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In Silico Clinical Trials for Cardiovascular Disease
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Hispanic representation in diabetes cardiovascular outcomes trials
A Taylor Kelley1,2,3,4, Kara Mizokami-Stout1,2,3,4,5, Matthew J O'Brien6
1Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.
BMJ Open Diabetes Research & Care
|June 28, 2019
Summary
Representation of Hispanic/Latino adults in diabetes trials is similar to the US population. However, trial participants differ in age, sex, and obesity, potentially limiting generalizability of findings for novel antidiabetic drugs.
Area of Science:
- Clinical research
- Cardiovascular outcomes
- Diabetes mellitus
Background:
- Diabetes cardiovascular outcomes trials (CVOTs) are crucial for evaluating novel antidiabetic drugs.
- Ensuring diverse representation in clinical trials is essential for generalizable results.
Purpose of the Study:
- To examine Hispanic/Latino representation in diabetes CVOTs for novel antidiabetic drugs.
- To compare demographic and anthropometric characteristics of Hispanic/Latino participants in CVOTs with the general US Hispanic/Latino population with diabetes.
Main Methods:
- A systematic review of diabetes CVOTs published from January 2008 to October 2018 was conducted.
- Hispanic/Latino representation, age, gender, and body mass index (BMI) in trials were compared to data from the National Health Examination and Nutrition Survey (NHANES) for US adults with diabetes.
Main Results:
- Hispanic/Latino individuals constituted 18.5% of trial subjects, mirroring their proportion in the US adult diabetic population.
- Trial participants were significantly younger, more frequently female, and had higher BMI compared to US Hispanics/Latinos with diabetes.
- Participants from at least 10 Latin American countries were included across the 10 analyzed trials.
Conclusions:
- While Hispanic/Latino representation in diabetes CVOTs is comparable to the US population, significant demographic and anthropometric differences exist between trial subjects and the broader US Hispanic/Latino population with diabetes.
- These disparities may impact the generalizability and applicability of findings from novel antidiabetic drug trials to diverse Hispanic/Latino communities.
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