Under-reporting and under-representation of non-Hispanic Black subjects in lipid-lowering atherosclerotic cardiovascular disease outcomes trials: A systematic review

• Published in: Journal of clinical lipidology 2022-09, Vol.16 (5), p.608-616
• Main Authors: Grant, Jelani K., Dangl, Michael, Koester, Margaret, Tegegn, Mickias, Knijnik, Leonardo, Singh, Harjit, Orringer, Carl E.
• Format: Article
• Language: English
• Subjects: Lipid-lowering; Non-hispanic black; Randomized controlled trials; Under-reporting; Under-representation
• ISSN: 1933-2874; 1876-4789
• DOI: 10.1016/j.jacl.2022.08.005

•Black subjects are under-reported in lipid-lowering ASCVD outcomes trials.•Black subjects are under-represented in lipid-lowering ASCVD outcomes trials.•Inclusion of Black persons will help to address disparities in preventive care. Non-Hispanic (NH) Black participants have been under-represented in studies of cardiovascular disease. We sought to determine the trends of reporting and representation of NH Black subjects in randomized controlled trials (RCTs) of lipid-lowering therapies demonstrating atherosclerotic cardiovascular disease (ASCVD) risk reduction benefit. The electronic databases of MEDLINE, EMBASE and ClinicalTrials.gov were searched from 1990-2020. Studies of lipid-lowering therapies (i.e., statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitors [PCSK9], and icosapent ethyl) with proven ASCVD benefit, sample sizes of at least 1000 subjects and follow-up of at least 1 year were included (40 RCTs, N=306 747 total participants). We examined articles and supplementary material for participant-level race data. Using United States disease prevalence data, the participation-to-prevalence ratio (PPR) metric was used to estimate the representation of NH Black subjects compared with their reported disease burden (i.e., < 0.8 indicated under-representation; > 1.2, over-representation; and 0.8 to