在高风险的2型糖尿病中,口服塞马格卢提德和心血管结果
Darren K McGuire1,2, Nikolaus Marx3, Sharon L Mulvagh4
1University of Texas Southwestern Medical Center, Dallas.
The New England journal of medicine
|March 31, 2025
概括
在2型糖尿病和动脉样硬化心血管疾病或慢性病患者中,口服赛马格卢提德显著降低了主要的不良心血管事件. 这项研究证实了心血管方面的益处,而不会增加严重的不良事件.
科学领域:
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
- 腎臟病學 (nephrology) 是一種醫學專業.
背景情况:
- 口服塞马格卢提德是一种GLP-1受体激动剂,在患有高心血管风险的2型糖尿病患者中已经证明了心血管安全性.
- 对于患有2型糖尿病和动脉样硬化心血管疾病 (ASCVD) 或慢性病 (CKD) 的患者,需要进一步评估口服赛马格卢的心血管功效.
研究的目的:
- 评估口服赛马格卢提德在2型糖尿病患者和已确诊的ASCVD,CKD或两者的心血管疗效.
- 在这个高风险人群中评估口服塞马格卢提德的安全性.
主要方法:
- 一个双盲,安慰剂控制,事件驱动的优越性试验,涉及9650名50岁以上的参与者,患有2型糖尿病和ASCVD/CKD.
- 参与者每天接受口服赛马格卢提德 (高达14毫克) 或安慰剂,以及标准护理.
- 主要结局:主要不良心血管事件 (MACE);次要结局:主要病事件.
主要成果:
- 与安慰剂相比,口服赛马格卢提德可以将MACE的风险降低14% (HR 0.86;95%CI 0.77-0.96;P=0.006).
- 随着口服赛马格卢提德的使用,每100个人年中MACE的发生率为3.1次,与安慰剂相比为3.7次.
- 主要病事件没有显著差异;严重不良事件在两组之间相似 (47.9%与50.3%).
结论:
- 口服塞马格卢提德显著降低了2型糖尿病和ASCVD或CKD患者主要心血管不良事件的风险.
- 治疗没有增加严重不良事件的发生率,这表明安全性概况有利.
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