Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids

Expert Opinion on Drug Safety
Emanuela TafiSimone Ferrero

Abstract

Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). SPRMs are a new class of progesterone-receptor ligands that exert tissue selective agonist, antagonist or mixed agonist-antagonist activity in target cells. UPA inhibits the proliferation, induces apoptosis of leiomyoma cells in vitro and demonstrates potent progesterone antagonist activity in vitro and in vivo. This manuscript aims to review the available data on safety of UPA in the treatment of uterine fibroids. Data and articles included in this manuscript were obtained via PubMed, Medline and Embase up to November 2014. UPA is efficacious in the treatment of uterine fibroids before surgery; it decreases leiomyoma volume and uterine bleeding; furthermore, it improves quality of life. Short-term administration of UPA has been shown to be safe at short follow-up (months) and it is associated with minimal adverse side effects; further studies with longer follow-up are required to define the safety profile of UPA on endometrial histology.

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Citations

Dec 2, 2015·Expert Opinion on Investigational Drugs·Umberto Leone Roberti Maggiore, Simone Ferrero
Dec 29, 2015·Journal of Minimally Invasive Gynecology·Simone FerreroUmberto Leone Roberti Maggiore
Jul 6, 2015·European Journal of Obstetrics, Gynecology, and Reproductive Biology·Nicolò BizzarriSimone Ferrero
Aug 28, 2016·European Journal of Obstetrics, Gynecology, and Reproductive Biology·Simone FerreroUmberto Leone Roberti Maggiore
Dec 19, 2017·Expert Opinion on Drug Metabolism & Toxicology·Simone FerreroFabio Barra
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Feb 28, 2020·Obstetrical & Gynecological Survey·Salvatore Giovanni VitaleAntonio Cianci
Feb 11, 2021·The Journal of Clinical Endocrinology and Metabolism·Eileen L Yoon, Jin-Sung Yuk

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