Abstract

Introduction: The prevalence of type 2 diabetes mellitus (T2DM) is higher in black individuals than non-Hispanic white individuals. Recent cardiovascular (CV) outcome trials have demonstrated CV benefit of glucagon-like peptide 1 (GLP-1) receptor agonists in patients with T2DM and high CV risk. Whether the benefit seen in the overall trial population extends to the subgroup of black individuals is not known given the limited sample size. Methods: We performed a meta-analysis of randomized CV outcome trials published after the issuance of Food and Drug Administration Guidance on antihyperglycemic medications in 2008. Results: Five trials assessing the CV benefit of GLP-1 receptor agonists in T2DM were identified (ELIXA, LEADER, SUSTAIN-6, EXSCEL, and HARMONY). ELIXA was excluded given the different primary outcome studied and the lack of complete outcome data by race. The four trials included in this meta-analysis enrolled 36,852 individuals, including 2,101 black participants (6%). The prevalence of black patients in the individual clinical trials ranged from 2% in the HARMONY trial to 8% in the LEADER trial. The composite primary outcome of CV death, non-fatal MI, or non-fatal stroke was recorded in 114 out of 1,031 black patients (11%) treated with a GLP-1 analogue compared to 136/1070 (13%) treated with placebo (Hazard Ratio 0.96, 95% Confidence Interval 0.57-1.62). The test for heterogeneity was significant (p=0.04). Conclusions: Despite the high prevalence of T2DM in black individuals, they remain underrepresented in the clinical trials assessing the effect of GLP-1 receptor agonists on CV outcomes in T2DM. The results of this meta-analysis suggest heterogeneity in the studies that have been performed to date. Future studies are needed to confirm the benefit of GLP-1 receptor agonists in black individuals with T2DM and high CV risk. Figure: Hazard ratios of cardiovascular death, non-fatal MI, or non-fatal stroke in black patients with diabetes type 2 treated with a glucagon-like peptide-1 analogue versus placebo

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