Signal mining and analysis of gender distribution of adverse events of PCSK9 inhibitors based on the FAERS database
10.12173/j.issn.1005-0698.202411085
- VernacularTitle:基于FAERS数据库的PCSK9抑制剂不良事件性别差异信号挖掘与分析
- Author:
Lan WANG
1
;
Zhujun ZENG
;
Yuan BIAN
Author Information
1. 成都市金牛区人民医院西药剂科(成都 610036)
- Publication Type:Journal Article
- Keywords:
PCSK9 inhibitor;
Signal mining;
Gender distribution;
Adverse drug events
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(10):1169-1177
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the gender distribution of adverse drug event(ADE)signals of proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitors(alirocumab,evolocumab and inclisiran),and to provide reference for individualized safe medication in different genders.Methods The reports of the drugs mentioned above from the first quarter of 2022 to the first quarter of 2024 were extracted from the U.S.Food and Drug Administration Adverse Events Reporting System(FAERS)database.The reporting odds ratio(ROR)method and composite criteria method from Medicines and Healthcare Products Regulatory Agency were used to mine and analyse the signals.Results All 3 PCSK9 inhibitors had more reported cases of ADE in women than in men,and a greater proportion of elderly patients in women relative to men.Signal testing revealed that men were more likely to have injection sites-related ADEs with alirocumab,and muscle-related ADEs and elevated lipoprotein a with inclisiran.While for women,using alirocumab or evolocumab was more likely to cause cardiovascular adverse events,and using inclisiran was more likely to cause a decrease in low-density lipoprotein or in triglycerides.Conclusion There are gender-specific differences in the ADE signals of PCSK9 inhibitors.Clinical use can refer to the signals of high-risk ADEs that may occur after drug use by different genders,targeting the identification of adverse drug events and exploring the possibility of gender-individualized treatment.
