Analysis of the risk of neurocognitive adverse events caused by evolocumab and alirocumab

GUO Qian; GUO Hui; YIN Donghong

doi:10.6039/j.issn.1001-0408.2022.19.18

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Analysis of the risk of neurocognitive adverse events caused by evolocumab and alirocumab

更新时间：2025-12-03

- Analysis of the risk of neurocognitive adverse events caused by evolocumab and alirocumab
- ZHONGGUO YAOFANG Vol. 33, Issue 19, Pages: 2393-2397(2022)
- 作者机构：
  
  1.山西医科大学第二医院药学部，太原　030001
  2.山西省心血管病医院药学部，太原　030024
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2022.19.18
  CLC： R969.3
- Received：10 March 2022，
  
  Revised：2022-07-26，
  
  Published：15 October 2022
- 稿件说明：
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郭茜,郭慧,尹冬虹.依洛尤单抗和阿利西尤单抗致神经认知不良事件的风险分析^Δ[J].中国药房,2022,33(19):2393-2397.

GUO Qian,GUO Hui,YIN Donghong.Analysis of the risk of neurocognitive adverse events caused by evolocumab and alirocumab[J].ZHONGGUO YAOFANG,2022,33(19):2393-2397.
郭茜,郭慧,尹冬虹.依洛尤单抗和阿利西尤单抗致神经认知不良事件的风险分析^Δ[J].中国药房,2022,33(19):2393-2397. DOI： 10.6039/j.issn.1001-0408.2022.19.18.

GUO Qian,GUO Hui,YIN Donghong.Analysis of the risk of neurocognitive adverse events caused by evolocumab and alirocumab[J].ZHONGGUO YAOFANG,2022,33(19):2393-2397. DOI： 10.6039/j.issn.1001-0408.2022.19.18.

摘要

目的

对依洛尤单抗和阿利西尤单抗致神经认知的不良事件报告进行分析，为临床安全用药提供参考。

方法

提取2015年7月1日至2020年9月30日美国FDA不良事件报告系统（FAERS）中依洛尤单抗和阿利西尤单抗的神经认知不良事件报告，神经认知不良事件使用高位组语进行识别。采用报告比值比（ROR）法，根据报告数≥3且ROR的95%置信区间（95%CI）下限＞1的设定，评价以上2种药物与神经认知障碍的相关性。

结果

分别获得依洛尤单抗和阿利西尤单抗不良事件报告71 849份和13 171份，其中神经认知不良事件报告分别为1 425份（1.98%）和405份（3.07%）。依洛尤单抗、阿利西尤单抗致神经认知不良事件的ROR（95%CI）分别为0.610（0.579，0.643）、0.931（0.844，1.028）。依洛尤单抗筛选出1个信号（记忆障碍），阿利西尤单抗筛选出3个信号（记忆障碍、健忘症、认知障碍）。

结论

依洛尤单抗和阿利西尤单抗与神经认知不良事件无相关性。

Abstract

OBJECTIVE

To analyze the reports of neurocognitive adverse events caused by evolocumab and alirocumab， so as to provide reference for clinical safe drug use.

METHODS

From July 1， 2015 to September 30， 2020， the neurocognitive adverse event reports of evolocumab and alirocumab in the FDA adverse event reporting system （FAERS） were extracted， and the neurocognitive adverse events were identified using high-level phrases. The reported odds ratio （ROR） method was used to evaluate the correlation between the above two drugs and neurocognitive impairment according to the setting of the number of reports ≥3 and the lower limit of the 95% confidence interval （95%CI） of ROR ＞1.

RESULTS

Totally 71 849 and 13 171 reports of adverse events were obtained for evolocumab and alirocumab respectively， of which 1 425 （1.98%） and 405 （3.07%） were reported for neurocognitive adverse events. ROR（95%CI） of neurocognitive adverse events caused by evolocumab and alirocumab were 0.610 （0.579， 0.643） and 0.931 （0.844， 1.028）， respectively. One signal （memory impairment） was screened by evolocumab， and three signals （memory impairment， amnesia and cognitive impairment） were screened by alirocumab.

CONCLUSIONS

There is no risk of neurocognitive impairment in patients receiving evolocumab and alicizumab.

关键词

Keywords

references

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