The "Can Semaglutide or eMpAgliflozin Stabilise coronary atHerosclerosis after Acute Coronary Syndrome (SMASH-ACS)” study in people with type 2 diabetes

This was an open-label, interventional study comparing semaglutide (a glucagon-like peptide-1 receptor agonist (GLP-1 RA) which was going to be self-administered subcutaneously by the patient (starting at 0.25mg/week, uptitrated on a monthly basis based on patient tolerance and at the direction of a physician, up to 1.0 mg/week as tolerated). The comparator was empagliflozin (a sodium-glucose co-transporter-2 (SGLT2) inhibitor), with a starting dose of 10mg daily, which could have been uptitrated to 25mg daily at 3 months at clinician discretion. Participants underwent baseline CT coronary angiogram (CTCA), and after continuing treatment for 12 month, underwent a CTCA at 12 months. Adherence was assessed by patient report at 1, 2, 3, 6, 9, and 12 months. The primary endpoint for this study was progression rates of low attenuation plaque under influence of GLP-1 RA as compared to SGLT2 inhibition as assessed by CT coronary angiography.

本研究为一项开放标签干预性研究，旨在对比司美格鲁肽（semaglutide，一种胰高糖素样肽-1受体激动剂（GLP-1 RA））与恩格列净（empagliflozin，一种钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂）的治疗效果。其中，受试者需自行皮下注射司美格鲁肽，起始剂量为每周0.25mg，每月根据患者耐受性并遵医嘱进行剂量递增，最大耐受剂量可达每周1.0mg；对照药物恩格列净的起始剂量为每日10mg，临床医生可根据诊疗判断在治疗3个月时将剂量调整为每日25mg。所有受试者均接受基线冠状动脉CT血管造影（CTCA）检查，并在持续治疗12个月后复查冠状动脉CT血管造影。分别于治疗第1、2、3、6、9、12个月通过患者报告评估用药依从性。本研究的主要终点为通过冠状动脉CT血管造影评估，相较于SGLT2抑制剂治疗，GLP-1 RA治疗下低衰减斑块的进展速率。