Importance of Diversity in High-impact Cholesterol Treatment Trials

by Amanda Chase, PhD
August 6, 2021

Heart disease is the leading cause of death in the US, with about 655,000 Americans dying each year from heart disease. Heart disease refers to several types of heart conditions, including genetic diseases, decreased pumping capacity and heart failure, stroke, and non-fatal heart attack. It is well known that lifestyle changes, such as healthy diet and exercise, can serve as prevention for heart disease, and other factors can contribute to increased risk (e.g., age, smoking, family history). A healthy lifestyle reduces atherosclerotic cardiovascular disease (ASCVD) risk. An individual’s risk for CVD is the basis of prevention of cardiovascular disease, and ranges from lifestyle adjustment to therapy treatment (e.g, statins). Randomized cholesterol treatment clinical trials are used to inform treatment guidelines which can guide clinicians into shared treatment decisions based on ASCVD risk.  

In a recent Circulation manuscript, Cardiovascular Institute affiliated researchers, led by first author Ashish Sarraju, MD, and senior author Fatima Rodriguez, MD, MPH, presented the need for improved diverse racial and ethnic group representation in high-impact cholesterol treatment trials. There are known important racial/ethnic differences in both cardiovascular disease risk and in cholesterol management that should be considered when devising a treatment plan. The research team evaluated the reporting and representation of diverse racial/ethnic groups in clinical trials used to create the current Guideline on Management of Blood Cholesterol.

Figure. Racial/ethnic representation among trial participants compared with the US population per the Census estimates. NHW indicates non-Hispanic White people.

They found that Black, Hispanic, and Asian participation were significantly underrepresented compared to US Census data. This has critical implications for the real-world applicability and generalizability of both the cholesterol clinical trials and the guidelines. Moving forward, sustained efforts to recruit and retain diverse participants in clinical trials will lead to more generalizable guidelines in the future.

Other Cardiovascular Institute affiliated authors include Joshua Knowles, MD, PhD, and David Maron, MD, along with Stanford affiliated author Areli Valencia.

Ashish Sarraju, MD

Fatima Rodriguez, MD, MPH