{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,19]],"date-time":"2025-09-19T20:26:27Z","timestamp":1758313587377,"version":"3.44.0"},"reference-count":26,"publisher":"Georg Thieme Verlag KG","issue":"08","funder":[{"name":"Natural Science Foundation of Chongqing, China","award":["CSTB2022NSCQ-MSX1207"],"award-info":[{"award-number":["CSTB2022NSCQ-MSX1207"]}]},{"name":"Scientific Research cultivation project of Chongqing University Jiangjin Hospital","award":["No. 2024YCXM003, 2023YCXM002"],"award-info":[{"award-number":["No. 2024YCXM003, 2023YCXM002"]}]},{"name":"Outstanding Young Medical Talents Program of Chongqing","award":["YXQN202401"],"award-info":[{"award-number":["YXQN202401"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Horm Metab Res"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Metyrapone and osilodrostat are both steroidogenic inhibitors targeting the\n                    11\u03b2-hydroxylase, yet their safety profile has not been comprehensively analyzed.\n                    The objective of this study is to compare the adverse events (AEs) associated\n                    with osilodrostat and metyrapone based on the Food and Drug Administration\n                    Adverse Event Reporting System (FAERS). AEs were classified according to the\n                    System Organ Class (SOC) in the Medical Dictionary for Regulatory Activities\n                    (MedDRA) version 26.1. Adverse event (AE) signals of osilodrostat and metyrapone\n                    were determined by calculating reporting odds ratios (ROR). A total of 1380 and\n                    449 AE reports were retrieved from osilodrostat and metyrapone, respectively,\n                    involving 26 and 27 SOC categories. Unexpected AEs such as asthenia, decrease of\n                    blood potassium, myalgia, increase of blood pressure, abdominal distension,\n                    increase of blood testosterone, nephrolithiasis, and hunger were associated with\n                    osilodrostat. while metyrapone was linked with respiratory failure, deep vein\n                    thrombosis, interstitial lung disease, liver function test abnormal, and\n                    respiratory distress. Among osilodrostat-treated patients, those aged between 18\n                    to 65 years old were more likely to develop adrenal insufficiency, fatigue,\n                    tachycardia, than those older than 65. Male patients treated with metyrapone\n                    have the significantly higher incidence of the increased blood corticotrophin,\n                    muscular weakness and acute respiratory distress syndrome compared to females.\n                    During treatment with osilodrostat and metyrapone, clinicians need to monitor\n                    the effects of AEs varied by gender and age and to pay more attention to new AE\n                    signals.<\/jats:p>","DOI":"10.1055\/a-2685-7512","type":"journal-article","created":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T22:57:03Z","timestamp":1755557823000},"page":"464-470","source":"Crossref","is-referenced-by-count":0,"title":["Adverse Event Profile Differences Between Metyrapone and\n                    Osilodrostat: A Pharmacovigilance Study of the FDA Adverse Event Reporting\n                    System"],"prefix":"10.1055","volume":"57","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3855-7969","authenticated-orcid":false,"given":"Chunyong","family":"Xia","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Chongqing University Jiangjin Hospital,\n                    Chongqing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lanxin","family":"Hu","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Chongqing University Jiangjin Hospital,\n                    Chongqing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Fan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Chongqing University Jiangjin Hospital,\n                    Chongqing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jie","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Chongqing University Jiangjin Hospital,\n                    Chongqing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ya","family":"Gan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Guang\u2019an People\u2019s Hospital, Sichuan,\n                    China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2025,9,18]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"913","DOI":"10.1016\/S0140-6736(14)61375-1","article-title":"Cushing\u2019s syndrome","volume":"386","author":"A Lacroix","year":"2015","journal-title":"Lancet"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1093\/clinchem\/hvaa036","article-title":"Commentary on cryptogenic Cushing syndrome due to a white lie","volume":"66","author":"G Eisenhofer","year":"2020","journal-title":"Clin Chem"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"101521","DOI":"10.1016\/j.beem.2021.101521","article-title":"Epidemiology and mortality of Cushing\u2019s syndrome","volume":"35","author":"O A Hakami","year":"2021","journal-title":"Best Pract Res Clin Endocrinol Metab"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"e13114","DOI":"10.1111\/jne.13114","article-title":"Clinical presentation and etiology of Cushing\u2019s syndrome: data from ERCUSYN","volume":"34","author":"E Valassi","year":"2022","journal-title":"J Neuroendocrinol"},{"key":"ref5","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1111\/cen.14014","article-title":"The incidence of endogenous Cushing\u2019s syndrome in the modern era","volume":"91","author":"S Wengander","year":"2019","journal-title":"Clin Endocrinol (Oxf)"},{"key":"ref6","doi-asserted-by":"crossref","first-page":"2807","DOI":"10.1210\/jc.2015-1818","article-title":"Treatment of Cushing\u2019s syndrome: an Endocrine Society clinical practice\n                    guideline","volume":"100","author":"L K Nieman","year":"2015","journal-title":"J Clin Endocrinol Metab"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1007\/s12020-020-02432-z","article-title":"Recurrence after pituitary surgery in adult Cushing\u2019s disease: a systematic\n                    review on diagnosis and treatment","volume":"70","author":"L T Braun","year":"2020","journal-title":"Endocrine"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"903545","DOI":"10.3389\/fendo.2022.903545","article-title":"Metyrapone versus osilodrostat in the short-term therapy of endogenous Cushing\u2019s\n                    syndrome: results from a single center cohort study","volume":"13","author":"M Detomas","year":"2022","journal-title":"Front Endocrinol (Lausanne)"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"726","DOI":"10.1007\/s11102-022-01262-8","article-title":"Cushing\u2019s disease: adrenal steroidogenesis inhibitors","volume":"25","author":"R Pivonello","year":"2022","journal-title":"Pituitary"},{"key":"ref10","doi-asserted-by":"crossref","first-page":"1303","DOI":"10.2147\/DDDT.S315359","article-title":"Clinical utility of osilodrostat in Cushing\u2019s disease: review of currently\n                    available literature","volume":"17","author":"M Perosevic","year":"2023","journal-title":"Drug Des Devel Ther"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1007\/s11102-018-0897-z","article-title":"Effectiveness of medical treatment for Cushing\u2019s syndrome: a systematic review\n                    and meta-analysis","volume":"21","author":"LH A Broersen","year":"2018","journal-title":"Pituitary"},{"key":"ref12","doi-asserted-by":"crossref","first-page":"1375","DOI":"10.1210\/jc.2013-2117","article-title":"LCI699, a potent 11\u03b2-hydroxylase inhibitor, normalizes urinary cortisol in\n                    patients with Cushing\u2019s disease: results from a multicenter, proof-of-concept\n                    study","volume":"99","author":"X Bertagna","year":"2014","journal-title":"J Clin Endocrinol Metab"},{"key":"ref13","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1007\/s11102-015-0692-z","article-title":"Osilodrostat, a potent oral 11\u03b2-hydroxylase inhibitor: 22-week, prospective,\n                    phase II study in Cushing\u2019s disease","volume":"19","author":"M Fleseriu","year":"2016","journal-title":"Pituitary"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"748","DOI":"10.1016\/S2213-8587(20)30240-0","article-title":"Efficacy and safety of osilodrostat in patients with Cushing\u2019s disease (LINC 3):\n                    a multicentre phase III study with a double-blind, randomised withdrawal\n                    phase","volume":"8","author":"R Pivonello","year":"2020","journal-title":"Lancet Diabetes Endocrinol"},{"key":"ref15","doi-asserted-by":"crossref","first-page":"1339505","DOI":"10.3389\/fphar.2024.1339505","article-title":"Pulmonary haemorrhage and haemoptysis associated with bevacizumab-related\n                    treatment regimens: a retrospective, pharmacovigilance study using the FAERS\n                    database","volume":"15","author":"H Hu","year":"2024","journal-title":"Front Pharmacol"},{"key":"ref16","doi-asserted-by":"crossref","first-page":"1405023","DOI":"10.3389\/fphar.2024.1405023","article-title":"A real-world pharmacovigilance study of polatuzumab vedotin based on the FDA\n                    adverse event reporting system (FAERS)","volume":"15","author":"D Liu","year":"2024","journal-title":"Front Pharmacol"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"862508","DOI":"10.3389\/fphar.2022.862508","article-title":"Post-marketing safety concerns with secukinumab: a disproportionality analysis\n                    of the FDA adverse event reporting system","volume":"13","author":"Y Shu","year":"2022","journal-title":"Front Pharmacol"},{"key":"ref18","doi-asserted-by":"crossref","first-page":"4101","DOI":"10.7189\/jogh.13.04101","article-title":"Understanding and reporting odds ratios as rate-ratio estimates in case-control\n                    studies","volume":"13","author":"S Kerr","year":"2023","journal-title":"J Glob Health"},{"key":"ref19","doi-asserted-by":"crossref","first-page":"4146","DOI":"10.1210\/jc.2015-2616","article-title":"Effectiveness of metyrapone in treating Cushing\u2019s syndrome: a retrospective\n                    multicenter study in 195 patients","volume":"100","author":"E Daniel","year":"2015","journal-title":"J Clin Endocrinol Metab"},{"key":"ref20","doi-asserted-by":"crossref","first-page":"701","DOI":"10.1007\/s12020-018-1675-4","article-title":"Metyrapone treatment in Cushing\u2019s syndrome: a real-life study","volume":"62","author":"F Ceccato","year":"2018","journal-title":"Endocrine"},{"key":"ref21","doi-asserted-by":"crossref","first-page":"1103","DOI":"10.1507\/endocrj.EJ24-0153","article-title":"Osilodrostat treatment in patients with Cushing\u2019s disease of Asian or non-Asian\n                    origin: a pooled analysis of two phase III randomized trials (LINC 3 and LINC\n                    4)","volume":"71","author":"A Shimatsu","year":"2024","journal-title":"Endocr J"},{"key":"ref22","doi-asserted-by":"crossref","first-page":"1236465","DOI":"10.3389\/fendo.2023.1236465","article-title":"Long-term efficacy and safety of osilodrostat in patients with Cushing\u2019s\n                    disease: results from the LINC 4 study extension","volume":"14","author":"M Gadelha","year":"2023","journal-title":"Front Endocrinol (Lausanne)"},{"key":"ref23","doi-asserted-by":"crossref","first-page":"bnaa002","DOI":"10.1210\/endrev\/bnaa002","article-title":"Dynamics of ACTH and cortisol secretion and implications for disease","volume":"41","author":"S L Lightman","year":"2020","journal-title":"Endocr Rev"},{"key":"ref24","doi-asserted-by":"crossref","first-page":"luae015","DOI":"10.1210\/jcemcr\/luae015","article-title":"Prolonged hypokalemia following metyrapone treatment for primary bilateral\n                    macronodular adrenal cortical disease","volume":"2","author":"Y Kidawara","year":"2024","journal-title":"JCEM Case Rep"},{"key":"ref25","first-page":"17","article-title":"Mineralocorticoid hypertension and hypokalaemia induced by posaconazole","author":"C Boughton","year":"2018","journal-title":"Endocrinol Diabetes Metab Case Rep"},{"key":"ref26","doi-asserted-by":"crossref","first-page":"dgaf226","DOI":"10.1210\/clinem\/dgaf226","article-title":"Approach to the patient: hirsutism","volume":"9","author":"R Azziz","year":"2025","journal-title":"J Clin Endocrinol Metab"}],"container-title":["Hormone and Metabolic Research"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2685-7512.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,18]],"date-time":"2025-09-18T22:53:34Z","timestamp":1758236014000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2685-7512"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8]]},"references-count":26,"journal-issue":{"issue":"08","published-online":{"date-parts":[[2025,9,18]]},"published-print":{"date-parts":[[2025,8]]}},"URL":"https:\/\/doi.org\/10.1055\/a-2685-7512","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0018-5043","1439-4286"],"issn-type":[{"type":"print","value":"0018-5043"},{"type":"electronic","value":"1439-4286"}],"subject":[],"published-other":{"date-parts":[[2025,8,18]]},"published":{"date-parts":[[2025,8]]}}}