Mining adverse event signals of PCSK9 inhibitors based on FAERS database
10.16753/j.cnki.1008-2344.2025.04.011
- VernacularTitle:基于FAERS数据库对PCSK9抑制剂不良事件信号挖掘
- Author:
Ying CHEN
1
;
Gang CHENG
Author Information
1. 沈阳药科大学生命科学与生物制药学院,辽宁 沈阳 110016;沈阳医学院附属第二医院药剂科
- Publication Type:Journal Article
- Keywords:
evolocumab;
alirocumab;
FAERS database;
adverse reactions;
signal mining
- From:
Journal of Shenyang Medical College
2025;27(4):396-401,423
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine adverse event signals of PCSK9 inhibitors(evolocumab and alirocumab)from the FAERS database,providing a scientific basis for rational clinical drug use.Methods:Openvigil 2.1 was used to extract adverse event reports for evolocumab and alirocumab from the FAERS database from the third quarter of 2015 to the second quarter of 2024.The combined analysis of proportional reporting ratio(PRR)and reporting odds ratio(ROR)was utilized to deeply excavate and assess adverse events.Results:A total of 153 177 adverse event reports were collected,comprising 137 983 for evolocumab and 15 194 for alirocumab.The incidence of adverse events for both drugs was higher in female patients than in male patients.Patients aged 65-84 years had the highest proportion of adverse events,followed by those aged 45-64 years.Among serious adverse events,hospitalization or prolonged hospitalization accounted for the highest proportion of reported outcomes.A total of 57 adverse event signals for evolocumab and 98 for alirocumab were identified through PRR and ROR methods.All adverse event signals of the two drugs involved 18 organ systems,with the top three being"General diseases and various reactions at the administration site","Various muscle,bone and connective tissue diseases"and"Diseases of the respiratory system,chest and mediastinum".Conclusion:When applying evolocumab and alirocumab in clinical practice,in addition to paying attention to the adverse reactions listed in the drug instructions,potential adverse reactions not mentioned in the instructions should also be taken into consideration to ensure the safety of clinical medication.
