口服司美格鲁肽对 2 型糖尿病合并已确诊的动脉粥样硬化性心血管疾病和/或慢性肾脏病患者心血管结局的影响：一项随机试验 SOUL 的设计和基线特征。
Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL, a randomized trial.
机构信息
University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, Texas, USA.
Department of Internal Medicine, Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, Michigan, USA.
出版信息
Diabetes Obes Metab. 2023 Jul;25(7):1932-1941. doi: 10.1111/dom.15058. Epub 2023 Apr 11.
AIM
To describe the design of the SOUL trial (Semaglutide cardiOvascular oUtcomes triaL) and the baseline clinical data of its participants.
MATERIALS AND METHODS
In SOUL, the effects of oral semaglutide, the first oral glucagon-like peptide-1 receptor agonist, on the risk of cardiovascular (CV) events in individuals with type 2 diabetes and established atherosclerotic CV disease (ASCVD) and/or chronic kidney disease (CKD) will be assessed. SOUL is a randomized, double-blind, parallel-group, placebo-controlled CV outcomes trial comparing oral semaglutide (14 mg once daily) with placebo, both in addition to standard of care, in individuals aged ≥50 years with type 2 diabetes and evidence of ASCVD (coronary artery disease [CAD], cerebrovascular disease, symptomatic peripheral arterial disease [PAD]) and/or CKD (estimated glomerular filtration rate <60 mL/min/1.73 m ). The primary outcome is time from randomization to first occurrence of a major adverse CV event (MACE; a composite of CV death, nonfatal myocardial infarction or nonfatal stroke). This event-driven trial will continue until 1225 first adjudication-confirmed MACEs have occurred. Enrolment has been completed.
RESULTS
Overall, 9650 participants were enrolled between June 17, 2019 and March 24, 2021 (men 71.1%, White ethnicity 68.9%, mean age 66.1 years, diabetes duration 15.4 years, body mass index 31.1 kg/m , glycated haemoglobin 63.5 mmol/mol [8.0%]). The most frequently used antihyperglycaemic medications at baseline were metformin (75.7%), insulin and insulin analogues (50.5%), sulphonylureas (29.1%), sodium-glucose cotransporter-2 inhibitors (26.7%) and dipeptidyl peptidase-4 inhibitors (23.0%). At randomization, 70.7% of participants had CAD, 42.3% had CKD, 21.1% had cerebrovascular disease and 15.7% had symptomatic PAD (categories not mutually exclusive). Prevalent heart failure was reported in 23.0% of participants.
CONCLUSION
SOUL will provide evidence regarding the CV effects of oral semaglutide in individuals with type 2 diabetes and established ASCVD and/or CKD.
目的
描述 SOUL 试验（司美格鲁肽心血管结局试验）的设计以及参与者的基线临床数据。
材料和方法
在 SOUL 试验中，将评估口服司美格鲁肽（首个口服胰高血糖素样肽-1 受体激动剂）对患有 2 型糖尿病和已确诊动脉粥样硬化性心血管疾病（ASCVD）和/或慢性肾脏病（CKD）的个体心血管（CV）事件风险的影响。SOUL 是一项随机、双盲、平行组、安慰剂对照的 CV 结局试验，将比较口服司美格鲁肽（每日 14mg，一次）与安慰剂，均在年龄≥50 岁、患有 2 型糖尿病且有 ASCVD（冠心病[CAD]、脑血管疾病、有症状的外周动脉疾病[PAD]）和/或 CKD（估算肾小球滤过率<60mL/min/1.73m ）证据的个体中，在标准治疗的基础上进行。主要结局是从随机分组到首次发生主要不良 CV 事件（MACE；CV 死亡、非致死性心肌梗死或非致死性卒中的复合事件）的时间。该事件驱动试验将持续至发生 1225 例首次裁决确认的 MACE 事件。入组已经完成。
结果
总体而言，2019 年 6 月 17 日至 2021 年 3 月 24 日期间共纳入 9650 名参与者（男性占 71.1%，白种人占 68.9%，平均年龄 66.1 岁，糖尿病病程 15.4 年，体重指数 31.1kg/m ，糖化血红蛋白 63.5mmol/mol[8.0%]）。基线时最常使用的抗高血糖药物为二甲双胍（75.7%）、胰岛素及其类似物（50.5%）、磺脲类（29.1%）、钠-葡萄糖共转运蛋白 2 抑制剂（26.7%）和二肽基肽酶-4 抑制剂（23.0%）。随机分组时，70.7%的参与者有 CAD，42.3%有 CKD，21.1%有脑血管疾病，15.7%有有症状的 PAD（类别不互斥）。23.0%的参与者报告有心力衰竭。
结论
SOUL 将提供关于口服司美格鲁肽在患有 2 型糖尿病和已确诊 ASCVD 和/或 CKD 的个体中的 CV 效果的证据。
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