Liver function, tolerability and satisfaction during treatment with ulipristal acetate in women with fibroids: a single center experience

Abstract

The aim of the study was to evaluate liver function in women treated with ulipristal acetate (UPA) and to assess the tolerability and satisfaction during treatment. This Cross-sectional study included women with symptomatic uterine fibroids subjected to one or more 3-month treatment courses of 5 mg UPA daily. Following European Medical Agency’s prescriptions, women were asked about symptoms potentially related to liver damage and had blood tests done, to assess serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Data on side effects, tolerability and satisfaction with the therapy were obtained during a phone interview. A total of 162 women completed the study with a mean treatment duration of 1.8 ± 0.9 cycles. No increased AST and ALT serum levels were detected and no woman reported symptoms suggestive of liver injury. The majority of women reported improvement of fibroids-related symptoms and a high degree of satisfaction with treatment. More than half of women had side effects, in most cases not as severe as to discontinue therapy. Ulipristal acetate did not worsen liver function or cause severe organ injury and showed high tolerability and satisfaction profiles. Therefore, we believe that it can still be considered a valuable option in the treatment of uterine fibroids.

摘要

本研究的目的是评估醋酸乌利司他（UPA）治疗期间妇女的肝功能并评估治疗期间的耐受性和满意度。这项横断面研究包括有症状的子宫肌瘤妇女, 她们接受一个或多个为期3个月的每天5mg UPA治疗疗程。根据欧洲医疗机构的处方, 妇女被问及可能与肝损伤有关的症状, 并进行血液测试, 以评估血清天冬氨酸转氨酶（AST）和丙氨酸转氨酶（ALT）水平。在电话采访中获得了关于副作用、耐受性和治疗满意度的数据。共有162名妇女完成了这项研究, 平均治疗时间为1.8±0.9个周期, 没有检测到血清AST和ALT水平升高, 也没有女性报告有肝损伤的症状。大多数妇女报告了纤维瘤相关症状改善和对治疗的高度满意。超过一半的妇女有副作用, 在大多数情况下没有到停止治疗那么严重。醋酸乌利司他没有引起肝功能恶化或引起严重的器官损伤, 显示出高耐受性和满意度。因此, 我们认为在子宫肌瘤的治疗中仍然可以将其视为有价值的选择。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• Liver function
• tolerability
• satisfaction
• ulipristal acetate
• fibroids

Disclosure statement

The authors have nothing to disclose and no conflicts of interest to declare.