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A High-Throughput Luciferase Assay to Evaluate Proteolysis of the Single-Turnover Protease PCSK9
Published on: August 28, 2018
Effectiveness and safety of PCSK9 inhibitors in real-world clinical practice. An observational multicentre study. The
Marina Blanco-Ruiz1, Laura Amaya-Pascasio1, Reyes de Torres Chacón2
1Stroke Unit and Department of Neurology, Torrecárdenas University Hospital, Almería, Spain.
Insights
PCSK9 inhibitors alirocumab and evolocumab effectively lower LDL-cholesterol in routine practice. Their safety and efficacy align with clinical trials, showing consistent results for cardiovascular event prevention.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Research
Background:
- Pivotal trials confirmed PCSK9 inhibitors (alirocumab, evolocumab) reduce LDL-cholesterol and major adverse cardiac events (MACE).
- Limited real-world data exists comparing the efficacy and safety of alirocumab versus evolocumab in clinical practice.
Purpose of the Study:
- To analyze and compare the efficacy and safety of alirocumab and evolocumab in routine clinical practice.
- To assess LDL-cholesterol reduction and MACE occurrence in patients treated with PCSK9 inhibitors.
Main Methods:
- Retrospective observational study conducted in five hospitals in Andalusia, Spain.
- Included 141 patients treated with either alirocumab (n=90) or evolocumab (n=51).
- Collected baseline demographics, clinical data, LDL-cholesterol levels, and MACE during follow-up.
Main Results:
- Both drugs significantly reduced LDL-cholesterol by six months, sustained over time (p < 0.05).
- Greater LDL-cholesterol reduction observed in patients with established cardiovascular disease and on statin therapy.
- Nine MACEs (6.4%) occurred: 7 with alirocumab (7.8%) and 2 with evolocumab (3.9%) (p NS). Other adverse effects were mild and infrequent.
Conclusions:
- Alirocumab and evolocumab demonstrate consistent efficacy and safety in routine clinical practice.
- Real-world findings support the results observed in pivotal clinical trials for PCSK9 inhibitors.
Background And Aims:
The benefits of the PCSK9 inhibitors, alirocumab and evolocumab, in lowering LDL-cholesterol and preventing major adverse cardiac events (MACE) have been demonstrated in pivotal clinical trials. However, few studies of routine clinical practice have been conducted to analyse and compare the efficacy and safety of the two drugs.
Methods:
Retrospective observational study of patients treated with a PCSK9 inhibitor in five hospitals in Andalusia (southern Spain). Baseline demographic and clinical data, LDL-cholesterol levels and the occurrence of MACEs during the follow-up period were recorded.
Results:
A total of 141 patients were included in the study: 90 were treated with alirocumab and 51 with evolocumab. The patients' mean age (IQR) was 58 (11) years and 58 (41%) were women. The most frequent concomitant medications were statins, 94 (66.7%), followed by antiplatelet therapy (66%) and ezetimibe (65.2%). The median (IQR) follow-up period was 18 (18) months, with 18 (24) for alirocumab and 11 (18) for evolocumab. At the six-month follow-up visit, LDL-cholesterol values had decreased to pre-treatment levels and remained significantly decreased (p < 0.05) over time, for both drugs, and a greater reduction was achieved in patients with established cardiovascular disease and concomitant treatment with statins. With respect to adverse effects, there were nine MACEs (6.4%), of which seven were with alirocumab (7.8%) and two with evolocumab (3.9%) (p NS). Other adverse effects (9.2%) included local erythema (3.5%), muscle cramps (2.1%), respiratory symptoms (2.1%) and asthaenia (1.4%).
Conclusions:
The efficacy and safety of alirocumab and evolocumab in routine clinical practice are consistent with the findings of the pivotal clinical trials.
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