口服塞马格卢提德对2型糖尿病患者结局的影响:来自SOUL随机试验的结果
Johannes F E Mann1,2, Nikolaus Marx3, John E Deanfield4
1KfH Kidney Center, Munich, Germany.
Diabetes care
|December 11, 2025
概括
在2型糖尿病和心血管或脏疾病患者中,口服赛马格卢提德并没有显著减少不良结局. 然而,它确实减缓了估计的淋巴细胞过率 (eGFR) 的下降.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
背景情况:
- 2型糖尿病 (T2D) 和其并发症,包括动脉样硬化心血管疾病 (ASCVD) 和慢性病 (CKD),对健康造成重大负担.
- 了解这种高风险人群中新型治疗剂对脏的影响对于临床实践至关重要.
研究的目的:
- 调查口服赛马格卢提德对T2D和已确定的ASCVD和/或CKD患者结局的影响.
- 评估口服赛马格卢提德对复合结局的影响,以及估计膜过率 (eGFR) 降低的速度.
主要方法:
- SOUL试验是一项双盲,随机对照试验,涉及9,650名患有T2D和ASCVD和/或CKD的参与者.
- 参与者接受了口服赛马格卢提德或安慰剂,平均随访时间为47.5个月.
- 预先规定的结结果包括五点复合,四点复合和年度eGFR下降.
主要成果:
- 与安慰剂相比,口服赛马格卢提德并没有显著降低五点复合结局 (HR 0.91;P=0.19) 或四点复合结局 (HR 0.86;P=0.22) 的风险.
- 然而,口服塞马格卢提德显著减缓了每年平均EGFR下降的速度 (塞马格卢提德-1.67mL/min/1.73m2与安慰剂 -2.06mL/min/1.73m2;P<0.0001).
- 这些对的益处在各种子组中观察到,包括那些基线eGFR<60mL/min/1.73m2的子组.
结论:
- 在患有T2D和ASCVD和/或CKD的患者中,口服赛马格卢提德并没有显著改变主要的脏不良事件.
- 口服赛马格卢提德在减缓这一群体EGFR下降速度方面显示出显著的益处.
- 这些发现表明,口服赛马格卢提德在维护功能方面可能发挥作用,特别是在减缓疾病进展方面.
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