关键词: Antidepressants Cardiomyopathy FAERS Pharmacovigilance SNRIs SSRIs Spontaneous reporting systems

Mesh : Humans Female Selective Serotonin Reuptake Inhibitors / adverse effects Male Pharmacovigilance Middle Aged Aged Serotonin and Noradrenaline Reuptake Inhibitors / adverse effects Takotsubo Cardiomyopathy / chemically induced epidemiology Adverse Drug Reaction Reporting Systems Adult United States / epidemiology Venlafaxine Hydrochloride / adverse effects Fluoxetine / adverse effects Databases, Factual Risk Factors

来  源:   DOI:10.1038/s41598-024-66155-1   PDF(Pubmed)

Abstract:
Selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) are reported to cause stress cardiomyopathy (SC). This study evaluated the association between SSRI/SNRI use and the occurrence of cardiomyopathy in the publicly available U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionate analysis and likelihood ratio tests were used to identify risk associated with SSRIs or SNRIs and the incidence of SC, using data from between from 2012 to 2022 acquired from the FAERS database. The study identified 132 individual case safety reports (ICSRs) of SC associated with SSRIs or SNRIs. Venlafaxine (48%) and fluoxetine (27%) were the most common antidepressants of the ICSRs. Approximately 80% of SC cases were reported in females, with individuals aged 45-65 years identified as a high-risk population. Both venlafaxine (ratio-scale information component [RSIC] 2.54, 95% CI 2.06-3.04) and fluoxetine (RSIC 3.20, 95% CI 2.31-4.47) were associated with SC, with likelihood ratio estimates of 3.55 (p = 0.02) for venlafaxine and 4.82 (p = 0.008) for fluoxetine. The median time to cardiomyopathy onset was 20 days, with hospitalization reported in 48.33% of patients. Venlafaxine and fluoxetine were associated with SC risk, particularly in middle-aged women. Caution should be exercised when using SSRIs or SNRIs combined with other serotonergic medications.
摘要:
据报道,选择性5-羟色胺再摄取抑制剂(SSRIs)和5-羟色胺和去甲肾上腺素再摄取抑制剂(SNRIs)会引起应激性心肌病(SC)。本研究在公开的美国食品和药物管理局不良事件报告系统(FAERS)数据库中评估了SSRI/SNRI使用与心肌病发生之间的关联。使用不成比例分析和似然比检验来确定与SSRIs或SNRIs相关的风险以及SC的发生率。使用从FAERS数据库获得的2012年至2022年之间的数据。该研究确定了132个与SSRIs或SNRIs相关的SC个体病例安全性报告(ICSR)。文拉法辛(48%)和氟西汀(27%)是ICSR中最常见的抗抑郁药。大约80%的SC病例报告为女性,45-65岁的人被确定为高危人群。文拉法辛(比率量表信息成分[RSIC]2.54,95%CI2.06-3.04)和氟西汀(RSIC3.20,95%CI2.31-4.47)均与SC相关,文拉法辛的似然比估计值为3.55(p=0.02),氟西汀的似然比估计值为4.82(p=0.008)。心肌病发病的中位时间为20天,其中48.33%的患者报告住院。文拉法辛和氟西汀与SC风险相关,尤其是中年妇女。使用SSRIs或SNRIs联合其他5-羟色胺能药物时,应谨慎行事。
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