GLP-1 receptor agonists and cardiovascular outcomes in Asian, Black or African American, and White populations: An updated meta-analysis including the SOUL trial.
Hasebe M, Su CY, Kamido H, Yabe D, Yoshiji S
GLP-1 receptor agonists reduced cardiovascular risk by 27% in Asian populations versus 14% in White populations, with similar but non-significant effects in Black or African American populations. Meta-analysis of 9 trials including 74,703 participants with type 2 diabetes or overweight/obesity. This provides the first robust evidence of differential GLP-1RA cardiovascular benefits across racial groups, with Asian populations showing significantly greater relative risk reduction. The finding emerges from inclusion of the recent SOUL trial data.
Strategic Signal
FDA will face pressure to include race-specific efficacy data in GLP-1RA labels, following precedents set by BiDil for heart failure and recent FDA guidance on diverse clinical trial enrollment. Novo Nordisk and Eli Lilly can leverage the stronger Asian efficacy data for market access in Japan and other Asian markets where HTA bodies increasingly demand population-specific evidence. The non-significant result in Black populations, despite similar point estimates, creates a medical affairs challenge requiring careful KOL education to avoid misinterpretation of statistical versus clinical significance.