AIM To evaluate the generalizability of cardiovascular outcome trials (CVOTs) on glucagon-like peptide-1 receptor agonists (GLP-1RAs), we assessed what proportion of real-world patients with type 2 diabetes (T2D) constitute true CVOT-like populations. MATERIALS AND METHODS We applied inclusion/exclusion (I/E) criteria of each GLP-1RA CVOT to a cross-sectional database of 281 380 T2D patients from Italian diabetes outpatient clinics. We calculated the proportion of patients eligible for each CVOT and compared their clinical characteristics with those of trial patients. In addition, we used a Bayesian network-based method to sample the greatest subsets of real-world patients yielding true CVOT-like populations. RESULTS Between 98 725 and 124 164 T2D patients could be evaluated for CVOT eligibility. After excluding patients who were already on GLP-1RAs and applying I/E criteria, 35.8% of patients would be eligible for REWIND, 34.1% for PIONEER-6, 13.4% for EXSCEL, 10.1% for SUSTAIN-6, 9.5% for HARMONY and 9.4% for LEADER. Overall, 45.4% of patients could be eligible for at least one of the CVOTs. These patients, however, were extremely different to trial patients in most of the clinical characteristics, including demographics, concomitant medications and complications. The greatest CVOT-like subsets of real-world patients were 0.5% for SUSTAIN-6, 1.0% for EXSCEL, 1.2% for LEADER, 1.8% for PIONEER-6 and 7.9% for REWIND. CONCLUSIONS A very small proportion of real-world patients constitute true CVOT-like populations. These findings question whether any meaningful information can be drawn from applying trial enrolment criteria to real-world T2D patients.

中文翻译：

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糖尿病心血管结局试验的入选标准并未告知临床实践的普遍性：胰高血糖素样肽1受体激动剂。

目的为了评估针对胰高血糖素样肽-1受体激动剂（GLP-1RA）的心血管结局试验（CVOT）的可推广性，我们评估了真实世界中2型糖尿病（T2D）患者构成真正CVOT样人群的比例。材料和方法我们将每个GLP-1RA CVOT的纳入/排除（I / E）标准应用于来自意大利糖尿病门诊的281380名T2D患者的横断面数据库。我们计算了每种CVOT合格患者的比例，并将其临床特征与试验患者进行了比较。此外，我们使用了基于贝叶斯网络的方法，对产生真实CVOT类人群的真实世界患者的最大子集进行采样。结果可以评估98 725至124 164位T2D患者的CVOT资格。在排除已经使用GLP-1RA并应用I / E标准的患者之后，有35.8％的患者符合REWIND的资格，PIONEER-6占34.1％，EXSCEL占13.4％，SUSTAIN-6占10.1％，HARMONY占9.5％。和9.4％的LEADER。总体而言，有45.4％的患者符合至少一种CVOT的资格。但是，这些患者在大多数临床特征（包括人口统计学，伴随用药和并发症）方面与试验患者截然不同。现实世界中最大的类CVOT子集患者为SUSTAIN-6为0.5％，EXECEL为1.0％，LEADER为1.2％，PIONEER-6为1.8％，REWIND为7.9％。结论现实世界中只有极少数患者构成真正的CVOT类人群。