Treatment-duration-wise harm profile of insulin-sodium-glucose co-transporter inhibitor co-treatment in type 1 diabetes mellitus patients.

IF 1.8 Q4 ENDOCRINOLOGY & METABOLISM Journal of Diabetes and Metabolic Disorders Pub Date : 2023-02-15 eCollection Date: 2023-06-01 DOI:10.1007/s40200-023-01192-7

Sumanta Saha, Sujata Saha, Mohan Gayen

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Abstract

Background: The treatment duration of insulin-sodium-glucose co-transporter inhibitors (SGLTis) co-treatment of type 1 diabetes mellitus (T1DM) patients in randomized controlled trials (RCTs) varies by 1-52 weeks. Henceforth, treatment duration-wise, we compared the following insulin-treatment adjuncts- mega- versus low-dose SGLTis, SGLTis versus placebo, and different SGLTi dosages.

Method: Double-blinded RCTs reporting the above were searched (using terms like insulin-dependent, "juvenile-onset diabetes," and "sodium glucose cotransport*") in the PubMed, Embase, and Scopus databases and appraised using a Cochrane tool. The risks across different SGLTi-dosages were compared using network meta-analysis. Random-effect pairwise meta-analysis was performed for the remaining harm juxtapositions. Meta-analyses were performed for the following treatment durations- < 4 weeks, 4 to < 24 weeks, and ≥ 24 weeks. For meta-analysis and certainty of evidence assessment, we used the Stata statistical software and the GRADE method, respectively.

Results: A total of 15 (low risks of bias) studies sourcing data from about 7,330 T1DM patients were reviewed. Meta-analysis findings of ≥ 24 weeks long trials were- a. SGLTi-insulin co-treatment increased the genital infection (GI) (RR: 3.51; 95% CI: 2.59, 4.77), diabetic ketoacidosis (DKA) and (RR: 3.25; 95% CI:1.29, 8.16), and serious side effects (RR: 1.43; 95% CI: 1.05, 1.94) risk. b. SGLT2i-insulin increased the GI risk (RR: 3.77; 95% CI: 2.31, 6.16; high-quality evidence). c. Sotagliflozin-insulin increased the GI (RR: 3.36; 95% CI: 2.28, 4.96) and DKA (RR: 6.69; 95% CI: 2.75, 16.32) risk (both high-quality evidence). Compared to low-dose, megadose SGLTi treatment for 4 to < 24 weeks increased the GI risk. The remaining analyses were not statistically significantly different.

Conclusion: On moderate to long-term treatment (24-52 weeks) of T1DM patients, insulin-SGLT2i co-treatment was associated with GI risk, and insulin-sotagliflozin co-treatment was associated with DKA and GI risk.

Supplementary information: The online version contains supplementary material available at 10.1007/s40200-023-01192-7.

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胰岛素-钠-葡萄糖共转运蛋白抑制剂联合治疗1型糖尿病患者的治疗持续时间危害概况。

背景：在随机对照试验（RCTs）中，胰岛素-钠-葡萄糖共转运蛋白抑制剂（SGLTis）联合治疗1型糖尿病（T1DM）患者的治疗持续时间为1-52周。此后，在治疗持续时间方面，我们比较了以下胰岛素治疗辅助药物——大剂量与低剂量SGLTi、SGLTis与安慰剂以及不同的SGLTi剂量。方法：在PubMed、Embase和Scopus数据库中搜索报告上述情况的双盲随机对照试验（使用胰岛素依赖性、“青少年糖尿病”和“钠-葡萄糖协同转运*”等术语），并使用Cochrane工具进行评估。使用网络荟萃分析比较不同SGLTi剂量的风险。对剩余的危害并置进行随机效应成对荟萃分析。对以下治疗持续时间进行荟萃分析- 结果：共回顾了15项（低偏倚风险）研究，这些研究的数据来源于约7330名T1DM患者。的Meta分析结果 ≥ 为期24周的试验是-a。SGLTi胰岛素联合治疗增加了生殖器感染（GI）（RR:3.51；95%CI:2.59，4.77）、糖尿病酮症酸中毒（DKA）和（RR:3.25；95%CI:1.29，8.16）以及严重副作用（RR:1.43；95%CI:1.05，1.94）的风险。b.SGLT2i胰岛素增加胃肠道风险（RR:3.77；95%CI:2.31，6.16；高质量证据）。c.索塔列嗪胰岛素增加了GI（RR:3.36；95%CI:2.28，4.96）和DKA（RR:6.69；95%CI:2.75，16.32）风险（均为高质量证据）。与低剂量、大剂量SGLTi治疗相比结论：在T1DM患者的中长期治疗（24-52周）中，胰岛素-SGLT2i联合治疗与胃肠道风险相关，胰岛素-索塔列嗪联合治疗与DKA和胃肠道风险有关。补充信息：在线版本包含补充材料，网址为10.1007/s40200-023-01192-7。

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来源期刊

Journal of Diabetes and Metabolic Disorders Medicine-Internal Medicine

CiteScore

4.80

自引率

3.60%

发文量

210

期刊介绍： Journal of Diabetes & Metabolic Disorders is a peer reviewed journal which publishes original clinical and translational articles and reviews in the field of endocrinology and provides a forum of debate of the highest quality on these issues. Topics of interest include, but are not limited to, diabetes, lipid disorders, metabolic disorders, osteoporosis, interdisciplinary practices in endocrinology, cardiovascular and metabolic risk, aging research, obesity, traditional medicine, pychosomatic research, behavioral medicine, ethics and evidence-based practices.As of Jan 2018 the journal is published by Springer as a hybrid journal with no article processing charges. All articles published before 2018 are available free of charge on springerlink.Unofficial 2017 2-year Impact Factor: 1.816.