Introduction:
Cholesterol management is the cornerstone of atherosclerotic cardiovascular disease prevention. Diverse racial/ethnic participation in high-impact cholesterol trials is essential for the generalizability of trials and guidelines across the United States (US).
Methods:
We analyzed randomized clinical trials (RCTs) cited in the 2018 American Multi-society Guideline on the Management of Blood Cholesterol for reporting and representation of racial/ethnic minorities. We extracted participant level racial/ethnic data, including non-Hispanic White (NHW), Black, Hispanic, or Asian groups. For each race/ethnicity, we pooled trial data to assess overall representation compared to the general US population based on 2010 US Census and 2019 US Census American Community Survey estimates.
Results:
Among 71 cited RCTs from 1984 - 2017, 59.1% reported racial/ethnic data. NHW participation was reported in 58%, Black in 34%, Hispanic in 27%, and Asian in 17% (Figure). Four trials disaggregated Hispanic patients and none disaggregated Asians. Black trial representation was significantly lower than the US population per 2010 and 2019 Census data (trial: 5.5%, 2010: 12.6%, 2019: 13.4%,
P
<0.001). Hispanic trial representation was significantly lower compared to the US population (trial: 10.6%, 2010: 16.3%, 2019: 18.3%,
P
<0.001). NHW trial participation was lower compared to the US population (trial 69.2%; 2010: 72.4%; 2019: 76.5%,
P
<0.001), but with smaller relative differences compared to Black and Hispanic representation. Asian participation was higher than US census representation.
Conclusion:
Among guideline-driving cholesterol RCTs, Black and Hispanic participants are significantly underrepresented compared to the general U.S. population. Few studies disaggregate major racial/ethnic subgroups. These findings represent a source of systemic bias that may limit the generalizability of trials and guidelines and potentiate health inequities.