Efficacy and safety of inclisiran a newly approved FDA drug: a systematic review and pooled analysis of available clinical studies.

ABSTRACT:

Study objective

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).

Design

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.

Results

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

SUBMITTER: Cicero AFG 

PROVIDER: S-EPMC10978220 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature