South Asian Representation in Cardiovascular Disease Randomized Controlled Trials: A Systematic Review.

Area of Science:

• Cardiology
• Clinical Trials
• Health Disparities

Background:

• South Asian individuals represent 25% of the global population and are at increased risk for cardiovascular disease (CVD).
• Representation of South Asian populations in cardiovascular disease (CVD) randomized controlled trials (RCTs) is not well understood.
• Understanding this representation is critical for addressing health disparities in CVD.

Purpose of the Study:

• To systematically review and quantify South Asian representation in major cardiovascular disease (CVD) randomized controlled trials (RCTs).
• To extract post-randomization primary outcome estimates for South Asian participants in these trials.

Main Methods:

• A systematic review of major cardiovascular disease (CVD) randomized controlled trials (RCTs) published between 2018 and 2022.
• Manual screening of each study to identify and quantify South Asian participants.
• Prospective registration of the review protocol in PROSPERO (CRD42023396522).

Main Results:

• 310 RCTs were included, with 1,036,737 total participants, of whom 32,764 (3.2%) were of South Asian ancestry.
• Excluding a large trial in India, South Asian representation dropped to 1.1% of total participants.
• Representation varied by condition, with highest inclusion in coronary artery disease trials (9.0%) and none in heart failure, cardiac arrest, or valvular heart disease trials.
• Post-randomization data were available for 7.3% of all participants with such data.

Conclusions:

• South Asian individuals are significantly underrepresented in major cardiovascular disease (CVD) randomized controlled trials (RCTs).
• There is an urgent need to enhance enrollment initiatives for South Asian populations in CVD clinical trials.
• Further research is required to determine if this underrepresentation contributes to the elevated CVD risk observed in this demographic.