Safety of treatment of uterine fibroids with the selective progesterone receptor modulator, ulipristal acetate. Issue 12 (1st December 2016)

• Record Type: Journal Article
• Authors: Donnez, Jacques; Donnez, Olivier; Dolmans, Marie-Madeleine
• Is Part Of: Expert opinion on drug safety. Volume 15:Issue 12(2016)
• Page Start: 1679
• Page End: 1686
• Publication Date: 2016-12-01
• Subjects: Uterine fibroids -- selective progesterone receptors modulators -- ulipristal acetate -- safety -- PAECs (progesterone receptor modulator-associated endometrial changes); Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2016.1248943
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Introduction : During the last decade, there has been increased emphasis on the role of progesterone in the promotion of fibroid growth, as well as heightened interest in modulating progesterone pathways by use of selective progesterone receptor modulators (SPRMs). Among them, ulipristal acetate (UPA) has proved its efficacy in the management of symptomatic myomas by controlling bleeding and inducing amenorrhea, and reducing the size of myomas in the majority of cases. Areas covered : In this review, we summarize published scientific studies exploring evidence of the safety of SPRMs and particularly UPA, a drug approved for the management of symptomatic uterine fibroids. We focus essentially on endometrial changes induced by UPA, and also evaluate other safety outcomes. Expert opinion : Data from published reports of randomized controlled trials (RCTs) over 5 years have demonstrated that UPA does indeed induce endometrial changes (known as progesterone receptor modulator-associated endometrial changes), but they have been shown to be both benign and reversible.