Cao Jinming, Chen Zhicong, Wang Yan, Ma Yunpeng, Yang Zhen, Cai Jian, Xiao Zhijun, Xu Feng
Fengxian Hospital, Southern Medical University, Shanghai, China.
Sixth People's Hospital South Campus, Shanghai Jiaotong University, Shanghai, China.
Front Pharmacol. 2025 Jan 10;15:1517546. doi: 10.3389/fphar.2024.1517546. eCollection 2024.
In the past few decades, selective serotonin reuptake inhibitors (SSRIs) became widely used antidepressants worldwide. Therefore, the adverse reactions of patients after SSRI administration became a public and clinical concern. In this study, we conducted a pharmacovigilance study using the Adverse Event Reporting System (FAERS) database of the US Food and Drug Administration. Our main goal was to evaluate adverse events related to SSRIs, with a particular focus on abnormal weight gain and glucose/lipid metabolism disorders.
The adverse event data for representative SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) was extracted from the FAERS database from 2004Q1 to 2023Q4. The reporting odds ratio and proportional reporting ratio were employed to explore relevant adverse event reports (ADEs) signals. Univariate logistic regression analysis was utilized to explore factors associated with glucose/lipid metabolism abnormality following SSRIs treatment.
We identified 143,744 ADE reports associated with SSRIs and revealed significant abnormal signals related to weight gain and glucose/lipid metabolism in depressed patients. Variations were observed among different SSRIs medications. Specifically, citalopram was associated with abnormal weight gain (ROR: 4, 95% CI: 3.1-5.2) and hepatic steatosis (ROR: 2.8, 95% CI: 2.1-3.6); escitalopram was correlated with gestational diabetes (ROR: 9.1, 95% CI: 6.6-12.4) and cholestasis (ROR: 2.4, 95% CI: 1.75-3.38); fluoxetine was associated with obesity (ROR: 2.8, 95% CI: 2.08-3.78); fluvoxamine was linked to arteriospasm coronary (ROR: 13.87, 95% CI: 4.47-43.1); and sertraline was implicated in neonatal jaundice (ROR: 16.1, 95% CI: 12.6-20.6). Females and younger age are important risk factors for the development of associated adverse effects.
Our study screened for adverse effects associated with abnormal glucose/lipid metabolism, such as abnormal body weight and fatty liver, in depressed patients taking selective serotonin reuptake inhibitors by utilizing FAERS database. This provides valuable insights for healthcare professionals in accepting and managing patients treated with SSRIs.
在过去几十年中，选择性5-羟色胺再摄取抑制剂（SSRIs）在全球范围内成为广泛使用的抗抑郁药。因此，患者服用SSRI后的不良反应成为公众和临床关注的问题。在本研究中，我们使用美国食品药品监督管理局的不良事件报告系统（FAERS）数据库进行了一项药物警戒研究。我们的主要目标是评估与SSRI相关的不良事件，特别关注体重异常增加和糖/脂代谢紊乱。
从FAERS数据库中提取2004年第一季度至2023年第四季度代表性SSRI（西酞普兰、艾司西酞普兰、氟西汀、氟伏沙明、帕罗西汀、舍曲林）的不良事件数据。采用报告比值比和比例报告比来探索相关不良事件报告（ADEs）信号。利用单因素逻辑回归分析来探索SSRI治疗后与糖/脂代谢异常相关的因素。
我们识别出143,744份与SSRI相关的ADE报告，并揭示了抑郁症患者体重增加和糖/脂代谢相关的显著异常信号。不同的SSRI药物之间存在差异。具体而言，西酞普兰与体重异常增加（报告比值比：4，95%置信区间：3.1-5.2）和肝脂肪变性（报告比值比：2.8，95%置信区间：2.1-3.6）相关；艾司西酞普兰与妊娠期糖尿病（报告比值比：9.1，95%置信区间：�.6-12.4）和胆汁淤积（报告比值比：2.4，95%置信区间：1.75-3.38）相关；氟西汀与肥胖（报告比值比：2.8，95%置信区间：2.08-3.78）相关；氟伏沙明与冠状动脉痉挛（报告比值比：13.87，95%置信区间：4.47-43.1）相关；舍曲林与新生儿黄疸（报告比值比：16.1，95%置信区间：12.6-20.6）相关。女性和较年轻年龄是发生相关不良反应的重要危险因素。
我们的研究通过利用FAERS数据库，筛查了服用选择性5-羟色胺再摄取抑制剂的抑郁症患者中与糖/脂代谢异常相关的不良反应，如体重异常和脂肪肝。这为医疗保健专业人员接受和管理接受SSRI治疗的患者提供了有价值的见解。
