The Efficacy and Safety of Inclisiran for Low-Density Lipoprotein (LDL) in Patients With Atherosclerotic Cardiovascular Disease (ASCVD): A Systematic Review of Randomized Controlled Trials

This systematic review synthesizes current evidence to evaluate the safety and efficacy of inclisiran for lowering low-density lipoprotein cholesterol (LDL-C). A thorough search was conducted across four main databases - PubMed, Web of Science, SCOPUS, and Science Direct - for relevant studies published in the literature within the last five years (2020-2024). We included seven studies with a total of 6831 participants, of which 4661 (68.2%) were males. The follow-up duration ranged from 60 to 1350 days. The intervention we focused on was a subcutaneous injection of inclisiran (284 mg) in the seven trials. Of the total population, 2411 (35%) had diabetes mellitus (DM) and 5335 (78.1%) had hypertension (HTN). The seven trials documented a significant reduction in the mean LDL-C level following the inclisiran application. Early inclisiran administration recorded better results. Inclisiran was found to be efficient, safe, and tolerable among atherosclerotic cardiovascular disease (ASCVD) patients. An inclisiran regimen of 284 mg proved to be efficacious and safe for reducing ASCVD. Most of the affected participants were males and hypertensive. Our findings highlight the need for additional clinical trials to examine inclisiran's safety and effectiveness with regard to cardiovascular outcomes. Extended surveillance studies may yield deeper insights into the efficacy, durability, and tolerability of inclisiran.