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Updated: Jun 13, 2025
A High-Throughput Luciferase Assay to Evaluate Proteolysis of the Single-Turnover Protease PCSK9
Published on: August 28, 2018
PCSK9 inhibitors on the management of primary and secondary cardiovascular prevention
Victoria Marco-Benedí1,2, Rosa M Sánchez-Hernández3, José Luis Díaz4
1Hospital Universitario Miguel Servet, IIS Aragón, CIBERCV, Saragossa, Spain. vmarcobenedi@gmail.com.
Insights
Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are underutilized in hypercholesterolemia management. Study found PCSK9i use focused on baseline LDLc, with lower prescription rates in women, particularly for secondary prevention.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represent a significant advancement in hypercholesterolemia treatment.
- Many patients with atherosclerotic cardiovascular disease (CVD) or at high risk do not achieve therapeutic LDL-C goals without PCSK9i.
Purpose of the Study:
- To analyze the clinical and biochemical characteristics of patients treated with PCSK9i.
- To evaluate PCSK9i utilization within the Dyslipidemia Registry of the Spanish Atherosclerosis Society.
Main Methods:
- Analysis of consecutive patients aged ≥18 years from the Dyslipidemia Registry of the SEA.
- Inclusion criteria: hypercholesterolemia (LDL-C ≥130 mg/dL or non-HDL-C ≥160 mg/dL) and ≥2 years of follow-up.
- Comparison of baseline and final characteristics based on primary/secondary prevention and PCSK9i use.
Main Results:
- 12.1% of patients (500/4127) were on PCSK9i at follow-up end; 35.6% of CVD patients used PCSK9i.
- PCSK9i use correlated with age, baseline LDLc, and DLCN score, not hypertension, diabetes, or smoking.
- PCSK9i users achieved significant LDLc reductions (75.1%-80.3%); men with CVD received PCSK9i more than women.
Conclusions:
- PCSK9i prescription was primarily driven by baseline LDLc levels rather than overall CVD risk.
- Women, particularly in secondary prevention, were prescribed PCSK9i less frequently than men.
- Further research is needed to understand and address disparities in PCSK9i utilization.
Background:
Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) have represented an important change in the management of hypercholesterolemia, although, until now, they have barely been used. Without PCSK9i, many patients with atherosclerotic cardiovascular disease (CVD) or those at very high risk do not reach their therapeutic LDLc objectives.
Objective:
The analysis aimed to examine the clinical and biochemical characteristics of subjects receiving PCSK9i treatment in the Dyslipidemia Registry of the Spanish Atherosclerosis Society.
Methods:
All consecutive subjects aged ≥ 18 years from different Lipid Units included in the Dyslipidemia Registry of the SEA were analyzed. Inclusion criteria consisted of unrelated patients aged ≥ 18 at the time of inclusion with hypercholesterolemia (LDL-C ≥ 130 mg/dL or non-HDL-C ≥ 160 mg/dL after the exclusion of secondary causes) who were studied for at least two years after inclusion. Participants' baseline and final visit clinical and biochemical characteristics were analyzed based on whether they were on primary or secondary prevention and whether they were taking PCSK9i at the end of follow-up.
Results:
Eight hundred twenty-nine patients were analyzed, 7014 patients in primary prevention and 1281 in secondary prevention at baseline. 4127 subjects completed the required follow-up for the final analysis. The median follow-up duration was 7 years (IQR 3.0-10.0). Five hundred patients (12.1%) were taking PCSK9i at the end of the follow-up. The percentage of PCSK9i use reached 35.6% (n = 201) and 8.7% (n = 318) in subjects with and without CVD, respectively. Subjects on PCSK9i and oral lipid-lowering agents with and without CVD achieved LDLc reductions of 80.3% and 75.1%, respectively, concerning concentrations without lipid-lowering drugs. Factors associated with PCSK9i use included increasing age, LDLc without lipid-lowering drugs and the Dutch Lipid Clinic Network (DLCN) score. However, hypertension, diabetes, smoking, and LDLc after oral lipid-lowering drugs were not independent factors associated with PCSK9i prescription. In subjects with CVD, the use of PCSK9i was higher in men than in women (an odds ratio of 1.613, P = 0.048).
Conclusions:
Approximately one-third of CVD patients received PCSK9i at the end of follow-up. The use of PCSK9i was more focused on baseline LDLc concentrations rather than on CVD risk. Women received less PCSK9i in secondary prevention compared to men.
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