyi; Wu, Yaozhou; Cheng, Qian; Yin, Weiwei; Rong, Chunyu; He, Suzhen; Wei, Li; Yu, Pengjiu |
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