(186) Real-World Patient Profiles and Lipid-Lowering Efficacy of PCSK9 Inhibitors

Background: Clinical trials have provided evidence that Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) inhibitors are effective in significantly lowering lipid levels and reducing the risk of major adverse cardiovascular events. However, there is a scarcity of evidence on the real-world efficacy and utilization of PCSK9 inhibitors.

Objectives: To examine the patient characteristics of new PCSK9 inhibitor users and their lipid goal achievement in routine clinical settings.

Methods: We identified 4,701 new PCSK9 inhibitor users (alirocumab: 2,365; evolocumab: 2,232; inclisiran: 104) through electronic health records from the Hospital Authority of Hong Kong from 2016 to 2023 and The Hong Kong University - Shenzhen Hospital from 2020 to 2023. We collected data on user demographics, comorbidities, cardiovascular drugs, lipid tests and the occurrence of major adverse cardiac and cerebrovascular events (MACCE). Continuous data were reported as medians and (interquartile range) IQR; categorical data as counts and percentages. We synthesized the results of two sources.

Results: Median age was 60; 70% were male. High prevalence of cardiovascular conditions included hyperlipidaemia (60%), ischemic heart disease (66%), and stroke (23.3%). Concerning PCSK9 inhibitor use, 70.2% (n=3300) were on combination therapy. Following PCSK9 inhibitor initiation, MACCE occurred in 10% (n=468) of patients, which included all-cause mortality at 0.8% (n=39), myocardial infarction at 2.0% (n=94), stroke at 2.2% (n=103), and heart failure at 5.6% (n=265). Lipid tests revealed a decrease in total cholesterol from a median of 4.72 mmol/L (IQR: 3.85-5.92) to 3.12 mmol/L (IQR: 2.42-4.13), an increase in HDL-C from 1.19 mmol/L (IQR: 1.00-1.44) to 1.24 mmol/L (IQR: 1.03-1.49), and a reduction in triglycerides from 1.43 mmol/L (IQR: 0.99-2.13) to 1.23 mmol/L (IQR: 0.85-1.83). LDL-C levels also decreased significantly from 2.93 mmol/L (IQR: 2.15-3.97) to 1.36 mmol/L (IQR: 0.78-2.22), reaching the lowest median value of 0.93 mmol/L (IQR: 0.52-1.54). Notably, over half of the patients (54.2%) achieved a ≥50% reduction in LDL-C. Attainment of specific LDL-C treatment goals post-PCSK9 inhibitor treatment was as follows: 81.6% (n=3222) reached an LDL-C level of < 2.6 mmol/L, 64.7% (n=2554) achieved < 1.8 mmol/L and 51.3% (n=2025) attained < 1.4 mmol/L. Evolocumab demonstrated potentially superior lipid-lowering efficacy, with 58.2% of its users achieving a ≥50% reduction in LDL-C, exceeding alirocumab at 50.6% and inclisiran at 41.5%.

Conclusions: This study provides real-world insights into PCSK9 inhibitors' user profiles and their lipid-lowering effectiveness in clinical practice, demonstrating their significant potential in achieving LDL-C treatment targets.