Fadini Gian Paolo
Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
Diabetes Ther. 2025 Aug 31. doi: 10.1007/s13300-025-01784-x.
Despite advances in cardiovascular risk reduction in type 2 diabetes (T2D), a persistent gap remains compared to individuals without diabetes. Glucagon-like peptide-1 receptor agonists (GLP-1RA) have provided consistent cardiovascular benefits. With more cardiovascular protective agents available for diabetes management, their incremental effect may be nearing a ceiling. The SURPASS-CVOT trial innovatively compared the dual GIP/GLP-1RA tirzepatide with the selective GLP-1RA dulaglutide, demonstrating noninferiority for major adverse cardiovascular events (MACE; HR 0.92; 95.3% CI 0.83-1.01; p = 0.086) and suggesting a potential 28% MACE risk reduction versus an imputed placebo. However, superiority over dulaglutide was narrowly missed. Despite greater improvements in glycemia (0.8% greater HbA1c reduction) and weight (7% greater weight loss), tirzepatide appeared to confer limited incremental cardiovascular benefit, raising questions about mechanism saturation or trial design constraints. Exploratory analyses showed promising benefits on mortality and renal function but require cautious interpretation. The trial's active comparator/imputed placebo design reflects an evolving ethical and therapeutic landscape in diabetes care. Whether dual incretin receptor agonism can meaningfully exceed current cardioprotective thresholds remains uncertain. By now, we may need new paradigms to overcome what may turn out to be a therapeutic ceiling for cardiovascular protection in the T2D population.
尽管2型糖尿病(T2D)患者在心血管风险降低方面取得了进展,但与非糖尿病个体相比,仍存在持续差距。胰高血糖素样肽-1受体激动剂(GLP-1RA)已带来持续的心血管益处。随着更多心血管保护药物可用于糖尿病管理,它们的增量效应可能已接近上限。SURPASS-CVOT试验创新性地将双重GIP/GLP-1RA替尔泊肽与选择性GLP-1RA度拉糖肽进行了比较,结果显示在主要不良心血管事件(MACE)方面非劣效(HR 0.92;95.3%CI 0.83-1.01;p = 0.086),提示与虚拟安慰剂相比MACE风险可能降低28%。然而,略未达到优于度拉糖肽的效果。尽管替尔泊肽在血糖控制(糖化血红蛋白降低幅度大0.8%)和体重减轻(体重减轻幅度大7%)方面有更大改善,但似乎带来的心血管增量益处有限,这引发了关于机制饱和或试验设计局限性的问题。探索性分析显示在死亡率和肾功能方面有可观益处,但需要谨慎解读。该试验的活性对照/虚拟安慰剂设计反映了糖尿病治疗中不断演变的伦理和治疗格局。双重肠促胰岛素受体激动作用能否显著超过当前的心脏保护阈值仍不确定。到目前为止,我们可能需要新的范例来克服T2D人群心血管保护可能出现的治疗上限。