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

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 . 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. 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). In this context, we sought to investigate presence of disparities in trials testing the new emergent lipid-lowering drug bempedoic acid (BA)