Enrolment criteria for diabetes cardiovascular outcome trials do not inform on generalizability to clinical practice: The case of glucagon-like peptide-1 receptor agonists.
糖尿病心血管结局试验的注册标准不告知临床实践的普遍性: 胰高血糖素样肽-1 受体激动剂的情况。
cardiovascular disease glucagon-like peptide-1 analogue pharmaco-epidemiology population study type 2 diabetes
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摘要

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.

译文

目的: 评估胰高血糖素样肽-1 受体激动剂 (GLP-1RAs) 心血管结局试验 (cvets) 的普遍性, 我们评估了真实世界中 2 型糖尿病 (T2D) 患者构成真正的 CVOT 样人群的比例。
材料和方法: 我们将每个 GLP-1RA 的纳入/排除 (I/E) 标准应用到来自意大利糖尿病门诊的 281 380 例 T2D 患者的横断面数据库中。我们计算了符合每个 CVOT 的患者比例,并将他们的临床特征与试验患者的临床特征进行了比较。此外,我们使用了一种基于贝叶斯网络的方法来对产生真正的 CVOT 样人群的真实患者的最大子集进行抽样。
结果: 在 98-725 和 124-164 T2D 患者之间可以评估 CVOT 资格。排除已经在 GLP-1RAs 并应用 I/E 标准的患者后,35.8% 的患者将有资格进行倒带,34.1% 的患者为 PIONEER-6,13.4% 的患者为 EXSCEL,10.1% 的患者为 suste-6, 9.5% 代表和谐,9.4% 代表领导者。总的来说,45.4% 的患者可以有资格获得至少一个 cvets。然而,这些患者在大多数临床特征上与试验患者极其不同,包括人口统计学、伴随药物和并发症。真实世界患者中最大的类似 CVOT 的子集是 0.5% 的 suste-6,1.0% 的 EXSCEL,1.2% 的 LEADER,1.8% 的 PIONEER-6 和 7.9% 的 REWIND。
结论: 很少一部分真实世界的患者构成真正的 CVOT 样人群。这些发现质疑是否可以从将试验注册标准应用于现实世界的 T2D 患者中获得任何有意义的信息。

Glucagon

内分泌 血糖 临床研究术语
概述  :  

胰高血糖素是一种肽类激素,通过胰腺的α细胞产生。它可以提高血液中葡萄糖和脂肪酸的浓度,被认为是人体的主要分解代谢激素。它还用作治疗多种健康状况的药物。它的作用与胰岛素相反,后者可降低细胞外葡萄糖。功能胰高血糖素通过促进糖原异生和糖原分解升高血液中的葡萄糖浓度,胰高血糖素还可以减少脂肪组织和肝脏中的脂肪酸合成,并促进这些组织中的脂肪分解,从而使它们将脂肪酸释放到循环系统中,在需要时可以分解代谢脂肪酸以在组织(例如骨骼肌)中产生能量。胰高血糖素的产生似乎依赖于中枢神经系统,但是具体机制尚不清楚。

glucagon   英 /'gluːkəg(ə)n; -gɒn/

释    义   n. [生化] 胰高血糖素;[生化] 胰增血糖素;高血糖因子

例    句   Here we examined the direct effects of glucagon on regulation of hepatic and intestinal lipoprotein metabolism in humans.本研究中我们观察了胰高血糖素在调节人类肝脏和肠道脂蛋白代谢的直接作用。

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