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Updated: Sep 10, 2026

Cholesterol Efflux Assay
Published on: March 6, 2012
Alirocumab for the treatment of hypercholesterolaemia
Giuseppe Della Pepa1, Lutgarda Bozzetto1, Giovanni Annuzzi1
1a Department of Clinical Medicine and Surgery , Federico II University , Naples , Italy.
Insights
Alirocumab, a PCSK9 inhibitor, effectively lowers LDL cholesterol in patients unable to reach targets with statins. Further long-term data are needed to confirm cardiovascular outcome benefits.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Biochemistry
Background:
- Statins are standard for LDL-C reduction but many patients fail to reach targets.
- Novel therapies are needed for hypercholesterolemia management.
- Alirocumab is a monoclonal antibody targeting PCSK9, approved for hypercholesterolemia.
Purpose of the Study:
- To review the pharmacological features, clinical efficacy, and safety of alirocumab.
- To discuss therapeutic perspectives of alirocumab based on recent clinical trials.
Main Methods:
- Review of pharmacological data.
- Analysis of clinical trial results on alirocumab efficacy and safety.
- Discussion of therapeutic applications and future research directions.
Main Results:
- Alirocumab significantly reduces LDL-C levels.
- The drug demonstrates good safety and tolerability.
- It is a promising option for statin-intolerant patients or those with high LDL-C despite maximal statin therapy.
Conclusions:
- Alirocumab offers a valuable therapeutic option for managing hypercholesterolemia.
- Long-term data on safety and cardiovascular outcomes are essential for comprehensive evaluation.
Introduction:
Prescription of statins for low-density lipoprotein cholesterol (LDL-C) reduction is the standard of care in primary and secondary prevention of cardiovascular disease; nevertheless, a large number of patients treated with statins are unable to reach the recommended LDL-C targets. Therefore, there is need for safe and effective novel therapies for the pharmacological management of hypercholesterolaemia, in addition or as alternative to lipid-lowering therapies (LLT) currently in use. Areas covered: In 2015, the Food and Drug Administration and the European Medicines Agency approved alirocumab (Praluent®; Sanofi), a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), for the treatment of hypercholesterolaemic patients unable to meet LDL-C targets, as an adjunct to diet in addition/alternative to LLT. The authors review the pharmacological features, clinical efficacy, and safety of alirocumab in lowering LDL-C, and discuss its therapeutic perspectives based on the most recent clinical trials. Expert commentary: Alirocumab causes a marked reduction in LDL-C, presents good safety and tolerability, and represents a promising approach for LDL-C lowering, particularly in patients with intolerance to statin or elevated LDL-C despite maximal statin therapy; nevertheless, further long-term data on safety and efficacy are necessary, such as data on the improvement of cardiovascular outcomes.
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