Ulipristal acetate in symptomatic uterine fibroids. A real-world experience in a multicentric Italian study

Abstract

Surgery is the most frequent treatment in women with symptomatic uterine fibroids. A new medical approach with ulipristal acetate (UPA) has been suggested. The aim of this study was to provide data on effectiveness and safety of UPA in premenopausal women with symptomatic uterine fibroids. This was a multicenter retrospective cohort study. Data on all consecutive premenopausal women with symptomatic uterine fibroids referred to three Italian centers were included in a dedicated merged database. Women aged 18–55 years, who received pharmacologic therapy with UPA 5 mg orally once a day, were included in the study. The primary outcome was the percentage of women who underwent surgery after UPA treatment. One hundred and forty-two premenopausal women with uterine fibroids were included in this study. The mean age was 43.2 years. Eighty-one (57.0%) of 142 women treated with UPA had only medical treatment and did not undergo surgery. Surgical treatment occurred in 70, 23, 32, and 8% of the women who received one course, two courses, three courses, or four courses, of UPA treatment, respectively. The incidence of side effects was 10.6%. The effectiveness and safety of repeated UPA treatment courses in reducing number of women requiring surgery is confirmed by real-world data.

摘要

手术是症状性子宫肌瘤最常用的治疗方式。提出了一种用醋酸乌利司他（UPA）治疗的新方法。本研究旨在提供UPA治疗绝经前女性症状性子宫肌瘤有效性和安全性的数据。该研究是一项多中心回顾性队列研究。3个意大利中心中, 所有患症状性子宫肌瘤的绝经前女性其数据被纳入到一项专门整合的数据库中。18-55岁、接受UPA5mg/天口服治疗的女性被纳入研究。主要结局是UPA治疗后进行手术的女性的比例。研究纳入了142名患子宫肌瘤的更年期前女性。其平均年龄为43.2岁。142名绝经前女性中, 81名（57.0%）仅用了UPA治疗未进行手术。接受1, 2, 3, 4个疗程UPA治疗的女性其手术治疗的比例分别是70%, 23%, 32%和8%。不良反应的发生率为10.6%。真实世界数据证实了反复UPA治疗在减少需要手术女性的人数方面的有效性和安全性。

Keywords:

• Ulipristal
• assisted reproductive technology
• myoma
• anemia
• myomectomy

Disclosure statement

The authors report no conflict of interest.