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

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.