Use of ulipristal acetate and risk of liver disease: a nationwide cohort study.

Context Large-scale clinical trials on the hepatotoxicity of ulipristal acetate (UPA) are lacking. Objective To determine the incidence of liver disease with UPA versus gonadotropin-releasing hormone (GnRH) agonists. Design Retrospective cohort study. Setting National health insurance data in South Korea. Patients or other participants Women with uterine fibroids from the Korean Health Insurance Data 2010-2018. Intervention(s) Women with uterine fibroids were divided into two treatment groups: the UPA (5 mg/day) and GnRH agonist groups. Main outcome measure(s) Presence or absence of severe liver disease, mild liver disease, and liver transplantation. Results Among the patients with uterine fibroids,17,207 patients were treated with GnRH agonists and 20,926 patients with UPA. After 1:1 propensity score matching for each group, there were 11,445 individuals. Neither group had a liver transplantation case. In the conditional logistic regression analysis, the incidences of total liver diseases (relative risk [RR] 1.111, 95% confidence interval [CI] 1.015-1.216) and mild liver diseases (RR 1.094, 95% CI 1-1.196) were higher in the UPA group than in the GnRH agonist group, but those of severe liver diseases (RR 0.07, 95% CI 0.001-4.412) and toxic liver disease (RR 1.256, 95% CI 0.845-1.867) did not differ between the groups. Conclusions The incidences of severe liver disease, hepatic failure, and toxic liver disease were not different between the UPA and GnRH agonist groups. However, the incidence of mild liver disease was higher in the UPA group than in the GnRH agonist group. The incidence of hepatic damage with UPA was very low.