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REVIEW article

Front. Public Health
Sec. Life-Course Epidemiology and Social Inequalities in Health
Volume 12 - 2024 | doi: 10.3389/fpubh.2024.1412874

The Diabetes Cardiovascular Outcomes Trials and Racial and Ethnic Minority Enrollment: Impact, Barriers, and Potential Solutions

Provisionally accepted
Matthew R. Sinclair Matthew R. Sinclair 1,2*Mariam Ardehali Mariam Ardehali 1*Clarissa J. Diamantidis Clarissa J. Diamantidis 3*Leonor Corsino Leonor Corsino 1*
  • 1 School of Medicine, Duke University, Durham, United States
  • 2 Duke Clinical Research Institute, School of Medicine, Duke University, Durham, North Carolina, United States
  • 3 School of Medicine, Wake Forest University, Winston-Salem, North Carolina, United States

The final, formatted version of the article will be published soon.

    Type 2 diabetes (T2D) affects millions of individuals worldwide and is a well-documented risk factor for cardiovascular (CV) disease and chronic kidney disease, both of which are leading causes of mortality. Racial and ethnic minority groups in the US, including but not limited to Hispanic/Latino, non-Hispanic Black, and Southeast Asian individuals, are disproportionately burdened by both T2D and its adverse outcomes. In recent years, there have been numerous cardiovascular outcomes trials (CVOTs) on novel antidiabetic therapies, including the dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), and sodiumglucose cotransporter-2 (SGLT2) inhibitors. CVOTs's initial aim was to demonstrate the cardiovascular safety of these drugs. Unexpected CV and kidney protective effects were found, specifically among the GLP-1 RAs and the SGLT2 inhibitors. These benefits informed the new paradigm of the management of patients with T2D. However, some experts argued that the lack of racial and ethnic minority group representation in these trials represented a challenge. While the downstream effects of this lack of representation must be further elucidated, it is clear and recognized that efforts need to be made to include a more representative sample in future CVOTs, specifically including individuals from those groups most burdened by T2D and its complications, if clinicians are to have an accurate picture of the benefits and potential pitfalls of utilizing these drugs in a real-world setting. In this comprehensive review, we briefly summarize the significant findings from the CVOTs, report the lack of representation of Hispanic/Latino, non-Hispanic Black, and Southeast Asian individuals in the CVOTs, investigate the barriers to recruiting racial and ethnic minority groups in clinical trials, and suggest potential solutions to overcome these obstacles at the patient-, provider-, and sponsor/system-level in future trials.

    Keywords: Cardiovascular outcome trials, Minority enrollment, Diabetes Mellitus, Kidney disease-therapy, cardiovascular disease

    Received: 05 Apr 2024; Accepted: 13 Sep 2024.

    Copyright: © 2024 Sinclair, Ardehali, Diamantidis and Corsino. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Matthew R. Sinclair, School of Medicine, Duke University, Durham, United States
    Mariam Ardehali, School of Medicine, Duke University, Durham, United States
    Clarissa J. Diamantidis, School of Medicine, Wake Forest University, Winston-Salem, 27157, North Carolina, United States
    Leonor Corsino, School of Medicine, Duke University, Durham, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.