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

• 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-represen...

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Publicado en:Journal of Clinical Lipidology Vol. 16; no. 5; pp. 608 - 617
Autores principales: Grant, Jelani K., Dangl, Michael, Koester, Margaret, Tegegn, Mickias, Knijnik, Leonardo, Singh, Harjit, Orringer, Carl E.
Formato: research systematic review Journal Article
Publicado: Elsevier B.V. Sep2022
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Sep2022
      vid: 16
      iid: 5
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      pub: Elsevier B.V.
      place: New York, New York
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        10.1016/j.jacl.2022.08.005
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        atl: Under-reporting and under-representation of non-Hispanic Black subjects in lipid-lowering atherosclerotic cardiovascular disease outcomes trials: A systematic review.
      aug:
        au:
          Grant, Jelani K.
          Dangl, Michael
          Koester, Margaret
          Tegegn, Mickias
          Knijnik, Leonardo
          Singh, Harjit
          Orringer, Carl E.
        affil: Department of Medicine, Cardiovascular Division, Johns Hopkins University School of Medicine, Baltimore, MD, USA, 21287
      sug:
        subj:
          Research Subject Recruitment Trends
          Black Persons Statistics and Numerical Data
          Antilipemic Agents Therapeutic Use
          Hyperlipidemia Drug Therapy
          Atherosclerosis Prevention and Control
          Cardiovascular Diseases Prevention and Control
          Randomized Controlled Trials
          Human
          Systematic Review
          Medline
          Embase
          Hypercholesterolemia Drug Therapy
          Triglycerides Blood
          Statins Therapeutic Use
          Ezetimibe Therapeutic Use
          Peptide Hydrolases Antagonists and Inhibitors
          Eicosapentaenoic Acid Therapeutic Use
          PCSK9 Inhibitors Therapeutic Use
          African Americans Statistics and Numerical Data
          Descriptive Statistics
          Confidence Intervals
      ab: • 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 <1.2, adequate representation). The median (interquartile range) number of participants per trial was 4871 (2434-10077). NH Black enrollees comprised 7.3% (95% CI, 0.9%-15.4%) of the total number of subjects reported. During the time intervals 1990-1995, 1996-2000, 2001-2005, 2006-2010, 2011-2015 and 2016-2020, NH Black participation was 0%, 1.1%, 4.4%, 4.8%, 0.2% and 0.7% respectively (P for trend <0.001). For statin trials, the participation of NH Black subjects was reported in 0 studies between 1990-1995 and in 9 of 28 trials from 1996-2020. For ezetimibe and icosapent ethyl, NH Black participants were reported in 0 of 3 and 0 of 1 studies, respectively. For trials of PCSK9 inhibitors, NH Black subjects were reported in 2 of 5 (40%). NH Black participants were under-represented compared with their disease burden in studies evaluating subjects with diabetes, hypercholesterolemia, stable coronary artery disease, and acute coronary syndrome (PPR < 0.8 for all). NH Black participants are markedly under-represented, and results are under-reported. The inclusion of population and disease specific representation of NH Black persons and their related social determinants of health will help to address the disparity in preventive care for this historically undertreated population. [Display omitted]
      pubtype: Academic Journal
      doctype:
        research
        systematic review
        Journal Article
      ougenre: Article
    language: English
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