Ulipristal acetate--a review of the new therapeutic indications and future prospects.

Uterine leiomyomata (ULM) are benign smooth muscle neoplasms that are hormone-dependent. Menorrhagia and anemia are the most common symptoms associated with this disorder. As many as 200000 cases of ULM per year are registered in the USA, and hysterectomy remains the major therapeutic option for treatment. Because gonadal hormones induce or maintain leiomyoma growth, selective progesterone receptor modulators have been evaluated as suitable therapeutic agents. Ulipristal acetate (UPA) is a therapeutic agent used as an emergency contraceptive agent. The therapeutic spectrum of the agent has been expanded by a new indication at the end of 2012. Based on two large-scale international randomized trials (PEARL I and PEARL II), UPA (Esmya tab. 5 mg) received European approval for preoperative treatment of ULM in the spring of 2012. The drug is indicated for treatment of moderate to severe symptoms of uterine fibroids. The duration of the treatment with UPA is limited to no more than 3 months when it is used to reduce the size of the tumor, to stop or reduce bleeding and to increase the red blood count prior to surgery. A disadvantage of the cited studies is that the course of treatment is limited to 3 months. Therefore, more data are needed regarding the benefits and risks of long-term treatment with UPA. The use of UPA in some forms of hypermenorrhoea is discussed as a future therapeutic option but the data are not yet conclusive.