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.

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