1 BACKGROUND

Racial and ethnic diversity in clinical trials serves as a metric of societal equality and access to healthcare. Unfortunately, as in most large-scale studies of cardiovascular (CV) benefits/risks, the Black populations have been vastly under-represented, creating challenges in interpreting underpowered subgroup analyses from individual trials.¹ Limited generalizability of the trial findings may perpetuate disparities in clinical outcomes by precluding precision health approaches.

To date, evidence from CV and renal outcome trials and their meta-analyses have shown that treatment with sodium-glucose co-transporter-2 (SGLT2) inhibitors or glucagon-like peptide-1 receptor agonists (GLP-1RAs) provides cardiorenal benefits among individuals with or without type 2 diabetes (T2D).² However, it remains unclear whether the cardiorenal benefits of the newer agents are generalizable to racial and ethnic minority groups. Thus, in this study, we conducted a meta-analysis of CV and renal outcome trials to determine the effects of dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1RAs, and SGLT2 inhibitors on cardiorenal outcomes in Black and White participants with or without T2D. We further applied trial sequential analysis to determine whether the sample size available for Black participants was deemed of sufficient power to reach a reliable conclusion.

Racial/ethnic diversity in research, especially in clinical trials that establish standards of care, is necessary to minimize disparities in outcomes and to uphold societal equity in healthcare.¹ This study intended to address an omnipresent failure in the chain of health equity: under-enrolment of socially disadvantaged populations in key clinical trials of potentially life-saving treatments and its negative consequences on the external validity, equality, and scientific rigour of research.

中文翻译：

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新型降糖药对心肾的益处是否可推广到黑人种族？一项荟萃试验序贯分析，以解决心血管和肾脏结果试验招募中的差异

1 背景

临床试验中的种族和民族多样性是衡量社会平等和获得医疗保健的指标。不幸的是，与大多数关于心血管 (CV) 益处/风险的大规模研究一样，黑人人群的代表性严重不足，这给从个别试验中解释动力不足的亚组分析带来了挑战。¹试验结果的有限普遍性可能会通过排除精确的健康方法而使临床结果的差异长期存在。

迄今为止，来自心血管和肾脏结果试验及其荟萃分析的证据表明，使用钠-葡萄糖协同转运蛋白 2 (SGLT2) 抑制剂或胰高血糖素样肽 1 受体激动剂 (GLP-1RA) 治疗在患有或未患有 2 型糖尿病 (T2D) 的人。²然而，尚不清楚新型药物的心肾益处是否可推广到种族和少数族裔群体。因此，在本研究中，我们对心血管和肾脏结果试验进行了荟萃分析，以确定二肽基肽酶 4 (DPP-4) 抑制剂、GLP-1RA 和 SGLT2 抑制剂对患有以下疾病的黑人和白人参与者的心肾结果的影响或没有 T2D。我们进一步应用试验顺序分析来确定黑人参与者可用的样本量是否被认为有足够的能力得出可靠的结论。

研究中的种族/民族多样性，特别是在建立护理标准的临床试验中，对于最大限度地减少结果差异和维护医疗保健的社会公平是必要的。¹本研究旨在解决健康公平链中普遍存在的失败问题：社会弱势群体在可能挽救生命的治疗的关键临床试验中参与不足，及其对研究的外部有效性、平等和科学严谨性的负面影响。