Atherosclerotic cardiovascular diseases and clinical significance of treatment with inclisiran

Abstract

Inclisiran is a novel lipid-lowering drug utilizing synthetic siRNA that inhibits the hepatic production of PCSK9. It is the first representative of an innovative concept of treating elevated levels of low-density lipoprotein cholesterol (LDL-C). The efficacy and safety of treatment with inclisiran is assessed in the ORION program of clinical trials. Inclisiran, administered once in six months, has been shown in phase 2 and 3 trials to reduce LDL-C by approximately 50% and to be effective in both patients with atherosclerotic cardiovascular disease and those with a high cardiovascular risk, including patients with heterozygous familial hypercholesterolemia. Additional phase 3 clinical trials aimed at providing evidence on long-term safety and efficacy of treatment with inclisiran and the ORION-4 trial focused on assessing the impact on cardiovascular morbidity and mortality are currently underway.