Real-World Effectiveness and Safety of Inclisiran Monotherapy in Chinese Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia

Background: Inclisiran, a small interfering RNA (siRNA) that inhibits proprotein convertase subtilisin/kexin type 9 synthesis, has demonstrated significant lipid-lowering efficacy and an acceptable safety profile in clinical trials.However, real-world evidence in Chinese populations remains limited.This study evaluated the effectiveness and safety of inclisiran in Chinese patients with primary hypercholesterolemia or mixed dyslipidemia requiring primary prevention.Methods: This multicenter, retrospective, real-world observational study included adult patients (n=126) who received inclisiran monotherapy at United Family Healthcare hospitals and clinics across several Chinese cities between October 2023 and March 2025.Based on prior lipid-lowering treatment history, patients were classified into an inclisiran-naïve group (n=95) and a statin-to-inclisiran switch group (n=31).The primary endpoint was the percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to 3 months.Secondary endpoints included changes in other lipid parameters and liver function.Results: At 3 months, mean LDL-C decreased by 40.3% from baseline (p <0.001), with reductions of 41.9% in the inclisiran-naïve group and 36.4% in the switch group (both p <0.001).Total cholesterol decreased by 27.1%, from 6.26 to 4.40 mmol/L, and non-high-density lipoprotein (HDL) cholesterol decreased by 34.2%, from 4.84 to 2.96 mmol/L (both p<0.001).No clinically relevant liver function abnormalities were observed. Conclusion:In this real-world study, inclisiran monotherapy produced substantial reductions in LDL-C levels without clinically relevant liver function abnormalities during the 3-month follow-up.These findings support inclisiran as a feasible primary prevention option for Chinese patients with primary hypercholesterolemia or mixed dyslipidemia.