{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["13"],"submitter":["Cicero AFG"],"pubmed_abstract":["<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 (M"],"journal":["American heart journal plus : cardiology research and practice"],"pagination":["100127"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10978220"],"repository":["biostudies-literature"],"pubmed_title":["Efficacy and safety of inclisiran a newly approved FDA drug: a systematic review and pooled analysis of available clinical studies."],"pmcid":["PMC10978220"],"pubmed_authors":["Borghi C","Zambon A","Toth PP","Fogacci F","Cicero AFG"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy and safety of inclisiran a newly approved FDA drug: a systematic review and pooled analysis of available clinical studies.","description":"<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 (M","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jan","modification":"2026-06-01T09:51:35.168Z","creation":"2025-04-06T07:46:34.702Z"},"accession":"S-EPMC10978220","cross_references":{"pubmed":["38560059"],"doi":["10.1016/j.ahjo.2022.100127"]}}