An evaluation of alirocumab for the treatment of hypercholesterolemia. (2nd December 2015)

• Record Type: Journal Article
• Authors: Farnier, Michel
• Is Part Of: Expert review of cardiovascular therapy. Volume 13:Number 12(2015)
• Page Start: 1307
• Page End: 1323
• Publication Date: 2015-12-02
• Subjects: alirocumab -- hypercholesterolemia -- LDL-cholesterol -- PCSK9 -- cardiovascular disease; Cardiovascular agents -- Research -- Periodicals; 616.12061
• DOI: 10.1586/14779072.2015.1111759
• Languages: English
• ISSNs: 1477-9072

Abstract

Abstract : Proprotein convertase subtilisin/kexin type 9 (PCSK9) plays an important role in lipoprotein metabolism, mainly by modulating LDL receptor activity. Alirocumab is a fully human IgG1 monoclonal antibody that binds PCSK9, increases the number of LDL receptors and decreases the levels of LDL cholesterol. The efficacy of alirocumab has been evaluated in more than 6000 subjects with primary hypercholesterolemia; in Phase III trials, alirocumab consistently reduced LDL-cholesterol up to 62% with every 2 weeks dosing compared with placebo and up to 36% compared with ezetimibe. Two doses, 75 and 150 mg, have been developed to propose a tailored approach in the treatment of hypercholesterolemic patients not controlled by maximally tolerated lipid-lowering therapy. Alirocumab was generally well-tolerated, with an acceptable safety profile. The ongoing ODYSSEY OUTCOMES trial will provide definitive evidence on the effect of alirocumab on cardiovascular morbidity and mortality and complementary data on the long-term safety and tolerability. Moreover, a cost–effectiveness analysis would be useful to determine the appropriate price of alirocumab.