Medical Therapy for Fibroids: What Next for Ulipristal Acetate?
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REVIEW
Medical Therapy for Fibroids: What Next for Ulipristal Acetate? Emmanuel Ekanem
. Vikram Talaulikar
Received: September 10, 2020 / Accepted: October 28, 2020 Ó The Author(s) 2020
ABSTRACT Ulipristal acetate (UPA) was introduced as a novel progesterone receptor modulator as effective therapy for symptomatic fibroids. Randomised clinical trials established its effectiveness in the management of heavy menstrual bleeding due to uterine leiomyomas. The trials did not find any significant evidence of clinical harm to the participants. Recently, however, there have been reports of liver injury necessitating liver transplant in women who have had UPA treatment. This has led to the suspension of UPA as one of the medical therapies in the
treatment for uterine fibroids while the European Medicines Agency (EMA) conducts a review of liver injury risk with its use. The European Medicine Agency safety committee has advised that women should stop taking 5 mg UPA and that no new patients should commence treatment with the medicine until the ongoing review is completed. In this article, we review the rise of UPA as one of the emerging medical therapies for symptomatic uterine fibroids and the subsequent reports of adverse events leading to the suspension of its use.
Keywords: Fibroids; Medical; Ulipristal acetate; Women’s health
E. Ekanem (&) Speciality Trainee in Obstetrics and Gynaecology, University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK e-mail: [email protected] V. Talaulikar Reproductive Medicine Unit, University College London Hospital, 235 Euston Road, London NW1 2BU, UK
Adv Ther
Key Summary Points Ulipristal acetate (UPA) is selective progesterone receptor modulator effective for the treatment of symptomatic uterine fibroids Randomised clinical trials established its effectiveness in the management of heavy menstrual bleeding due to uterine leiomyomas. The trials did not find any significant evidence of clinical harm to the participants Recently, however, there have been reports of liver injury necessitating liver transplant in women who have had UPA treatment This has led to the suspension of UPA as one of the medical therapies in the treatment for uterine fibroids while the European Medicines Agency (EMA) conducts a review of liver injury risk with its use In this article, we review the rise of UPA as one of the emerging medical therapies for symptomatic uterine fibroids and the subsequent reports of adverse events leading to the suspension of its use
DIGITAL FEATURES This article is published with digital features, including a summary slide, to facilitate understanding of the article. To view digital features for this article go to https://doi.org/10.6084/ m9.figshare.13143791.
INTRODUCTION AND OVERVIEW OF MEDICAL TREATMENTS FOR UTERINE FIBROIDS Ulipristal acetate (UPA) is one of the selective progesterone receptor modulators (SPRMs) that
was found useful in treating women with symptomatic uterine fibroids in addition to its use as an effective emergency contraceptive. Initially
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