Assessment of Hepatic Safety of Ulipristal Acetate in Korean Women with Uterine Fibroids: A Real-World Study Using Biochemical Markers

Abstract

Background/Objectives: Ulipristal acetate (UPA) is a selective progesterone receptor modulator approved for the treatment of uterine fibroids, but concerns have arisen regarding its potential for severe hepatotoxicity, particularly following regulatory warnings in Europe and Korea. The real-world risk of UPA-induced liver injury in Korean women remains largely unknown. To evaluate the hepatic safety of UPA among Korean women with uterine fibroids using large-scale, population-based healthcare claims and health screening data. Methods: A retrospective, propensity score-matched cohort study was conducted using the Korean National Health Insurance Service database. Women diagnosed with uterine fibroids who received UPA between 2013 and 2016 (n = 12,166) were compared to matched controls (n = 36,498) who did not receive UPA. Primary outcomes included changes in liver enzymes (AST, ALT, γ-GTP) and Fatty Liver Index (FLI) before and after UPA use. Results: UPA users showed small but statistically significant increases in ALT, γ-GTP, and FLI compared to pre-treatment values, though all values remained within normal reference ranges. Odds of elevated FLI (≥60) and γ-GTP (≥40 IU/L) were modestly increased in the UPA group, but no cases of severe hepatotoxicity or liver failure occurred. Conclusions: UPA use in Korean women was associated with mild, subclinical elevations in liver enzymes and fatty liver index, but not with clinically significant hepatotoxicity. These findings support vigilant hepatic monitoring during UPA therapy, while contextualizing its risk as low in this population.