Kishimori Takefumi, Kato Takao, Wada Atsuyuki, Tani Akira, Yamaji Ryosuke, Koike Jumpei, Iwasaki Yoshihiro, Matsumoto Takehiro, Yagi Takafumi, Okada Masaharu
Department of Cardiovascular Medicine, Omi Medical Center, Kusatsu, Japan.
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine Faculty of Medicine, Kyoto, Japan
Open Heart. 2025 Jul 8;12(2):e003382. doi: 10.1136/openhrt-2025-003382.
Type 2 diabetes (T2D) and chronic kidney disease (CKD) significantly increase the risk of cardiovascular events, including death and heart failure (HF). The FLOW trial demonstrated that semaglutide reduces all-cause death, cardiovascular events and HF risk in patients with T2D and CKD. Since there is a difference in patient characteristics between clinical trials and real-world data, this study aims to investigate the association of semaglutide and all-cause death, acute HF or cardiovascular outcomes in patients with T2D and CKD using the data platform.
This multicentre retrospective observational study using TriNetX, a global healthcare data platform. We identified 1 151 750 patients aged ≥18 years with T2D and CKD diagnosed before 31 December 2020. Among these, 14 511 patients initiated semaglutide and 69 700 initiated sitagliptin between 1 January 2018 and 31 December 2020. After propensity score matching, 13 703 patients were included in each group. The primary outcome was the 3-year incidence of all-cause death. Secondary outcomes included acute HF, acute myocardial infarction and stroke.
The 3-year risk of all-cause death in the semaglutide group relative to the sitagliptin group was significantly lower (7.2% (943/13 703) vs 9.5% (1196/13 703); p<0.001; HR, 0.76; 95% CI, 0.70 to 0.83). Similarly, the semaglutide group was less likely to have acute HF (12.1% vs 13.1%; HR, 0.92; 95% CI, 0.86 to 0.98). However, the risks of acute myocardial infarction and stroke in the semaglutide group relative to the sitagliptin group were not significant (9.6% vs 9.5%; HR, 1.01; 95% CI, 0.93 to 1.09 in acute myocardial infarction, and 9.2% vs 9.0%; HR, 1.02; 95% CI, 0.94 to 1.10 in stroke).
In patients with T2D and CKD, semaglutide was associated with a lower 3-year risk of all-cause death compared with sitagliptin.
2型糖尿病（T2D）和慢性肾脏病（CKD）显著增加心血管事件风险，包括死亡和心力衰竭（HF）。FLOW试验表明，司美格鲁肽可降低T2D和CKD患者的全因死亡、心血管事件及HF风险。由于临床试验与真实世界数据中的患者特征存在差异，本研究旨在利用数据平台调查司美格鲁肽与T2D和CKD患者的全因死亡、急性HF或心血管结局之间的关联。
本多中心回顾性观察研究使用全球医疗数据平台TriNetX。我们识别出2020年12月31日前诊断为T2D和CKD的1151750例年龄≥18岁的患者。其中，14511例患者在2018年1月1日至2020年12月31日期间开始使用司美格鲁肽，69700例患者开始使用西格列汀。在倾向评分匹配后，每组纳入13703例患者。主要结局是全因死亡的3年发生率。次要结局包括急性HF、急性心肌梗死和中风。
与西格列汀组相比，司美格鲁肽组的3年全因死亡风险显著更低（7.2%（943/13703）对9.5%（1196/13703）；p<0.001；HR，0.76；95%CI，0.70至0.83）。同样，司美格鲁肽组发生急性HF的可能性更小（12.1%对13.1%；HR，0.92；95%CI，0.86至0.98）。然而，与西格列汀组相比，司美格鲁肽组的急性心肌梗死和中风风险无显著差异（急性心肌梗死：9.6%对9.5%；HR，1.01；95%CI，0.93至1.09；中风：9.2%对9.0%；HR，1.02；95%CI，0.94至1.10）。
在T2D和CKD患者中，与西格列汀相比，司美格鲁肽与更低的3年全因死亡风险相关。
