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A High-Throughput Luciferase Assay to Evaluate Proteolysis of the Single-Turnover Protease PCSK9
Published on: August 28, 2018
Efficacy, safety, adherence and persistence of PCSK9 inhibitors in clinical practice: A single country, multicenter,
Paola Gargiulo1, Christian Basile1, Arturo Cesaro2
1Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
Insights
Proprotein Convertase Subtilisin/Kexin type 9 inhibitors (PCSK9i) demonstrate high effectiveness and adherence in real-world cardiovascular risk management. This Italian registry shows PCSK9i therapy achieves LDL-cholesterol goals in most patients, with excellent persistence rates.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Proprotein Convertase Subtilisin/Kexin type 9 inhibitors (PCSK9i) are recommended for high cardiovascular (CV) risk patients.
- Real-world data on PCSK9i use in clinical practice are limited.
- The AT-TARGET-IT registry was established to evaluate PCSK9i in Italian clinical practice.
Purpose of the Study:
- To assess the real-world effectiveness of PCSK9 inhibitors in Italian patients.
- To evaluate adherence and persistence to PCSK9 inhibitor therapy.
- To determine the achievement of LDL-cholesterol targets in patients treated with PCSK9 inhibitors.
Main Methods:
- An observational, multicenter registry (AT-TARGET-IT) was conducted in Italy.
- Data were collected at the time of the first PCSK9i prescription and at the latest observation.
- 798 patients were enrolled and followed for adherence, persistence, and LDL-C levels.
Main Results:
- A median 64.9% reduction in LDL-C levels was observed.
- 63.8% of patients achieved their LDL-C target.
- High adherence (95.2%) and persistence (97.5% at 18 months) were recorded, with low discontinuation rates (3.5%).
Conclusions:
- PCSK9 inhibitors are safe and effective in clinical practice.
- High adherence and persistence rates support the long-term use of PCSK9i.
- PCSK9i therapy, particularly in combination, helps achieve recommended LDL-C targets for cardiovascular risk reduction.
Background And Aims:
Proprotein Convertase Subtilisin/Kexin type 9 inhibitors (PCSK9i) are recommended in patients at high and very-high cardiovascular (CV) risk, with documented atherosclerotic CV disease (ASCVD), and for very-high risk patients with familial hypercholesterolaemia not achieving LDL-cholesterol (LDL-C) goal while receiving maximally tolerated dose of lipid-lowering therapy (LLT). However, single country real-life data, reporting the use of PCSK9i in clinical practice, are limited. Therefore, we designed AT-TARGET-IT, an Italian, multicenter, observational registry on the use of PCSK9i in clinical practice.
Methods:
All data were recorded at the time of the first prescription and at the latest observation preceding inclusion in the study.
Results:
798 patients were enrolled. The median reduction in LDL-C levels was 64.9%. After stratification for CV risk, 63.8% achieved LDL-C target; of them, 83.3% took LLTs at PCSK9i initiation and 16.7% did not. 760 patients (95.2%) showed high adherence to therapy, 13 (1.6%) partial adherence, and 25 (3.1%) poor adherence. At 6 months, 99.7% of patients enrolled in the study remained on therapy; there were 519 and 423 patients in the study with a follow-up of at least 12 and 18 months, respectively. Persistence in these groups was 98.1% and 97.5%, respectively. Overall, 3.5% of patients discontinued therapy. No differences in efficacy, adherence, and persistence were found between alirocumab and evolocumab.
Conclusions:
PCSK9i are safe and effective in clinical practice, leading to very high adherence and persistence to therapy, and achievement of recommended LDL-C target in most patients, especially when used as combination therapy.
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