Clinical Efficacy and Cholesterol-Lowering Effects of Inclisiran

Abstract

Inclisiran, a drug developed by Novartis, is a recent medication designed to alleviate cardiovascular disease symptoms through improving low-density lipoprotein cholesterol levels. Mechanistically, inclisiran is a chemically synthesized small interfering RNA (siRNA) molecule targeting serine protease proprotein convertase subtilisin-kexin type 9 (PCSK9), resulting in degradation of the LDL receptor. Positive, large-scale clinical trials on the use of inclisiran demonstrate the drug’s efficacy in reducing LDL cholesterol levels in patients afflicted with cardiovascular disease. Moreover, Novartis and the National Health Services (NHS) of the UK have very recently come to an agreement (September 1st, 2021) on the drug’s utility, as the NHS has enabled inclisiran’s use in more than 300,000 patients with a history of cardiovascular disease. However, despite the promising clinical trials on inclisiran as well as its use in the UK, the U.S. Food and Drug Administration (FDA) has yet to approve the drug as a treatment strategy for cardiovascular disease. This review will analyze and discuss the clinical efficacy of inclisiran based on the recent clinical evidence for its pharmacological use in the treatment of cardiovascular diseases. Key words: Inclisiran, efficacy, cholesterol-lowering