Hepatotoxizität selektiver Progesteronrezeptormodulatoren

In: Gynäkologische Endokrinologie · 2021 · vol. 19(3) , pp. 228–231 · doi:10.1007/s10304-021-00385-8 · W3159431383
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AI-generated summary by claude@2026-06+body, 2026-06-13

This literature review discusses selective progesterone receptor modulators and their therapeutic utility, citing studies on ulipristal acetate, mifepristone, asoprisnil, CDB4124, telapristone acetate, vilaprisan, and CDB-2914 for uterine fibroid treatment.

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The paper is a narrative review focused on hepatotoxicity associated with selective progesterone receptor modulators, drawing on clinical development and postmarketing data—especially evidence around ulipristal acetate used for uterine fibroids. It discusses reported liver injury signals and summarizes liver safety parameters from the broader literature, including randomized trials and reviews that characterize the risk and clinical context, while noting uncertainty and the possibility that the magnitude of harm may have been exaggerated. A central limitation is that it synthesizes heterogeneous sources rather than presenting new original experiments or a uniform patient-level analysis. Relevance to endometriosis: the paper discusses progesterone receptor modulator safety in the setting of gynecologic conditions (uterine fibroids) with attention to drug liver toxicity, and such mechanistic/safety considerations are often pertinent to endometriosis treatment frameworks that use the same drug class, though endometriosis is not the paper’s main focus.

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Literatur Donnez J, Tatarchuk TF, Bouchard P et al (2012) PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 366:409–420 Islam MS, Afrin S, Jones SI, Segars J (2020) Selective progesterone receptor modulators-mechanisms and therapeutic utility. Endocr Rev 41(5):bnaa12 Kawaguchi K, Fujii S, Konishi I et al (1991) Immunohistochemical analysis of oestrogen receptors, progesterone receptors and Ki-67 in leiomyoma and myometrium during the menstrual cycle and pregnancy. Virchows Arch A Pathol Anat Histopathol 419:309–315 Bouchard P, Chabbert-Buffet N, Fauser BC (2011) Selective progesterone receptor modulators in reproductive medicine: pharmacology, clinical efficacy and safety. Fertil Steril 96:1175–1189 Tristan M, Orozco LJ, Steed A, Ramirez-Morera A, Stone P (2012) Mifepristone for uterine fibroids. 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(2016) A phase 2, study to evaluate the safety and efficacy ProellexR(Telapristone acetate) administered vaginally in the treatment of uterine fibroids. https://clinicaltrials.gov/ct2/show/NCT02323646. Zugegriffen: 15. Febr. 2021 Schutt B, Kaiser A, Schultze-Mosgau MH, Seitz C, Bell D, Koch M, Rohde B (2016) Pharmacodynamics and safety of the novel selective progesterone receptor modulator vilaprisan: a double-blind, randomized, placebo-controlled phase 1 trial in healthy women. Hum Reprod 31:1703–1712 Gemzell-Danielsson K, Heikinheimo O, Zatik J, Poka R, Rechberger T, Hudecek R, Petersdorf K, Ramirez F, Faustmann T, Groettrup-Wolfers E, Seitz C (2020) Efficacy and safety of vilaprisan in women with uterine fibroids: data from the phase 2b randomized controlled trial ASTEROID 2. Eur J Obstet Gynecol Reprod Biol 252:7–14 Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M (2003) Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. 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Hum Reprod 24:1870–1879 Carbonell JL, Acosta R, Pérez Y, Garcés R, Sánchez C, Tomasi G (2013) Treatment of uterine myoma with 2.5 or 5 mg mifepristone daily during 3 months with 9 months posttreatment followup: randomized clinical trial. ISRN Obstet Gynecol 2013:649030 Yerushalmi GM, Gilboa Y, Jakobson-Setton A et al (2014) Vaginal mifepristone for the treatment of symptomatic uterine leiomyomata: an open-label study. Fertil Steril 101:496–500 Stewart EA, Diamond MP, Williams ARW et al (2019) Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod 34:623–634 Donnez J, Arriagada P, Marciniak M, Larrey D (2018) Liver safety parameters of ulipristal acetate for the treatment of uterine fibroids: a comprehensive review of the clinical development program. Expert Opin Drug Saf. https://doi.org/10.1080/14740338.2018.1550070 Donnez J, Vázquez F, Tomaszewski J et al (2014) Longterm treatment of uterine fibroids with ulipristal acetate. Fertil Steril 101:1565–1573 Donnez J (2018) Liver injury and ulipristal acetate: an overstated tragedy? Fertil Steril 110:593–595 Author information Authors and Affiliations Corresponding author Ethics declarations Interessenkonflikt T. Strowitzki gibt an, dass kein Interessenkonflikt besteht. Für diesen Beitrag wurden vom Autor keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien. Additional information Redaktion B. Leeners, Zürich O. Ortmann, Regensburg C. Tempfer, Herne Rights and permissions About this article Cite this article Strowitzki, T. Hepatotoxizität selektiver Progesteronrezeptormodulatoren. Gynäkologische Endokrinologie 19, 228–231 (2021). https://doi.org/10.1007/s10304-021-00385-8 Accepted: Published: Version of record: Issue date: DOI: https://doi.org/10.1007/s10304-021-00385-8

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