Yujia Xi, Zhuocheng Bao, Qiang Guo, Jingqi Wang, Zhinan Jing, Jingkai Di, Ke Yang
{"title":"血清素-去甲肾上腺素再摄取抑制剂诱发的生殖毒性:基于 FAERS 数据库的 2004 年至 2023 年药物警戒分析。","authors":"Yujia Xi, Zhuocheng Bao, Qiang Guo, Jingqi Wang, Zhinan Jing, Jingkai Di, Ke Yang","doi":"10.1111/cns.70176","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aim</h3>\n \n <p>Serotonin-norepinephrine reuptake inhibitors (SNRIs) have been extensively utilized for the treatment of depression and anxiety disorders. Clinical trials and real-world data suggest that SNRIs may cause reproductive toxicity. To comprehensively assess this association, we conducted a pharmacovigilance study.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>We utilized various disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS), to assess the significance of reproductive toxicity-related adverse events (AEs) reported to FDA Adverse Event Reporting System (FAERS) from January 2004 to December 2023, with subgroup analysis conducted by sex and age.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Duloxetine and venlafaxine were associated with 14 and 25 AE signals related to reproductive toxicity, respectively, with erectile dysfunction (ED) and retrograde ejaculation identified as shared important medical events (IMEs). ED had the highest reporting frequency, strongest in venlafaxine-treated patients under 45 years (ROR 4.34, PRR 4.33, IC 2.09, EBGM 4.25). Retrograde ejaculation was newly identified. With decreasing incidence, venlafaxine's median ED onset was 122.5 days and duloxetine's 38 days.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Our study provides evidence through an extensive analysis of the large-scale real-world FAERS database, aiding healthcare professionals in mitigating, and prioritizing SNRI-related reproductive toxicity AEs.</p>\n </section>\n </div>","PeriodicalId":154,"journal":{"name":"CNS Neuroscience & Therapeutics","volume":"30 12","pages":""},"PeriodicalIF":4.8000,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638886/pdf/","citationCount":"0","resultStr":"{\"title\":\"Reproductive Toxicity Induced by Serotonin-Norepinephrine Reuptake Inhibitors: A Pharmacovigilance Analysis From 2004 to 2023 Based on the FAERS Database\",\"authors\":\"Yujia Xi, Zhuocheng Bao, Qiang Guo, Jingqi Wang, Zhinan Jing, Jingkai Di, Ke Yang\",\"doi\":\"10.1111/cns.70176\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Aim</h3>\\n \\n <p>Serotonin-norepinephrine reuptake inhibitors (SNRIs) have been extensively utilized for the treatment of depression and anxiety disorders. Clinical trials and real-world data suggest that SNRIs may cause reproductive toxicity. To comprehensively assess this association, we conducted a pharmacovigilance study.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>We utilized various disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS), to assess the significance of reproductive toxicity-related adverse events (AEs) reported to FDA Adverse Event Reporting System (FAERS) from January 2004 to December 2023, with subgroup analysis conducted by sex and age.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Duloxetine and venlafaxine were associated with 14 and 25 AE signals related to reproductive toxicity, respectively, with erectile dysfunction (ED) and retrograde ejaculation identified as shared important medical events (IMEs). ED had the highest reporting frequency, strongest in venlafaxine-treated patients under 45 years (ROR 4.34, PRR 4.33, IC 2.09, EBGM 4.25). Retrograde ejaculation was newly identified. With decreasing incidence, venlafaxine's median ED onset was 122.5 days and duloxetine's 38 days.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Our study provides evidence through an extensive analysis of the large-scale real-world FAERS database, aiding healthcare professionals in mitigating, and prioritizing SNRI-related reproductive toxicity AEs.</p>\\n </section>\\n </div>\",\"PeriodicalId\":154,\"journal\":{\"name\":\"CNS Neuroscience & Therapeutics\",\"volume\":\"30 12\",\"pages\":\"\"},\"PeriodicalIF\":4.8000,\"publicationDate\":\"2024-12-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638886/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CNS Neuroscience & Therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/cns.70176\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NEUROSCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CNS Neuroscience & Therapeutics","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/cns.70176","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
引用次数: 0
摘要
目的:血清素-去甲肾上腺素再摄取抑制剂(SNRIs)已被广泛用于治疗抑郁症和焦虑症。临床试验和实际数据表明,SNRIs可能导致生殖毒性。为了全面评估这种关联,我们进行了一项药物警戒研究。方法:采用报告优势比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽玛泊松收缩器(MGPS)等多种歧化分析算法,对2004年1月至2023年12月FDA不良事件报告系统(FAERS)报告的生殖毒性相关不良事件(ae)的意义进行评估,并按性别和年龄进行亚组分析。结果:度洛西汀和文拉法辛分别与生殖毒性相关的14和25个AE信号相关,勃起功能障碍(ED)和逆行射精被确定为共同的重要医学事件(IMEs)。ED的报告频率最高,在45岁以下文拉法辛治疗的患者中最强(ROR 4.34, PRR 4.33, IC 2.09, EBGM 4.25)。新近发现了逆行射精。随着发病率的降低,文拉法辛的ED发病中位数为122.5天,度洛西汀为38天。结论:我们的研究通过对大规模真实世界FAERS数据库的广泛分析提供了证据,帮助医疗保健专业人员减轻和优先处理snri相关的生殖毒性ae。
Reproductive Toxicity Induced by Serotonin-Norepinephrine Reuptake Inhibitors: A Pharmacovigilance Analysis From 2004 to 2023 Based on the FAERS Database
Aim
Serotonin-norepinephrine reuptake inhibitors (SNRIs) have been extensively utilized for the treatment of depression and anxiety disorders. Clinical trials and real-world data suggest that SNRIs may cause reproductive toxicity. To comprehensively assess this association, we conducted a pharmacovigilance study.
Methods
We utilized various disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS), to assess the significance of reproductive toxicity-related adverse events (AEs) reported to FDA Adverse Event Reporting System (FAERS) from January 2004 to December 2023, with subgroup analysis conducted by sex and age.
Results
Duloxetine and venlafaxine were associated with 14 and 25 AE signals related to reproductive toxicity, respectively, with erectile dysfunction (ED) and retrograde ejaculation identified as shared important medical events (IMEs). ED had the highest reporting frequency, strongest in venlafaxine-treated patients under 45 years (ROR 4.34, PRR 4.33, IC 2.09, EBGM 4.25). Retrograde ejaculation was newly identified. With decreasing incidence, venlafaxine's median ED onset was 122.5 days and duloxetine's 38 days.
Conclusion
Our study provides evidence through an extensive analysis of the large-scale real-world FAERS database, aiding healthcare professionals in mitigating, and prioritizing SNRI-related reproductive toxicity AEs.
期刊介绍:
CNS Neuroscience & Therapeutics provides a medium for rapid publication of original clinical, experimental, and translational research papers, timely reviews and reports of novel findings of therapeutic relevance to the central nervous system, as well as papers related to clinical pharmacology, drug development and novel methodologies for drug evaluation. The journal focuses on neurological and psychiatric diseases such as stroke, Parkinson’s disease, Alzheimer’s disease, depression, schizophrenia, epilepsy, and drug abuse.