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成人因多奈哌齐引起的心动过缓:FDA 不良事件报告系统的系统分析。

Bradycardia Due to Donepezil in Adults: Systematic Analysis of FDA Adverse Event Reporting System.

机构信息

Department of Pharmaceutical Science, Taneja College of Pharmacy, University of South Florida, Tampa, FL, USA.

Muma College of Business, University of South Florida, Tampa, FL, USA.

出版信息

J Alzheimers Dis. 2021;81(1):297-307. doi: 10.3233/JAD-201551.

DOI:10.3233/JAD-201551
PMID:33780370
Abstract

BACKGROUND

Bradycardia is a physiological condition characterized by a decrease in heart rate and is a side effect of many drug classes. Bradycardia has been reported as an adverse event for patients receiving donepezil for Alzheimer's disease (AD) treatment.

OBJECTIVE

The purpose of the paper is to systematically investigate the association between the occurrence of bradycardia in adults and the usage of donepezil using clinical data derived from the FDA Adverse Event Reporting System (FAERS) database.

METHODS

The risk of bradycardia in patients who only took donepezil was compared with those of patients who only took over-the-counter medications, multiple arrhythmia drugs, or other medications for AD treatment. In addition, this study sought to determine if this heightened bradycardia risk was influenced by sex, age, and dosage.

RESULTS

The results indicated that there was a significant greater likelihood of reporting bradycardia in patients administered donepezil than most of the drugs investigated. There was no significant association between age or the dosage of donepezil and the likelihood of reporting bradycardia. However, males were found to be more likely than females to report bradycardia as an adverse event. Tumor necrosis factor inhibition and the stimulation of endothelial nitric oxide synthase were proposed to be the primary mechanism of actions which confer elevated bradycardia risk when using donepezil.

CONCLUSION

These findings identified strong association between the usage of donepezil and bradycardia in adults as well as provided insight into the underlying molecular mechanisms that induce bradycardia by donepezil.

摘要

背景

心动过缓是一种心率降低的生理状态,是许多药物类别的副作用。已经报道接受多奈哌齐治疗阿尔茨海默病(AD)的患者出现心动过缓作为不良反应。

目的

本文旨在使用来自 FDA 不良事件报告系统(FAERS)数据库的临床数据,系统地调查成人心动过缓与多奈哌齐使用之间的关联。

方法

将仅服用多奈哌齐的患者发生心动过缓的风险与仅服用非处方药、多种心律失常药物或其他用于 AD 治疗的药物的患者进行比较。此外,本研究试图确定这种心动过缓风险增加是否受性别、年龄和剂量的影响。

结果

结果表明,与大多数研究药物相比,接受多奈哌齐治疗的患者报告心动过缓的可能性显著更高。多奈哌齐的年龄或剂量与报告心动过缓的可能性之间没有显著关联。然而,男性比女性更有可能报告心动过缓作为不良反应。肿瘤坏死因子抑制和内皮型一氧化氮合酶的刺激被认为是使用多奈哌齐时导致心动过缓风险增加的主要作用机制。

结论

这些发现确定了多奈哌齐在成人中的使用与心动过缓之间的强烈关联,并深入了解了多奈哌齐引起心动过缓的潜在分子机制。

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