Ulipristal acetate in the management of symptomatic uterine fibroids: facts and pending issues.

ABSTRACT

Various treatment options have been proposed for the management of human symptomatic uterine fibroids (or myomas). Despite this, the most popular one is surgery (myomectomy or hysterectomy). Ulipristal acetate (UA) is a selective progesterone receptor modulator. In women programmed for surgical treatment for uterine fibroids, oral UA treatment (5 or 10 mg/day) controls symptoms, reduces tumor size and improves quality of life as compared to placebo and is not inferior to monthly intramuscular injection of leuprolide acetate for 3 months. Women treated with up to 4 courses of UA (10 mg/day for 3 months) followed or not by norethisterone acetate (10 mg/day for 10 days or placebo) reported a high rate of bleeding control, and improved quality of life, pain anxiety and depression. Median fibroid volume after successive courses of UA treatment ranged from -63% to -72% as compared to baseline value. Endometrium showed benign histological changes without hyperplasia, while adverse events were mild or moderate throughout the several courses of treatment. There is a need for global cost assessment of UA treatment for uterine fibroids, including those women that do not reach their expected outcome and need other complementary explorations or treatments. Studies are needed in non-Caucasian women, in infertile patients and in cases of fibroids associated with adenomyosis. Furthermore, assessment of long-term UA treatment should include endometrial, cardiocirculatory and neurological endpoints.