| アブストラクト | BACKGROUND: Sacubitrilvalsartan is widely used in the clinical management of heart failure with reduced ejection fraction and hypertension. This study aims to systematically investigate and quantify the safety signals and potential risks associated with sacubitrilvalsartan in individuals aged 65 and older, leveraging data from the FAERS database to provide insights into its real-world safety profile. METHODS: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed to quantify the signals of Sacubitrilvalsartan-associated AEs in elderly. RESULTS: The search retrieved 94,210 sacubitrilvalsartan-associated cases within the reporting period; 86 PTs with significant disproportionality were retained in 65 + . Reports emerged for several cognitive-related AEs and several fragility acceleration AEs, which were rare. Unexpected safety signals such as 'Injury, poisoning, and procedural complications' were only detected in 65 + . Most of the cases occurred within the first month after sacubitrilvalsartan initiation, and this was consistent across age groups. CONCLUSIONS: Our study found potential new AEs signals and might provide important support for clinical monitoring and risk identification of Sacubitrilvalsartan in elderly. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/2/7 |
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| 投稿者 | Kuai, Zheng; Li, Quan; Zhang, Xiaoyi; Tang, Guowen; Ye, Yangli; Hu, Yu |
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| 組織名 | Department of Geriatrics, Zhongshan Hospital, Fudan University, Shanghai, China.;Department of Echocardiography, Zhongshan Hospital, Shanghai Institute of;Cardiovascular Diseases, Shanghai Institute of Medical Imaging, Fudan University,;Shanghai, China.;Center for Evidence Based Medicine and Clinical Epidemiology, Zhongshan Hospital,;Fudan University, Shanghai 200032, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39916346/ |
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