biostudies-literatureUnknown13Cicero AFG<h4>Study objective</h4>This systematic review and meta-analysis aimed to assess the efficacy and safety profile of treatment with inclisiran, a drug that has been recently approved by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).<h4>Design</h4>A systematic literature search was conducted in order to identify randomized controlled trials (RCTs) assessing the effect on lipoproteins and the safety profile of inclisiran.<h4>Results</h4>Data were pooled from 5 RCTs, which included 4226 subjects. Meta-analyses of data suggested that the multiple-dose regimens of inclisiran yielded a significant reduction in serum levels of proprotein convertase subtilisin/kexin type 9 (MD = -78.23%, 95%CI: -86.74, -69.71) and low-density lipoprotein cholesterol (MAmerican heart journal plus : cardiology research and practice100127https://www.ebi.ac.uk/biostudies/studies/S-EPMC10978220biostudies-literatureEfficacy and safety of inclisiran a newly approved FDA drug: a systematic review and pooled analysis of available clinical studies.PMC10978220Borghi CZambon AToth PPFogacci FCicero AFGfalseEfficacy and safety of inclisiran a newly approved FDA drug: a systematic review and pooled analysis of available clinical studies.<h4>Study objective</h4>This systematic review and meta-analysis aimed to assess the efficacy and safety profile of treatment with inclisiran, a drug that has been recently approved by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).<h4>Design</h4>A systematic literature search was conducted in order to identify randomized controlled trials (RCTs) assessing the effect on lipoproteins and the safety profile of inclisiran.<h4>Results</h4>Data were pooled from 5 RCTs, which included 4226 subjects. Meta-analyses of data suggested that the multiple-dose regimens of inclisiran yielded a significant reduction in serum levels of proprotein convertase subtilisin/kexin type 9 (MD = -78.23%, 95%CI: -86.74, -69.71) and low-density lipoprotein cholesterol (M2022-01-01T00:00:00Z2022 Jan2026-06-01T09:51:35.168Z2025-04-06T07:46:34.702ZS-EPMC109782203856005910.1016/j.ahjo.2022.100127