Analysis of the risk of neurocognitive adverse events caused by evolocumab and alirocumab
- VernacularTitle: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
- Author:
Qian GUO
1
;
Hui GUO
2
;
Donghong YIN
1
Author Information
1. Dept. of Pharmacy，Second Hospital of Shanxi Medical University，Taiyuan 030001，China
2. Dept. of Pharmacy，Shanxi Cardiovascular Hospital，Taiyuan 030024，China
- Publication Type:Journal Article
- Keywords:
evolocumab;
alirocumab;
neurocognition;
FDA adverse event reporting system;
reported odds ratio
- From:
China Pharmacy
2022;33(19):2393-2397
- CountryChina
- Language:Chinese
-
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 .
