Alirocumab for the treatment of hypercholesterolaemia. Issue 6 (3rd June 2017)

• Record Type: Journal Article
• Authors: Della Pepa, Giuseppe; Bozzetto, Lutgarda; Annuzzi, Giovanni; Rivellese, Angela Albarosa
• Is Part Of: Expert review of clinical pharmacology. Volume 10:Issue 6(2017)
• Page Start: 571
• Page End: 582
• Publication Date: 2017-06-03
• Subjects: Alirocumab -- LDL-cholesterol -- hypercholesterolaemia -- PCSK9 -- monoclonal antibody; Clinical pharmacology -- Periodicals; 615.105
• DOI: 10.1080/17512433.2017.1318063
• Languages: English
• ISSNs: 1751-2433

Abstract

ABSTRACT: 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.