Hong Wang, Quannan Zu, Ming Lu, Rongfa Chen, Zhangui Tang, Zhiren Yang
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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.</p><p><strong>Methods: </strong>Electronic databases, including Embase, MEDLINE, http://www.</p><p><strong>Clinicaltrials: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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. 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引用次数: 0
摘要
科学出版物表明，钠-葡萄糖共转运蛋白-2 （SGLT2）抑制剂对复杂2型糖尿病（T2DM）患者有几种有益作用。然而，钠-葡萄糖共转运蛋白-1 （SGLT-1）抑制剂仍处于临床试验的研究阶段。最近，一种钠-葡萄糖共转运体（SGLT1/2）双重抑制剂sotagliflozin已被批准用于T2DM患者。在这项分析中，我们旨在系统地比较接受新批准的双重（sglt1和2）抑制剂sotagliflozin治疗的复杂T2DM患者的心血管结局。方法：检索电子数据库，包括Embase、MEDLINE、http://www.Clinicaltrials: gov、Web of Science、谷歌Scholar、Cochrane数据库和相关出版物的参考文献列表，以比较新型SGLT1/2抑制剂与安慰剂治疗复杂T2DM患者的出版物。主要终点，包括心血管原因死亡总人数、心力衰竭住院人数、心力衰竭紧急就诊人数、心血管原因死亡人数、心脏死亡率、心力衰竭住院人数、非致死性心肌梗死人数和心脏事件总数，被视为本分析的终点。采用RevMan 5.4版软件进行统计分析。采用95%置信区间（CI）的风险比（RR）表示分析后的数据。结果：在2017年至2020年期间，共有13054名参与者被纳入该分析，其中6734名参与者被分配给sotagliflozin， 6320名参与者被分配给安慰剂。本分析结果显示，主要终点显著支持索他列净(RR: 0.73, 95% CI 0.67-0.80；p = 0.00001)。心力衰竭住院(RR: 0.67, 95% CI 0.60-0.75；P = 0.00001)和总心脏事件数(RR: 0.73, 95% CI 0.67-0.79；P = 0.00001)在这些合并T2DM的患者中，与安慰剂相比，sotagliflozin也显著降低。然而，心血管死亡和非致死性心肌梗死的风险无显著差异(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)。结论：新批准的SGLT1/2抑制剂sotagliflozin明显显示其对复杂T2DM患者的心血管疗效，心血管结局（包括心脏不良事件总数和心力衰竭住院次数）显著降低。未来更大样本量的试验和更长的随访时间可能会证实这一假设。
Cardiovascular Outcomes in Patients with Complex Type 2 Diabetes Mellitus Treated with the Dual SGLT Inhibitor Sotagliflozin: A Meta-analysis.
Introduction: 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.
Methods: Electronic databases, including Embase, MEDLINE, http://www.
Clinicaltrials: 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.
Results: 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.
Conclusions: 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.
期刊介绍：
Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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