Abstract
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 [ [1] Legato M.J. Johnson P.A. Manson J.E. Consideration of Sex Differences in Medicine to Improve Health Care and Patient Outcomes. JAMA. 2016; 316: 1865-1866https://doi.org/10.1001/jama.2016.13995 Crossref PubMed Scopus (88) Google Scholar ]. 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 [ [2] U.SGuideline for the study and evaluation of gender differences in the clinical evaluation of drugs. 58. Food and Drug Administration, 1993: 39406-39416 Google Scholar ]. 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) [ [3] 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. JAMA Netw Open. 2020; 3e205202 Crossref PubMed Scopus (34) Google Scholar ]. In this context, we sought to investigate presence of disparities in trials testing the new emergent lipid-lowering drug bempedoic acid (BA) [ [4] Westerink J. Bempedoic acid: everything with a place and purpose. Eur J Prev Cardiol. 2020; 2047487320929779https://doi.org/10.1177/2047487320929779 Crossref Scopus (2) Google Scholar ].
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