Ulipristal Acetate: A Review in Symptomatic Uterine Fibroids
- 4 Downloads
Oral ulipristal acetate (Esmya®; Fibristal®), a synthetic selective progesterone receptor modulator, is the first selective progesterone modulator to be approved for the treatment of uterine fibroids. It was initially approved for the preoperative treatment of moderate to severe uterine fibroid symptoms in women of reproductive age. Recently, the indication was extended in the EU to include the intermittent treatment of moderate to severe uterine fibroid symptoms. This narrative review summarizes pharmacological, efficacy and tolerability data relevant to the preoperative and intermittent use of ulipristal acetate in patients with symptomatic uterine fibroids. Ulipristal acetate is an effective and generally well tolerated treatment for patients with symptomatic uterine fibroids, both as preoperative, single-course treatment and as intermittent, longer-term treatment. It is noninferior in efficacy to intramuscular leuprolide acetate, as a preoperative treatment, and is associated with a lower rate of hot flashes, a common adverse event with gonadotropin-releasing hormone analogues. Thus, ulipristal acetate is an effective option for both preoperative and intermittent treatment of moderate to severe, symptomatic uterine fibroids in women of reproductive age.
- 3.National Institute for Health and Care Excellence. Heavy menstrual bleeding: assessment and management. Clinical guideline cg44. 2016. http://www.nice.org.uk. Accessed 5 Apr 2017.
- 5.European Medicines Agency. Esmya® (ulipristal acetate 5 mg tablets): EU summary of product characteristics. 2016. http://www.ema.europa.eu/. Accessed 15 Mar 2017.
- 7.Horak P, Mara M, Dundr P, et al. Effect of a selective progesterone receptor modulator on induction of apoptosis in uterine fibroids in vivo. Int J Endocrinol. 2012;2012:436174.Google Scholar
- 8.Cox J, Malik M, Britten-Webb J, et al. Ulipristal acetate inhibits extracellular matrix production in human leiomyomas in vivo: a laboratory analysis of a randomized controlled trial [abstract]. Reprod Sci. 2015;22(1 Suppl):88A.Google Scholar
- 9.Courtoy GE, Donnez J, Marbaix E, et al. In vivo mechanisms of uterine fibroid volume reduction with ulipristal acetate treatment [abstract no. ES25-0451]. Gynecol Surg. 2016;13(Suppl 1):S69.Google Scholar
- 10.Courtoy GE, Donnez J, Marbaix E, et al. In vivo mechanisms of uterine myoma volume reduction with ulipristal acetate treatment. Fertil Steril. 2015;104(2):426–34.e1.Google Scholar
- 15.Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab. 2007;92(9):3582–9.CrossRefPubMedGoogle Scholar
- 22.Donnez J, Vazquez F, Tomaszewski J, et al. Long-term treatment of uterine fibroids with ulipristal acetate. Fertil Steril. 2014;101(6):1565–73.e1-18.Google Scholar
- 23.Donnez J, Hudecek R, Donnez O, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015;103(2):519–27.e3.Google Scholar
- 24.Donnez J, Donnez O, Matule D, et al. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016;105(1):165–73.e4.Google Scholar
- 26.European Medicines Agency. European public assessment report (EPAR) for Esmya. 2015. http://www.ema.europa.eu. Accessed 17 Aug 2017.
- 27.Raga F, Moscardo I, Cholvi S, et al. Does ulipristal acetate administration for symptomatic uterine fibroids impact ovarian reserve? [abstract]. In: 32nd Annual Meeting of the European Society of Human Reproduction and Embryology. 2016.Google Scholar
- 29.Perez-Lopez FR, Ornat L, Ceausu I, et al. EMAS position statement: management of uterine fibroids. Maturitas. 2014;79(1):106-16.Google Scholar
- 30.Czuczwar P, Wozniak S, Szkodziak P, et al. Influence of ulipristal acetate therapy compared with uterine artery embolization on fibroid volume and vascularity indices assessed by three-dimensional ultrasound: prospective observational study. Ultrasound Obstetr Gynecol. 2015;45(6):744–50.CrossRefGoogle Scholar