Proprotein convertase subtilisin/kexin type 9: an update on the cardiovascular outcome studies

Inhibitors of the 3-hydroxy-3-methylglutaryl coenzyme A reductase enzyme, statins, are powerful cholesterol-lowering medications and have provided outstanding contributions to the primary and secondary prevention of coronary heart disease. Low-density lipoprotein cholesterol (LDL-C) is one of the major modifiable cardiovascular risk factors, indeed, every 1.0 mmol/L (38.7 mg/dL) reduction in LDL cholesterolaemia corresponds to a 21% lowering in the risk of major vascular events. In this context, the pharmacological approach with PCSK9 monoclonal antibodies is considered a promising non-statin therapeutic option for the management of lipid disorders in patients with persistent cardiovascular risk, including patients with diabetes mellitus. Data from two large clinical trials have indisputably demonstrated the efficacy of alirocumab and evolocumab in preventive major adverse cardiovascular events in high risk, secondary-prevention patients with clinical manifestation of atherosclerotic cardiovascular diseases. Finally, PCSK9 monoclonal antibodies did not increase the risk of serious adverse events, neurocognitive events, new-onset of diabetes, muscle-related events, or myalgia.