Abstract：
UNASSIGNED: Recently, the European Medicines Agency (EMA) received reports of suicidal thoughts and self-injury associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) liraglutide and semaglutide.
UNASSIGNED: Herein, we sought to evaluate suicidality associated with all GLP-1 RAs relative to other glucose-lowering agents currently approved by the United States Food and Drug Administration (FDA). Reports of suicidal ideation, \"depression/suicidal\", suicidal behavior, suicidal attempts, and completed suicide associated with GLP-1 RA exposure reported to the FDA between 2005 and October 2023 were obtained from the FDA Adverse Event Reporting System (FAERS). We present data using the reporting odds ratio (ROR). The ROR was considered significant when the lower limit of the 95% confidence interval (CI) was greater than 1.0.
UNASSIGNED: Disproportionate reporting of suicidal ideation and \"depression/suicidal\" was observed with semaglutide and liraglutide. Disproportionate reporting of suicidal behavior, suicide attempts, and completed suicide was not observed for any of the FDA-approved GLP-1 RAs.
UNASSIGNED: Using the Bradford Hill criteria, however, and taking into consideration confounders, no causal link between GLP-1 RAs and suicidality exists.
UNASSIGNED: Herein, we sought to evaluate suicidality associated with all GLP-1 RAs relative to other glucose-lowering agents currently approved by the United States Food and Drug Administration (FDA). Reports of suicidal ideation, \"depression/suicidal\", suicidal behavior, suicidal attempts, and completed suicide associated with GLP-1 RA exposure reported to the FDA between 2005 and October 2023 were obtained from the FDA Adverse Event Reporting System (FAERS). We present data using the reporting odds ratio (ROR). The ROR was considered significant when the lower limit of the 95% confidence interval (CI) was greater than 1.0.
UNASSIGNED: Disproportionate reporting of suicidal ideation and \"depression/suicidal\" was observed with semaglutide and liraglutide. Disproportionate reporting of suicidal behavior, suicide attempts, and completed suicide was not observed for any of the FDA-approved GLP-1 RAs.
UNASSIGNED: Using the Bradford Hill criteria, however, and taking into consideration confounders, no causal link between GLP-1 RAs and suicidality exists.
摘要：
■最近，欧洲药品管理局(EMA)收到了与胰高血糖素样肽-1受体激动剂(GLP-1RAs)利拉鲁肽和司马鲁肽相关的自杀念头和自我损伤的报告.
■这里，我们试图评估与所有GLP-1RA相关的自杀率,相对于目前由美国食品和药物管理局(FDA)批准的其他降糖药物.自杀意念的报告,抑郁症自杀,自杀行为,从FDA不良事件报告系统(FAERS)获得了2005年至2023年10月期间向FDA报告的与GLP-1暴露相关的自杀企图和完全自杀.我们使用报告比值比(ROR)提供数据。当95%置信区间(CI)的下限大于1.0时,ROR被认为是显著的。
■使用司马鲁肽和利拉鲁肽观察到自杀意念和抑郁症自杀的不成比例报告。不相称的自杀行为报告，对于任何FDA批准的GLP-1RA,均未观察到自杀未遂和完全自杀.
■使用布拉德福德·希尔标准，并考虑到混杂因素，GLP-1RA与自杀之间不存在因果关系.
■这里，我们试图评估与所有GLP-1RA相关的自杀率,相对于目前由美国食品和药物管理局(FDA)批准的其他降糖药物.自杀意念的报告,抑郁症自杀,自杀行为,从FDA不良事件报告系统(FAERS)获得了2005年至2023年10月期间向FDA报告的与GLP-1暴露相关的自杀企图和完全自杀.我们使用报告比值比(ROR)提供数据。当95%置信区间(CI)的下限大于1.0时,ROR被认为是显著的。
■使用司马鲁肽和利拉鲁肽观察到自杀意念和抑郁症自杀的不成比例报告。不相称的自杀行为报告，对于任何FDA批准的GLP-1RA,均未观察到自杀未遂和完全自杀.
■使用布拉德福德·希尔标准，并考虑到混杂因素，GLP-1RA与自杀之间不存在因果关系.
