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使用日本药品不良事件报告数据库分析胆碱酯酶抑制剂和NMDA受体拮抗剂对心律失常的不良事件

Analysis of Adverse Events of Cholinesterase Inhibitors and NMDA Receptor Antagonists on Arrhythmias Using the Japanese Adverse Drug Event Report Database.

作者信息

Kobayashi Shotaro, Sugama Norio, Nagano Hiroyuki, Miyamori Ayaka, Takahashi Masahiro, Kushiyama Akifumi

机构信息

Department of Pharmacy, Sonoda Daiichi Hospital, Tokyo, Japan.

Department of Pharmacotherapy, Meiji Pharmaceutical University, Kiyose, Tokyo, 204-8588, Japan.

出版信息

Drugs Real World Outcomes. 2023 Jun;10(2):321-329. doi: 10.1007/s40801-023-00362-6. Epub 2023 Apr 22.

Abstract

BACKGROUND

The association between anti-dementia drugs and arrhythmia is uncertain. In addition, the effects of certain drug combinations are not yet well known.

OBJECTIVE

We investigated the association between anti-dementia drugs and arrhythmia. Furthermore, we investigated the effects of anti-dementia drugs both alone and in combination on the likelihood of arrhythmia in patients with dementia.

METHODS

We examined the Japanese Adverse Drug Event Report database (JADER) from April 2004 to May 2022 for dementia drug users aged ≥ 60 years. We calculated the unadjusted reported odds ratio (ROR) and adjusted ROR for confounding factors. Furthermore, we examined the association of various combinations of anti-dementia drugs with the development of arrhythmias.

RESULTS

There were 6718 arrhythmia cases identified out of 333,702 reported cases. The unadjusted ROR results were as follows: donepezil alone (ROR 4.39, 95% confidence interval [CI] 3.89-4.95), rivastigmine alone (2.10, 1.53-2.87), galantamine alone (3.87, 3.04-4.94), memantine alone (2.25, 1.59-3.20), and combination of choline esterase inhibitor and memantine (2.56, 1.84-3.57). In a multivariate analysis, the RORs remained significant.

CONCLUSIONS

Regardless of whether anti-dementia drugs were used alone or in combination, attention should be paid to the occurrence of arrhythmias.

摘要

背景

抗痴呆药物与心律失常之间的关联尚不确定。此外,某些药物组合的效果尚不明确。

目的

我们研究了抗痴呆药物与心律失常之间的关联。此外,我们还研究了抗痴呆药物单独使用以及联合使用对痴呆患者发生心律失常可能性的影响。

方法

我们查阅了2004年4月至2022年5月的日本药品不良反应报告数据库(JADER),纳入年龄≥60岁的痴呆药物使用者。我们计算了未调整的报告比值比(ROR)以及针对混杂因素调整后的ROR。此外,我们还研究了各种抗痴呆药物组合与心律失常发生之间的关联。

结果

在333,702例报告病例中,共识别出6718例心律失常病例。未调整的ROR结果如下:多奈哌齐单药治疗(ROR 4.39,95%置信区间[CI] 3.89 - 4.95),卡巴拉汀单药治疗(2.10,1.53 - 2.87),加兰他敏单药治疗(3.87,3.04 - 4.94),美金刚单药治疗(2.25,1.59 - 3.20),胆碱酯酶抑制剂与美金刚联合治疗(2.56,1.84 - 3.57)。在多变量分析中,ROR仍具有显著性。

结论

无论抗痴呆药物是单独使用还是联合使用,都应关注心律失常的发生。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/056e/10232399/aec89407c8f4/40801_2023_362_Fig1_HTML.jpg

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