Use of Ulipristal Acetate and Risk of Liver Disease: A Nationwide Cohort Study.

Abstract

Large-scale clinical trials on the hepatotoxicity of ulipristal acetate (UPA) are lacking. This work aimed to determine the incidence of liver disease with UPA vs gonadotropin-releasing hormone (GnRH) agonists. A retrospective cohort study was conducted in South Korea of women with uterine fibroids from the Korean Health Insurance Data 2010 to 2018. Women with uterine fibroids were divided into 2 treatment groups: the UPA (5 mg/day) and GnRH agonist groups. Main outcome measures included the presence or absence of severe liver disease, mild liver disease, and liver transplantation. 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 incidence of total liver diseases (relative risk [RR] 1.111; 95% CI, 1.015-1.216) and mild liver diseases (RR 1.094; 95% CI, 1-1.196) was higher in the UPA group than in the GnRH agonist group, but that 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. The incidence of severe liver disease, hepatic failure, and toxic liver disease was 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.