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Racial, ethnic and sex disparities among participants in cardiovascular outcomes trials in type 2 diabetes: A systematic review and descriptive analysis.

The objective of this study was to evaluate the representativeness of cardiovascular outcomes trials in type 2 diabetes with respect to sex, race, and ethnicity. We searched Pubmed, Embase and ClinicalTrials.gov up to 16 May 2022 for cardiovascular outcomes trials examining the effect of glucose-lowering medications on major adverse cardiovascular events in adults with type 2 diabetes. Continuous variables were summarized as median and interquartile range (IQR) values, and categorical variables as numbers and percentages. We also assessed the representation of women and racial/ethnic groups in included cardiovascular trials relative to their representation within the United States population of patients with type 2 diabetes. A total of 25 trials (n=188186 patients) were included in the analysis. Across all eligible trials, fewer women than men were recruited, representing 35.1% of all participants. Proportion of enrolled women remained unchanged over time. White patients comprised 77.2% (n=145348) of the overall population, whereas 12.1% (n=22776) and 4.6% (n=8696) were Asian and black, respectively. The proportion for each race enrolled did not change over time. Compared to the overall representation of racial groups within the United States population of patients with type 2 diabetes, black patients were underrepresented, while white patients were overrepresented. Future trials should aim for participant diversity to optimize care of all patients with type 2 diabetes and promote equity in healthcare provision. This article is protected by copyright. All rights reserved.