| アブストラクト | BACKGROUND: Drug exposure has been reported in association with Takotsubo syndrome, but the breadth and relative strength of these reporting signals across therapeutic classes remain incompletely characterised. METHODS: We conducted a retrospective pharmacovigilance study using reports submitted to the Food and Drug Administration Adverse Event Reporting System between 2004 and the second quarter of 2025. Takotsubo syndrome reports were identified and analysed using disproportionality methods, including reporting ORs and Bayesian information components. Sensitivity analyses excluded catecholaminergic agents and selected concomitant therapies. RESULTS: Among >22 million adverse event reports, 5213 involved Takotsubo syndrome, predominantly affecting women (74.8%) and older individuals (>60 years: 44.4%). Hospitalisation (51.6%) and life-threatening outcomes (21.7%) were frequently reported. Catecholaminergic agents showed the highest reporting disproportionality, notably dobutamine (reporting OR (ROR) (95% CI) 283.83 (226.55 to 355.60)) and norepinephrine (ROR (95% CI) 160.70 (126.42 to 204.28)). After exclusion of these agents, disproportionate reporting persisted across several non-catecholaminergic drug classes, including antineoplastic and central nervous system-active drugs. Immune checkpoint inhibitors (ICIs) accounted for 219 reports and demonstrated disproportionate reporting. However, pairwise comparisons showed lower disproportionality for ICI-only reports than for carboplatin-only or paclitaxel-only reports. CONCLUSIONS: In spontaneous pharmacovigilance reports, Takotsubo syndrome is disproportionately reported with multiple drug classes, most prominently catecholaminergic agents. Disproportionate reporting with ICIs was observed within an oncology population, although with a lower magnitude than carboplatin and paclitaxel. These findings support cautious clinical awareness while highlighting the need for confirmatory observational studies to clarify absolute risk and underlying mechanisms. |
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| ジャーナル名 | Heart (British Cardiac Society) |
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| Pubmed追加日 | 2026/2/12 |
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| 投稿者 | Tan, Samuel Chin Wei; Loh, Kelly Jia Qi; Yin, Zhao-Wei; Liu, Yi-Shuo; Zhao, Yun-Tao; Weng, Cui-Lian |
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| 組織名 | Department of Cardiology, Peking University Aerospace School of Clinical Medicine;(Aerospace Center Hospital), Beijing, China.;Department of Cardiology and Institute of Vascular Medicine, Peking University;Third Hospital, Beijing, China.;Department of Cardiology, Aerospace Center Hospital, Beijing, China;raas@hsc.pku.edu.cn wengcuilian20051@sina.com.;Department of Intensive Care Unit, The Shengli Clinical Medical College of Fujian;Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated;Provincial Hospital, Fujian Provincial Hospital South Branch, Fuzhou, Fujian,;China raas@hsc.pku.edu.cn wengcuilian20051@sina.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41672765/ |
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