Wang Hong, Zu Quannan, Lu Ming, Chen Rongfa, Tang Zhangui, Yang Zhiren
Department of Cardiology, The Peoples Hospital of Guangxi Zhuang Autonomous Region, Nanning, 530021, Guangxi, People's Republic of China.
College of Management and Economics, Tianjin University, Tianjin, 300072, People's Republic of China.
Diabetes Ther. 2025 Mar;16(3):485-498. doi: 10.1007/s13300-025-01696-w. Epub 2025 Jan 30.
Scientific publications have shown sodium-glucose co-transporter-2 (SGLT2) inhibitors to have several beneficial effects in patients with complex type 2 diabetes mellitus (T2DM). However, sodium-glucose co-transporter-1 (SGLT-1) inhibitor is still under investigation in clinical trials. Recently, a dual inhibitor of sodium-glucose co-transporter (SGLT1/2), sotagliflozin, has been approved for use in patients with T2DM. In this analysis, we aimed to systematically compare the cardiovascular outcomes in patients with complex T2DM who were treated with the newly approved dual (SGLT 1 and 2) inhibitor sotagliflozin.
Electronic databases, including Embase, MEDLINE, http://www.
gov , Web of Science, Google Scholar, the Cochrane database, and reference lists of relevant publications, were searched for publications comparing the novel SGLT1/2 inhibitor versus placebo for the treatment of patients with complex T2DM. The primary endpoint, including total number of deaths from cardiovascular causes, hospitalization for heart failure, and urgent visits for heart failure, death from cardiovascular causes, cardiac mortality, hospitalization for heart failure, non-fatal myocardial infarction, and total number of cardiac events, were considered as the endpoints in this analysis. The RevMan software version 5.4 was used to carry out the statistical analysis. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent the data following analysis.
A total of 13,054 participants enrolled between 2017 and 2020 were included in this analysis, with 6734 participants assigned to sotagliflozin and 6320 assigned to placebo. The results of this analysis showed that the primary endpoint was significantly in favor of sotagliflozin with (RR: 0.73, 95% CI 0.67-0.80; P = 0.00001). Hospitalization for heart failure (RR: 0.67, 95% CI 0.60-0.75; P = 0.00001) and the total number of cardiac events (RR: 0.73, 95% CI 0.67-0.79; P = 0.00001) were also significantly lower with sotagliflozin when compared to placebo in these patients with complex T2DM. However, the risk for cardiovascular mortality and non-fatal myocardial infarction were not significantly different with (RR: 0.91, 95% CI 0.76-1.09; P = 0.31) and (RR: 0.92, 95% CI 0.27-3.12; P = 0.89), respectively.
Cardiovascular outcomes, including the total number of adverse cardiac events and hospitalization for heart failure, were significantly reduced with the newly approved SGLT1/2 inhibitor sotagliflozin apparently showing its cardiovascular efficacy in patients with complex T2DM. Future trials with larger sample sizes and a longer follow-up time could possibly confirm this hypothesis.
科学出版物表明，钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂对复杂2型糖尿病（T2DM）患者有多种有益作用。然而，钠-葡萄糖协同转运蛋白1（SGLT-1）抑制剂仍在临床试验中研究。最近，一种钠-葡萄糖协同转运蛋白（SGLT1/2）双重抑制剂索格列净已被批准用于T2DM患者。在本分析中，我们旨在系统比较接受新批准的双重（SGLT 1和2）抑制剂索格列净治疗的复杂T2DM患者的心血管结局。
本分析纳入了2017年至2020年期间登记的共13054名参与者，其中6734名参与者被分配到索格列净组，6320名被分配到安慰剂组。该分析结果显示，主要终点显著有利于索格列净（RR：0.73，95%CI 0.67 - 0.80；P = 0.00001）。与安慰剂相比，这些复杂T2DM患者使用索格列净时因心力衰竭住院（RR：0.67，95%CI 0.60 - 0.75；P = 0.00001）和心脏事件总数（RR：0.73，95%CI 0.67 - 0.79；P = 0.00001）也显著更低。然而，心血管死亡率和非致命性心肌梗死的风险无显著差异，分别为（RR：0.91，95%CI 0.76 - 1.09；P = 0.31）和（RR：0.92，95%CI 0.27 - 3.12；P = 0.89）。
新批准的SGLT1/2抑制剂索格列净显著降低了心血管结局，包括不良心脏事件总数和因心力衰竭住院，显然在复杂T2DM患者中显示出其心血管疗效。未来更大样本量和更长随访时间的试验可能会证实这一假设。
