Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao
{"title":"对利普瑞林相关不良事件的全面评估:美国食品药品管理局不良事件报告系统的启示。","authors":"Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao","doi":"10.1080/14740338.2024.2423680","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.</p><p><strong>Results: </strong>A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (<i>n</i> = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (<i>n</i> = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (<i>n</i> = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).</p><p><strong>Conclusion: </strong>Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0000,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system.\",\"authors\":\"Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao\",\"doi\":\"10.1080/14740338.2024.2423680\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.</p><p><strong>Results: </strong>A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (<i>n</i> = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (<i>n</i> = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (<i>n</i> = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).</p><p><strong>Conclusion: </strong>Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.</p>\",\"PeriodicalId\":12232,\"journal\":{\"name\":\"Expert Opinion on Drug Safety\",\"volume\":\" \",\"pages\":\"1-10\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2024-10-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Opinion on Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14740338.2024.2423680\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Opinion on Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14740338.2024.2423680","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system.
Background: Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.
Methods: This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.
Results: A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (n = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (n = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (n = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).
Conclusion: Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.
期刊介绍:
Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports.
Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.