{"id":"doi:10.31083/rcm48272","kind":"review","title":"Efficacy and Safety of Inclisiran-An Assessment of the Consistency Between Randomized Controlled Trials and Real-World Evidence: A Systematic Review","authors":["Lin Y","Wang H","Yang H","Li Z"],"author_count":4,"year":2026,"published":"2026-05-26","venue":"Reviews in cardiovascular medicine","cited_by":0,"doi":"10.31083/rcm48272","arxiv_id":null,"nct_id":null,"source_url":"https://doi.org/10.31083/rcm48272","archive_url":"https://space-kitty.com/papers/doi:10.31083/rcm48272","updated":null,"pmid":"42238630","pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"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 (R 2 = 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.","abstract_license":"CC-BY (article license as recorded by Europe PMC; abstract reproduced unmodified apart from markup removal)","license":"CC-BY","is_open_access":false,"retracted":false,"peer_reviewed":null,"categories":[],"details":null,"provenance":"europepmc","attribution":"Abstract of \"Efficacy and Safety of Inclisiran-An Assessment of the Consistency Between Randomized Controlled Trials and Real-World Evidence: A Systematic Review\" by Lin Y, Wang H, Yang H et al., https://doi.org/10.31083/rcm48272, used under its Creative Commons Attribution license (CC-BY); markup removed, otherwise unmodified.","topics":[{"slug":"cardiovascular-innovation","name":"Cardiovascular Therapeutics","domain_slug":"medicine"}],"cited_in_dossiers":[]}