■多奈哌齐与美金刚的组合是用于中度至重度痴呆的广泛使用的临床疗法。然而,关于多奈哌齐联合美金刚的长期安全性的真实世界人群数据是不完整和可变的.因此,本研究的目的是根据美国食品和药物管理局不良事件报告系统(FAERS)数据分析多奈哌齐联合美金刚的不良事件(AE),为该疗法的安全性监测提供证据.
■我们回顾性分析了从FAERS数据库中提取的2004年至2023年与多奈哌齐和美金刚联合用药相关的AE报告。使用四种不成比例分析方法评估多奈哌齐和美金刚联合治疗与AE之间是否存在显着关联。即,报告的赔率比,比例报告比率,贝叶斯置信度传播神经网络,和多项目伽玛泊松收缩方法。为了进一步调查潜在的安全问题,我们还分析了按性别分层的AEs发病时间和发病率的差异和相似性,以及按年龄分层的AEs发病率的差异和相似性.
■在2,400份药物不良反应(ADR)报告中,多奈哌齐和美金刚的组合是主要的可疑药物,大多数受影响的患者为女性(54.96%),年龄大于65岁(79.08%).我们确定了22种不同的系统器官类别,涵盖100种不良事件,包括一些常见的不良事件,如头晕和心电图PR延长;跌倒,胸膜增生和肌阵鸣是未在药物标签上列出的AE.此外,我们获得了88例男性AE报告和100例女性AE报告;嗜睡是男性和女性常见的AE,在女性中更为常见,而胸膜而是男性较常见的AE。此外,我们分析了18岁以下患者的12种不良事件,16在18至65岁之间的患者中,和113在65岁以上的患者。这三个年龄组有独特的AE,但嗜睡是所有年龄组中常见的不良事件。最后,在所有病例中,AE发作的中位时间为19天.在男人和女人中,大多数不良事件发生在开始服用多奈哌齐加美金刚后的一个月内,但有些人在治疗一年后仍在继续。
■我们的研究确定了多奈哌齐联合美金刚的潜在和新的不良事件;其中一些不良事件与说明书中的相同,并且一些AE信号未在说明书中显示。此外,部分不良事件存在性别和年龄差异。因此,我们的发现可能为进一步研究多奈哌齐和美金刚联合治疗的安全性提供有价值的见解。这有望有助于该疗法在临床实践中的安全使用。
UNASSIGNED: Donepezil in combination with
memantine is a widely used clinical therapy for moderate to severe dementia. However, real-world population data on the long-term safety of donepezil in combination with
memantine are incomplete and variable. Therefore, the aim of this study was to analyze the adverse events (AEs) of donepezil in combination with
memantine according to US Food and Drug Administration Adverse Event Reporting System (FAERS) data to provide evidence for the safety monitoring of this therapy.
UNASSIGNED: We retrospectively analyzed reports of AEs associated with the combination of donepezil and memantine from 2004 to 2023 extracted from the FAERS database. Whether there was a significant association between donepezil and
memantine combination therapy and AEs was assessed using four disproportionality analysis methods, namely, the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. To further investigate potential safety issues, we also analyzed differences and similarities in the time of onset and incidence of AEs stratified by sex and differences and similarities in the incidence of AEs stratified by age.
UNASSIGNED: Of the 2,400 adverse drug reaction (ADR) reports in which the combination of donepezil and memantine was the primary suspected drug, most of the affected patients were female (54.96%) and older than 65 years of age (79.08%). We identified 22 different system organ classes covering 100 AEs, including some common AEs such as dizziness and electrocardiogram PR prolongation; fall, pleurothotonus and myoclonus were AEs that were not listed on the drug label. Moreover, we obtained 88 reports of AEs in men and 100 reports of AEs in women; somnolence was a common AE in both men and women and was more common in women, whereas pleurothotonus was a more common AE in men. In addition, we analyzed 12 AEs in patients younger than 18 years, 16 in patients between 18 and 65 years, and 113 in patients older than 65 years. The three age groups had distinctive AEs, but lethargy was the common AE among all age groups. Finally, the median time to AE onset was 19 days in all cases. In both men and women, most AEs occurred within a month of starting donepezil plus
memantine, but some continued after a year of treatment.
UNASSIGNED: Our study identified potential and new AEs of donepezil in combination with memantine; some of these AEs were the same as in the specification, and some of the AE signals were not shown in the specification. In addition, there were sex and age differences in some of the AEs. Therefore, our findings may provide valuable insights for further studies on the safety of donepezil and memantine combination therapy, which are expected to contribute to the safe use of this therapy in clinical practice.