Objective To evaluate the efficacy and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors combined with high-intensity statins in the treatment of hypercholesterolemia.

Methods A retrospective study was conducted on patients diagnosed with hypercholesterolemia at the First Affiliated Hospital of Zhengzhou University from June 2023 to December 2024. Patients were divided into an observation group (receiving alirocumab combined with atorvastatin) and a control group (receiving atorvastatin alone) based on their actual treatment regimens. The treatment period was 6 months. Primary outcome measures included lipid parameters such as low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apoB), and lipoprotein (a), (Lpa); carotid ultrasound parameters such as intima-media thickness (IMT), plaque number, plaque area; and inflammatory markers including high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumour necrosis factor-α (TNF-α). Adverse reactions were also recorded.

Results A total of 103 patients with hypercholesterolemia were included, with 53 in the observation group and 50 in the control group. After six months of treatment, the observation group demonstrated significantly greater reductions in LDL-C, total cholesterol (TC), triglyceride (TG), and apoB compared to the control group (P ＜ 0.05). The reduction in plaque count and plaque area were also significantly greater in the observation group than in the control group (P＝0.004). The reduction in TNF-α was also greater in the observation group (P＝0.006). There was no statistically significant difference in the incidence of adverse reactions between the two groups.

Conclusions PCSK9 inhibitors combined with high-intensity statins can effectively reduce LDL-C levels, improve carotid atherosclerotic plaques and systemic inflammatory status in patients with hypercholesterolemia, and demonstrate good safety in real-world clinical settings.