| アブストラクト | Semaglutide is widely used to treat type 2 diabetes and obesity and to reduce cardiovascular risk. However, its association with cardiac rhythm-related adverse-event reporting in routine clinical practice remains incompletely characterized. To investigate cardiovascular and rhythm-related adverse-event reporting associated with semaglutide, with a focus on ventricular extrasystoles, we conducted a disproportionality analysis of individual case safety reports from VigiBase and the FDA Adverse Event Monitoring System (AEMS; formerly the FDA Adverse Event Reporting System [FAERS]). Reports were included when semaglutide was recorded as a suspected drug, according to database-specific criteria. Cardiovascular outcomes were identified using Medical Dictionary for Regulatory Activities Preferred Terms. Reporting odds ratios (RORs) and 95% confidence intervals (CIs) were calculated. A cross-database reporting signal was defined as at least three semaglutide-associated reports and a lower 95% CI bound exceeding 1 in each database. After deduplication and application of the predefined inclusion criteria, 1980 semaglutide-associated cardiovascular reports from VigiBase and 1754 from AEMS were included. Among the screened cardiovascular and rhythm-related preferred terms, ventricular extrasystoles was the only term that met the prespecified signal criterion in both databases. Ventricular extrasystoles, clinically corresponding to premature ventricular contractions, showed disproportionate reporting in VigiBase (ROR 1.77, 95% CI 1.31-2.40) and AEMS (ROR 1.37, 95% CI 1.00-1.88; unrounded lower CI bound > 1). Ventricular extrasystoles showed a consistent disproportionality signal across VigiBase and AEMS. Although spontaneous reporting data cannot establish incidence, causality, or prognostic significance, this finding warrants prospective investigation using systematic electrocardiographic assessment and ambulatory rhythm monitoring. |
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| 投稿者 | Wu, Daobin; Yang, Rongying; Zeng, Jun; Bai, Zhou; Zhang, Chunda; Fan, Xinrong; Zhou, Xiangyu; Wu, Lin; Zhu, Sui; Akin, Ibrahim; Zhou, Xiaobo; Chang, Lijia; Hashimoto, Kenji; Wei, Yan |
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| 組織名 | Key Laboratory of Medical Electrophysiology, Ministry of Education & Medical;Electrophysiological Key Laboratory of Sichuan Province, (Collaborative;Innovation Center for Prevention of Cardiovascular Diseases), Institute of;Cardiovascular Research, Southwest Medical University, Luzhou, 646000, Sichuan,;China.;Department of Cardiology, The Affiliated Hospital, Southwest Medical University,;Luzhou, 646000, Sichuan, China.;Basic Medicine Research Innovation Center for Cardiometabolic Diseases, Ministry;of Education, Southwest Medical University, Luzhou, 646000, Sichuan, China.;Department of Cardiology, Peking University First Hospital, Beijing, 100034,;Department of Public Health and Preventive Medicine, School of Medicine, Jinan;University, Guangzhou, 510632, Guangdong, China.;First Department of Medicine, Faculty of Medicine, University Medical Centre;Mannheim (UMM), University of Heidelberg, Mannheim, Germany.;German Center for Cardiovascular Research (DZHK), Partner Site, Heidelberg,;Mannheim, Germany.;lijia.chang@medma.uni-heidelberg.de.;Mannheim, Germany. lijia.chang@medma.uni-heidelberg.de.;hashimoto@faculty.chiba-u.jp.;Institute of Brain Science and Brain-Inspired Research, Shandong First Medical;University & Shandong Academy of Medical Sciences, Jinan, 250117, China.;Department of Anesthesiology, Pain and Perioperative Medicine, The First;Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.;Chiba University Center for Forensic Mental Health, Chiba, 260-8670, Japan.;China. weiyan.1111@swmu.edu.cn. |
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