Abstract
Very promising medicines in the class of brand new hypolipidemic drugs, specifically PCSK9 inhibitors, are now registered on a global scale (alirocumab was the very first medicine of this class in the world registered by an American drug agency FDA) Alirocumab, Praluent is a fully human monoclonal antibody to PCSK-9 enzyme (proprotein convertase subtilisin kexin-9). PCSK-9 enzyme plays an important role in the metabolism of LDL-cholesterol through affecting the breakdown and eventually the amount and activity of LDL-receptors.
PCSK9 inhibitors are bringing an important advancement in the treatment of disorders of lipid metabolism and in preventive cardiology. Alirocumab can be administered as monotherapy (mainly to statin-intolerant patients), however it will be primarily administered in combination with the other hypolipidemic drugs (in particular statins) where the effort to reach target values has not succeeded.
A very important group of patients indicated for treatment with Praluent will comprise patients with familial hypercholesterolemia (FH). In the modern era of evidence based medicine it is necessary to verify the effects of every new drug in controlled studies.
The presented conclusions focus on the results of the studies which verified the effects of alirocumab therapy on lipids and lipoproteins, on safety parameters and selected indicators, which suggest at least preliminary conclusions in favour of cardiovascular efficacy and safety. As our centre has its own extensive experience of conducting studies with alirocumab, the final part also considers a subjective view on the studies with this new hypolipidemic drug.