{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T03:32:19Z","timestamp":1785209539994,"version":"3.55.0"},"reference-count":24,"publisher":"The Endocrine Society","issue":"6","license":[{"start":{"date-parts":[[2021,2,10]],"date-time":"2021-02-10T00:00:00Z","timestamp":1612915200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,5,13]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>Large-scale clinical trials on the hepatotoxicity of ulipristal acetate (UPA) are lacking.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>This work aimed to determine the incidence of liver disease with UPA vs gonadotropin-releasing hormone (GnRH) agonists.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A retrospective cohort study was conducted in South Korea of women with uterine fibroids from the Korean Health Insurance Data 2010 to 2018. Women with uterine fibroids were divided into 2 treatment groups: the UPA (5 mg\/day) and GnRH agonist groups. Main outcome measures included the presence or absence of severe liver disease, mild liver disease, and liver transplantation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among the patients with uterine fibroids,17\u2005207 patients were treated with GnRH agonists and 20\u2005926 patients with UPA. After 1:1 propensity score matching for each group, there were 11\u2005445 individuals. Neither group had a liver transplantation case. In the conditional logistic regression analysis, the incidence of total liver diseases (relative risk [RR] 1.111; 95% CI, 1.015-1.216) and mild liver diseases (RR 1.094; 95% CI, 1-1.196) was higher in the UPA group than in the GnRH agonist group, but that of severe liver diseases (RR 0.07; 95% CI, 0.001-4.412) and toxic liver disease (RR 1.256; 95% CI, 0.845-1.867) did not differ between the groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The incidence of severe liver disease, hepatic failure, and toxic liver disease was not different between the UPA and GnRH agonist groups. However, the incidence of mild liver disease was higher in the UPA group than in the GnRH agonist group. The incidence of hepatic damage with UPA was very low.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgab081","type":"journal-article","created":{"date-parts":[[2021,2,10]],"date-time":"2021-02-10T17:35:22Z","timestamp":1612978522000},"page":"1773-1782","source":"Crossref","is-referenced-by-count":21,"title":["Use of Ulipristal Acetate and Risk of Liver Disease: A Nationwide Cohort Study"],"prefix":"10.1210","volume":"106","author":[{"given":"Eileen L","family":"Yoon","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seongdong-gu, Seoul 04763, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5478-634X","authenticated-orcid":false,"given":"Jin-Sung","family":"Yuk","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Sanggye Paik Hospital, School of Medicine, Inje University, Nowon-gu, Seoul 01757, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"80","published-online":{"date-parts":[[2021,2,10]]},"reference":[{"key":"2021122205111661800_CIT0001","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1016\/j.bpobgyn.2017.09.004","article-title":"Epidemiology and risk factors of uterine fibroids","volume":"46","author":"Pavone","year":"2018","journal-title":"Best Pract Res Clin Obstet Gynaecol."},{"key":"2021122205111661800_CIT0002","doi-asserted-by":"crossref","first-page":"16043","DOI":"10.1038\/nrdp.2016.43","article-title":"Uterine fibroids","volume":"2","author":"Stewart","year":"2016","journal-title":"Nat Rev Dis Primers."},{"issue":"2","key":"2021122205111661800_CIT0003","first-page":"100","article-title":"Uterine fibroids: diagnosis and treatment","volume":"95","author":"De La Cruz","year":"2017","journal-title":"Am Fam Physician."},{"issue":"2","key":"2021122205111661800_CIT0004","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/j.ijgo.2015.04.051","article-title":"Prevalence, morbidity, and current medical management of uterine leiomyomas","volume":"131","author":"Drayer","year":"2015","journal-title":"Int J Gynaecol Obstet."},{"issue":"6","key":"2021122205111661800_CIT0005","doi-asserted-by":"crossref","first-page":"563","DOI":"10.1016\/j.ajog.2017.12.206","article-title":"The past, present, and future of selective progesterone receptor modulators in the management of uterine fibroids","volume":"218","author":"Singh","year":"2018","journal-title":"Am J Obstet Gynecol."},{"issue":"12","key":"2021122205111661800_CIT0006","doi-asserted-by":"crossref","first-page":"1225","DOI":"10.1080\/14740338.2018.1550070","article-title":"Liver safety parameters of ulipristal acetate for the treatment of uterine fibroids: a comprehensive review of the clinical development program","volume":"17","author":"Donnez","year":"2018","journal-title":"Expert Opin Drug Saf."},{"issue":"5","key":"2021122205111661800_CIT0007","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1056\/NEJMoa1103180","article-title":"Ulipristal acetate versus leuprolide acetate for uterine fibroids","volume":"366","author":"Donnez","year":"2012","journal-title":"N Engl J Med."},{"issue":"6","key":"2021122205111661800_CIT0008","doi-asserted-by":"crossref","first-page":"965","DOI":"10.1517\/14740338.2015.1021773","article-title":"Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids","volume":"14","author":"Tafi","year":"2015","journal-title":"Expert Opin Drug Saf."},{"issue":"6","key":"2021122205111661800_CIT0009","doi-asserted-by":"crossref","first-page":"665","DOI":"10.1093\/humupd\/dmw023","article-title":"Uterine fibroid management: from the present to the future","volume":"22","author":"Donnez","year":"2016","journal-title":"Hum Reprod Update."},{"key":"2021122205111661800_CIT0010","author":"European Medicines Agency","year":"2020"},{"key":"2021122205111661800_CIT0011","doi-asserted-by":"crossref","first-page":"e2014008","DOI":"10.4178\/epih\/e2014008","article-title":"A guide for the utilization of health insurance review and assessment service national patient samples","volume":"36","author":"Kim","year":"2014","journal-title":"Epidemiol Health."},{"issue":"6","key":"2021122205111661800_CIT0012","doi-asserted-by":"crossref","first-page":"676","DOI":"10.1093\/aje\/kwq433","article-title":"Updating and validating the Charlson Comorbidity Index and score for risk adjustment in hospital discharge abstracts using data from 6 countries","volume":"173","author":"Quan","year":"2011","journal-title":"Am J Epidemiol."},{"issue":"5","key":"2021122205111661800_CIT0013","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1056\/NEJMoa1103182","article-title":"Ulipristal acetate versus placebo for fibroid treatment before surgery","volume":"366","author":"Donnez","year":"2012","journal-title":"N Engl J Med."},{"issue":"6","key":"2021122205111661800_CIT0014","doi-asserted-by":"crossref","first-page":"1565","DOI":"10.1016\/j.fertnstert.2014.02.008","article-title":"Long-term treatment of uterine fibroids with ulipristal acetate","volume":"101","author":"Donnez","year":"2014","journal-title":"Fertil Steril"},{"issue":"3","key":"2021122205111661800_CIT0015","doi-asserted-by":"crossref","first-page":"e0173523","DOI":"10.1371\/journal.pone.0173523","article-title":"Safety after extended repeated use of ulipristal acetate for uterine fibroids","volume":"12","author":"Fauser","year":"2017","journal-title":"PloS One."},{"issue":"1","key":"2021122205111661800_CIT0016","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1016\/j.fertnstert.2015.09.032","article-title":"Long-term medical management of uterine fibroids with ulipristal acetate","volume":"105","author":"Donnez","year":"2016","journal-title":"Fertil Steril."},{"issue":"3","key":"2021122205111661800_CIT0017","doi-asserted-by":"crossref","first-page":"431","DOI":"10.1097\/AOG.0000000000002462","article-title":"Ulipristal acetate for treatment of symptomatic uterine leiomyomas: a randomized controlled trial","volume":"131","author":"Simon","year":"2018","journal-title":"Obstet Gynecol."},{"issue":"5","key":"2021122205111661800_CIT0018","doi-asserted-by":"crossref","first-page":"1241","DOI":"10.1097\/AOG.0000000000002942","article-title":"Ulipristal acetate for treatment of uterine leiomyomas: a randomized controlled trial","volume":"132","author":"Liu","year":"2018","journal-title":"Obstet Gynecol."},{"issue":"1","key":"2021122205111661800_CIT0019","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1002\/rmb2.12304","article-title":"Ulipristal acetate for Japanese women with symptomatic uterine fibroids: a double-blind, randomized, phase II dose-finding study","volume":"19","author":"Irahara","year":"2020","journal-title":"Reprod Med Biol."},{"issue":"1","key":"2021122205111661800_CIT0020","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1111\/aogs.13713","article-title":"Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): short-term results of a double-blind randomized controlled trial","volume":"99","author":"de Milliano","year":"2020","journal-title":"Acta Obstet Gynecol Scand."},{"issue":"2","key":"2021122205111661800_CIT0021","doi-asserted-by":"crossref","first-page":"779","DOI":"10.1124\/pr.113.007450","article-title":"Idiosyncratic adverse drug reactions: current concepts","volume":"65","author":"Uetrecht","year":"2013","journal-title":"Pharmacol Rev."},{"key":"2021122205111661800_CIT0022","author":"Korea Disease Statistics"},{"issue":"1","key":"2021122205111661800_CIT0023","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1038\/bjc.1977.1","article-title":"Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples","volume":"35","author":"Peto","year":"1977","journal-title":"Br J Cancer."},{"issue":"6","key":"2021122205111661800_CIT0024","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1016\/0021-9681(86)90111-6","article-title":"Assessing illness severity: does clinical judgment work?","volume":"39","author":"Charlson","year":"1986","journal-title":"J Chronic Dis."}],"container-title":["The Journal of Clinical Endocrinology &amp; Metabolism"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/jcem\/advance-article-pdf\/doi\/10.1210\/clinem\/dgab081\/36447025\/dgab081.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jcem\/article-pdf\/106\/6\/1773\/41851199\/dgab081.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jcem\/article-pdf\/106\/6\/1773\/41851199\/dgab081.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,22]],"date-time":"2021-12-22T05:11:51Z","timestamp":1640149911000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jcem\/article\/106\/6\/1773\/6132476"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2,10]]},"references-count":24,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,2,10]]},"published-print":{"date-parts":[[2021,5,13]]}},"URL":"https:\/\/doi.org\/10.1210\/clinem\/dgab081","relation":{},"ISSN":["0021-972X","1945-7197"],"issn-type":[{"value":"0021-972X","type":"print"},{"value":"1945-7197","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,6,1]]},"published":{"date-parts":[[2021,2,10]]}}}