| アブストラクト | OBJECTIVE: To compare adverse event reporting patterns for seven Alzheimer's disease (AD) drugs (aducanumab, donanemab, lecanemab, donepezil, galantamine, rivastigmine, and memantine) using the FDA Adverse Event Reporting System (FAERS), and to explore potential reporting signals. METHODS: FAERS reports from the first quarter of 2004 to the second quarter of 2026 were retrospectively analyzed. Adverse events were coded using MedDRA version 28.1 preferred terms (PTs) and system organ classes (SOCs). Disproportionality signals were detected using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma-Poisson shrinker (MGPS). PT-level signals were additionally controlled using Benjamini-Hochberg false discovery rate correction. Drug-level comparisons, sex- and age-stratified analyses, time-to-onset (TTO) analysis, and Weibull distribution fitting were performed. RESULTS: A total of 39,301 valid reports involving the seven AD drugs were included. Reports were more frequent among women (52.3%, n = 20,537) and patients aged >/=65 years. Anti-Abeta monoclonal antibodies showed concentrated reporting signals in nervous system disorders, with amyloid related imaging abnormalities (ARIA) related events as the core PT-level signal. Donanemab and lecanemab were also associated with prominent infusion-related reaction signals. Conventional symptomatic drugs demonstrated broader multi-system reporting patterns: donepezil and galantamine were mainly associated with cholinergic cardiovascular and fall-related signals; rivastigmine with administration-site reactions and fall-related events; and memantine with confusional state, agitation, dizziness, and somnolence. Several PT-level signals were not listed in the reviewed prescribing information and were annotated as potential reporting signals. Sex- and age-stratified analyses showed broadly consistent PT-level spectra. TTO analyses revealed heterogeneous onset patterns among different drug and adverse events. CONCLUSION: This study utilized FAERS data to compare adverse event reporting signals for seven anti-AD drugs. Distinct reporting profiles were observed across drugs, and several potential ADE signals, including potential unlabeled reporting signals, were identified. These findings may support pharmacovigilance surveillance and hypothesis generation, but should be interpreted as reporting associations rather than evidence of causality. |
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| 組織名 | Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical;University, Bengbu, China.;School of Pharmacy, Bengbu Medical University, Bengbu, China.;State Key Laboratory of Neurology and Oncology Drug Development, Nanjing, China. |
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