BACKGROUND: To our knowledge, inclisiran was the first agent composed of small 
interfering RNAs (siRNAs) to be preliminarily used to reduce proatherogenic 
lipoprotein cholesterol levels. Inclisiran was evaluated in large clinical 
trials but did not receive government approval. The ability of inclisiran to 
reduce low-density lipoprotein cholesterol (LDL-C) greatly improved its chances 
of becoming a novel therapeutic option for patients with hyperlipidemia.
OBJECTIVE: Our goal was to summarize the preliminary effectiveness and safety 
data for inclisiran.
METHODS: We conducted a comprehensive search of PubMed, Scopus, Web of Science, 
the OVID EMB Reviews database, and Clinical Trials with the keyword "inclisiran" 
to find all related randomized controlled trials (RCTs). Five recently published 
RCTs involving 583 adults aged 18-65 years with hyperlipidemia were included in 
the analysis.
RESULTS: Subgroup analysis suggested that inclisiran 100 mg (standard mean 
difference [SMD] - 2.09; 95% confidence interval [CI] - 2.51 to - 1.66; 
p < 0.05), 300 mg (SMD - 2.74; 95% CI - 3.61 to - 1.87; p < 0.05), and 500 mg 
(SMD - 2.21; 95% CI - 2.62 to - 1.80; p < 0.05) significantly (p < 0.05) reduced 
LDL-C and total cholesterol even though pooled analysis showed no LDL-C-lowering 
effect (SMD 0.15; 95% CI - 0.34 to 0.04; p = 0.116). Compared with patients 
receiving placebo, pooled and subgroup analysis of patients receiving inclisiran 
showed no favorable changes in triglycerides or high-density lipoprotein 
cholesterol (p > 0.05). The most commonly reported adverse events were 
musculoskeletal pain, nasopharyngitis, headache, and elevated C-reactive protein 
(CRP), none of which were significant (p > 0.05).
CONCLUSIONS: To date, inclisiran has been effective in treating hyperlipidemia. 
Major adverse events were not identified, although other possible adverse events 
may be discovered with more RCTs and extensive long-term follow-up.