Related Experiment Video
Updated: Jun 5, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Efficacy and Safety of Inclisiran-An Assessment of the Consistency Between Randomized Controlled Trials and
Yaru Lin1, Haixiong Wang2, Han Yang1
1Academy of Medical Sciences, Shanxi Medical University, 030001 Taiyuan, Shanxi, China.
Background:
This study aimed to compare the consistency in low-density lipoprotein cholesterol (LDL-C) reduction and the safety profile of the novel lipid-lowering agent inclisiran between randomized controlled trials (RCTs) and real-world evidence (RWE).
Methods:
A systematic search of the PubMed, Embase, and Web of Science databases (2022-2025) identified three RCTs (n = 1833) and five RWE studies (n = 805). LDL-C reduction in the RCTs at 540 days was compared with that observed at 90 days in the RWE studies. Subgroup analyses were performed for patients with and without diabetes.
Results:
Four of the five RWE studies showed complete overlap of confidence intervals with the RCT results. Weighted regression analysis demonstrated a strong positive association between the reduction in LDL-C reported in the RCTs and RWE studies (R2 = 0.774; p = 0.004). The diabetic subgroup exhibited significantly greater LDL-C reduction than the overall RWE population (p = 0.003), with absolute differences ranging from 2.3% to 4.8% compared with corresponding RCTs. Safety profiles were comparable across study types, with differences in adverse event incidence of less than 5%. Injection-site reactions were the most frequently reported adverse events.
Conclusion:
Inclisiran demonstrated highly consistent LDL-C-lowering efficacy and a comparable safety profile across both RCTs and real-world settings.
The Prospero Registration:
CRD42024618982, URL: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024618982.
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