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在2型糖尿病患者中,口服赛马格卢提德和心力衰竭的结果:对SOUL随机临床试验的二次分析
Rodica Pop-Busui1,2, Søren Rasmussen3, John E Deanfield4
1Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Medicine, Oregon Health & Science University, Portland.
JAMA internal medicine
|February 2, 2026
概括
在2型糖尿病 (T2D) 患者中,口服赛马格卢降低了心力衰竭 (HF) 事件,并且有HF病史. 这项研究没有发现严重不良事件的风险增加,支持其在T2D患者中对HF的潜在益处.
科学领域:
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 心力衰竭 (HF) 是2型糖尿病 (T2D) 的常见并发症.
- 口服塞马格卢提德对T2D患者的HF结局的影响 已确定的心血管疾病以前是未知的.
研究的目的:
- 评估口服赛马格卢提德对高风暴事件,主要不良心血管 (CV) 事件 (MACE) 和安全性的影响.
- 在基线时评估具有和没有HF病史的参与者的结果.
主要方法:
- 双盲,安慰剂控制的3b期SOUL随机临床试验的二次分析.
- 包括9650名患有T2D和动脉样性心血管疾病和/或慢性病的参与者,按HF病史分层.
- 评估综合性HF结果 (HF住院,紧急HF访问,CV死亡) 和MACE.
主要成果:
- 口服塞马格卢提德在参与者中减少了22%的HF事件 (HR 0.78),这些参与者有HF病史 (P相互作用=0.06).
- 这种益处在HF中更明显,其喷射分数保留 (HR 0.59).
- 在没有先前HF的人群中,没有明显减少HF事件 (HR 1.01). 在不同组中,MACE风险降低一致.
结论:
- 口服塞马格卢提德的使用与T2D患者的HF事件减少有关,这些患者有HF病史.
- 没有观察到严重不良事件的风险增加.
- 这些发现支持口服赛马格卢提德在减少T2D和并发性HF患者的HF事件方面的潜在益处.
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