Representativity of women and racial/ethnic minorities in randomized clinical trials on bempedoic acid: Positive efforts and lacking data

  • Federica Fogacci
    Affiliations
    Hypertension and Cardiovascular Risk Factors Research Group, Medical and Surgical Sciences Department, University of Bologna, 40138 Bologna, Italy

    IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
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  • Davide Gori
    Affiliations
    Department of Biomedical and Neuromotor Sciences, University of Bologna, 40138 Bologna, Italy
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  • Arrigo F.G. Cicero
    Correspondence
    Corresponding author: Prof. Dr. Arrigo F.G. Cicero, MD, PhD, Sant'Orsola-Malpighi University Hospital, Building 2 –IV Floor, Via Albertoni 15, 40138 Bologna, Italy.
    Affiliations
    Hypertension and Cardiovascular Risk Factors Research Group, Medical and Surgical Sciences Department, University of Bologna, 40138 Bologna, Italy

    IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
    Search for articles by this author
Published:November 13, 2021DOI:https://doi.org/10.1016/j.ejim.2021.11.006
      Even though today there is recognition of the need to proportionally include in clinical trials and prospectively evaluate women and racial minorities through all phases of drug development, in previous decades the consideration and inclusion of men of Caucasian race overshadowed women and racial/ethnic minorities in clinical research design and conduct [
      • Legato M.J.
      • Johnson P.A.
      • Manson J.E.
      Consideration of Sex Differences in Medicine to Improve Health Care and Patient Outcomes.
      ]. To counter this disparity, the US Food and Drug Administration (FDA) has implemented since 1993 guidelines encouraging greater participation of women and the need for diverse demographic enrolment [
      U.S
      ]. Although these policies may have gradually increased participation, women and racial minorities continued for a long time to be underrepresented in randomized clinical trials testing lipid-lowering therapies (i.e. statins, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, ezetimibe, bile acid sequestrants, fibrates, niacin, and omega-3 polyunsaturated fatty acids) [
      • Khan S.U.
      • Khan M.Z.
      • Raghu Subramanian C.
      • Riaz H.
      • Khan M.U.
      • Lone A.N.
      • Khan M.S.
      • Benson E.M.
      • Alkhouli M.
      • Blaha M.J.
      • Blumenthal R.S.
      • Gulati M.
      • Michos E.D
      Participation of women and older participants in randomized clinical trials of lipid-lowering therapies: a systematic review.
      ]. In this context, we sought to investigate presence of disparities in trials testing the new emergent lipid-lowering drug bempedoic acid (BA) [
      • Westerink J.
      Bempedoic acid: everything with a place and purpose.
      ].

      Keywords

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