Representativeness of women and racial/ethnic minorities in randomized clinical trials on bempedoic acid

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Background Women and racial minorities have 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). Purpose We sought to investigate presence of disparities in trials testing the new emergent lipid-lowering drug bempedoic acid (BA). Methods Several databases were searched with the use of a purposedly developed search strategy. To minimize the chances of missing data, the identified clinical trials were subsequently searched on http://www.clinicaltrials.gov. Original studies were included in the analysis if they met the following inclusion criteria: (i) being a clinical trial with either multicentre or single-centre design and (ii) having an appropriate controlled design for BA. Results Considering together, the overall participation rate and the mean participation rate across the clinical studies, men, whites and non-Hispanic/Latinos were sufficiently represented compared with their proportion in the disease population. Non-whites and Asians were underrepresented. Women, blacks and Hispanic/Latinos were from adequately to over-represented across clinical trials, though in the pooled population their portion was lower than their share of the disease population. Conclusions Further efforts are needed to enhance the representativeness of clinical trials according to race and sex and ensure complete information about efficacy and safety of treatment with BA.