Safety and efficacy of adjuvant Sotagliflozin therapy in patients with T1D - an update and systematic review and meta-analysis.

IF 3.9 2区医学 Q2 ENDOCRINOLOGY & METABOLISM

Frontiers in Endocrinology Pub Date : 2025-06-03 eCollection Date: 2025-01-01 DOI:10.3389/fendo.2025.1506652

Yunzhen Lei, Shanshan Yao, Zhenglong Wang, Qianxian Tu, Zhengqiang Yuan, Qianfeng Jiang

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引用次数: 0

Abstract

Objective: This meta-analysis aims to assess the safety and efficacy of Sotagliflozin in patients with type 1 diabetes (T1D).

Methods: Data on target organ protection, blood glucose levels, blood pressure, weight, insulin usage, and adverse events (AEs) associated with Sotagliflozin in the treatment of T1D were collected from databases including PubMed, Scopus, Web of Science, Embase, and the Cochrane Library. The search period extended until February 21, 2024, and included studies were restricted to randomized controlled trials (RCTs) investigating Sotagliflozin for T1D. The meta-analysis was performed using Stata 14 and RevMan 5.4.

Results: A total of 12 randomized controlled trials were included in the analysis, with treatment durations ranging from 14 to 52 weeks. Sotagliflozin, when used in combination with insulin therapy, resulted in significant reductions in cardiovascular disease (CVD) risk (-6.38%; 95% CI: -7.63 to -5.1; P < 0.05) and end-stage kidney disease (ESKD) risk (-5.0%; 95% CI: -7.62 to -2.3; P < 0.05). Additionally, Sotagliflozin significantly reduced blood glucose, blood pressure, and body weight, with these effects showing dose- and duration-dependent trends. Regarding adverse effects, the combination of insulin and Sotagliflozin was associated with an increased incidence of genital infections (Sotagliflozin group: 8% vs. control: 2%) but a reduced risk of fractures (Sotagliflozin group: 1% vs. control: 2%). No statistically significant differences were observed between the two groups for other outcomes, including diabetic ketoacidosis (DKA), hypoglycemia, mortality, cancer, nausea, diarrhea, urinary tract infections, or liver and kidney function impairment.

Conclusion: In T1D patients, Sotagliflozin adjunct therapy improves blood glycemia, stabilizes blood pressure, and reduces cardiovascular risk factors. It also shows potential in lowering fracture risk, but the risk of DKA requires further clinical validation.

Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/#joinuppage, identifier CRD42023467427.

查看原文本刊更多论文

索他列净辅助治疗T1D患者的安全性和有效性——一项最新的系统综述和荟萃分析。

目的：本荟萃分析旨在评估Sotagliflozin治疗1型糖尿病（T1D）患者的安全性和有效性。方法：从PubMed、Scopus、Web of Science、Embase和Cochrane Library等数据库收集与Sotagliflozin治疗T1D相关的靶器官保护、血糖水平、血压、体重、胰岛素使用和不良事件（ae）的数据。检索期延长至2024年2月21日，纳入的研究仅限于调查Sotagliflozin治疗T1D的随机对照试验（rct）。meta分析采用Stata 14和RevMan 5.4进行。结果：共纳入12项随机对照试验，治疗时间为14 ~ 52周。当Sotagliflozin与胰岛素治疗联合使用时，导致心血管疾病（CVD）风险显著降低(-6.38%；95% CI: -7.63 ~ -5.1；P < 0.05)和终末期肾病（ESKD）风险(-5.0%；95% CI: -7.62 ~ -2.3；P < 0.05)。此外，Sotagliflozin显著降低血糖、血压和体重，这些效果显示出剂量和持续时间依赖的趋势。关于不良反应，胰岛素和Sotagliflozin联合使用与生殖器感染发生率增加相关（Sotagliflozin组：8%，对照组：2%），但骨折风险降低（Sotagliflozin组：1%，对照组：2%）。两组之间的其他结局，包括糖尿病酮症酸中毒（DKA）、低血糖、死亡率、癌症、恶心、腹泻、尿路感染或肝肾功能损害，没有统计学上的显著差异。结论：在T1D患者中，索他列净辅助治疗可改善血糖，稳定血压，降低心血管危险因素。它也显示出降低骨折风险的潜力，但DKA的风险需要进一步的临床验证。系统综述注册：https://www.crd.york.ac.uk/PROSPERO/#joinuppage，标识符CRD42023467427。

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来源期刊

Frontiers in Endocrinology Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

5.70

自引率

9.60%

发文量

3023

审稿时长

14 weeks

期刊介绍： Frontiers in Endocrinology is a field journal of the "Frontiers in" journal series. In today’s world, endocrinology is becoming increasingly important as it underlies many of the challenges societies face - from obesity and diabetes to reproduction, population control and aging. Endocrinology covers a broad field from basic molecular and cellular communication through to clinical care and some of the most crucial public health issues. The journal, thus, welcomes outstanding contributions in any domain of endocrinology. Frontiers in Endocrinology publishes articles on the most outstanding discoveries across a wide research spectrum of Endocrinology. The mission of Frontiers in Endocrinology is to bring all relevant Endocrinology areas together on a single platform.