| アブストラクト | BACKGROUND: Recent studies suggest histamine H1 receptor antagonists (H1RAs) may elevate broad dementia events risk, though real-world data remain scarce. METHODS: This pharmacovigilance study analyzed FDA Adverse Event Reporting System (FAERS), Japanese Adverse Drug Event Report (JADER), and Canada Vigilance Adverse Reaction (CVAR) databases from January 2004 to June 2024. Using disproportionality analyses such as the reporting odds ratio (ROR) and proportion reporting ratio (PRR), time-to-onset analysis, propensity score matching, and multivariate regression, we compared broad dementia event signals among first-generation H1RAs (FG-H1RAs), second-generation H1RAs (SG-H1RAs), and benzodiazepines (BDs). RESULTS: According to the FAERS database, FG-H1RAs (ROR = 3.33, 95%CI 3.22-3.44; PRR = 3.11, chi2 = 5426.01), SG-H1RAs (ROR = 2.03, 95%CI 1.98-2.07; PRR = 1.97, chi2 = 3706.58), and BDs (ROR = 2.74, 95%CI 2.68-2.80; PRR = 2.6, chi2 = 8338.34) were significantly associated with broad dementia events, with FG-H1RAs having a stronger association with broad dementia events compared to SG-H1RAs (aROR = 0.60, 95%CI 0.54-0.67, p < 0.001). Analysis of the JADER and CVAR databases yielded similar results. FG-H1RAs exhibited immediate broad dementia events reporting (median = 0 days), while SG-H1RAs showed delayed onset (median = 1 day), both with early risk decay. CONCLUSION: This study provides evidence for the association between H1RAs treatment and broad dementia events, highlighting signaling differences among H1RAs. However, large-scale, high-quality epidemiological studies are still needed for validation. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/6/12 |
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| 投稿者 | Kan, Jingjing; Chen, Yechao; Gu, Qiaoling; Hu, Na; Qiao, Yanli; Chen, Yawen; Chen, Dayu; Zhang, Haixia |
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| 組織名 | Department of Pharmacy, Nanjing Drum Tower Hospital, School of Basic Medicine and;Clinical Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu, China.;Department of Pharmacy, Nanjing Drum Tower Hospital, Nanjing Drum Tower Hospital;Clinical College of Nanjing University of Chinese Medicine, Nanjing, Jiangsu,;China.;Department of Pharmacy, Nanjing Drum Tower Hospital, Affiliated Hospital of;Medical School, Nanjing University, Nanjing, Jiangsu, China.;School of Pharmacy, Faculty of Medicine, Macau University of Science and;Technology, Macau, SAR, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40501012/ |
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