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Erschienen in: Journal of Diabetes & Metabolic Disorders 1/2023

15.02.2023 | Research article

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

verfasst von: Sumanta Saha, Sujata Saha, Mohan Gayen

Erschienen in: Journal of Diabetes & Metabolic Disorders | Ausgabe 1/2023

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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.
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Literatur
3.
Zurück zum Zitat Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med [Internet]. 1993;329:977–86. Available from: http://www.ncbi.nlm.nih.gov/pubmed/8366922. Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med [Internet]. 1993;329:977–86. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​8366922.
4.
15.
Zurück zum Zitat Watada H, Shiramoto M, Ueda S, Tang W, Asano M, Thorén F, et al. Pharmacokinetics and pharmacodynamics of dapagliflozin in combination with insulin in Japanese patients with type 1 diabetes. Diabetes, Obes Metab [Internet]. 2019;21:876–82. Available from: http://doi.wiley.com/10.1111/dom.13593. Watada H, Shiramoto M, Ueda S, Tang W, Asano M, Thorén F, et al. Pharmacokinetics and pharmacodynamics of dapagliflozin in combination with insulin in Japanese patients with type 1 diabetes. Diabetes, Obes Metab [Internet]. 2019;21:876–82. Available from: http://​doi.​wiley.​com/​10.​1111/​dom.​13593.
21.
Zurück zum Zitat Hutton B, Salanti G, Caldwell DM, Chaimani A, Schmid CH, Cameron C, et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med [Internet]. 2015;162:777–84. Available from: https://www.acpjournals.org/doi/abs/10.7326/M14-2385. Hutton B, Salanti G, Caldwell DM, Chaimani A, Schmid CH, Cameron C, et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med [Internet]. 2015;162:777–84. Available from: https://​www.​acpjournals.​org/​doi/​abs/​10.​7326/​M14-2385.
26.
Zurück zum Zitat Saha S, Saha S. A systematic review and meta-analysis of randomised controlled trials, contrasting the safety profile between sodium-glucose cotransporter-2 inhibitors and placebo in type 1 diabetes mellitus patients. Int J Diabetes Metab [Internet]. S. Karger AG; 2019;25:62–73. Available from: https://www.karger.com/Article/FullText/506366. Saha S, Saha S. A systematic review and meta-analysis of randomised controlled trials, contrasting the safety profile between sodium-glucose cotransporter-2 inhibitors and placebo in type 1 diabetes mellitus patients. Int J Diabetes Metab [Internet]. S. Karger AG; 2019;25:62–73. Available from: https://​www.​karger.​com/​Article/​FullText/​506366.
28.
Zurück zum Zitat Saha S, Saha S. The comparison of efficacy and safety between different doses of empagliflozin in insulin-treated type 1 diabetes mellitus patients: a systematic review and meta-analysis protocol. J Diabetes Metab Disord [Internet]. 2020;19:545–50. Available from: http://www.ncbi.nlm.nih.gov/pubmed/32550206. Saha S, Saha S. The comparison of efficacy and safety between different doses of empagliflozin in insulin-treated type 1 diabetes mellitus patients: a systematic review and meta-analysis protocol. J Diabetes Metab Disord [Internet]. 2020;19:545–50. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​32550206.
29.
Zurück zum Zitat Saha S, Saha S. A systematic review and meta-analysis of randomized controlled trials, juxtaposing the control of glycemia and blood pressure between large dose empagliflozin and placebo among type 1 diabetes patients. Int J Health Sci (Qassim) [Internet]. 2020;14:40–52. Available from: http://www.ncbi.nlm.nih.gov/pubmed/32206059. Saha S, Saha S. A systematic review and meta-analysis of randomized controlled trials, juxtaposing the control of glycemia and blood pressure between large dose empagliflozin and placebo among type 1 diabetes patients. Int J Health Sci (Qassim) [Internet]. 2020;14:40–52. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​32206059.
32.
Zurück zum Zitat Saha S. Death and invasive mechanical ventilation risk in hospitalized COVID-19 patients treated with anti-SARS-CoV-2 monoclonal antibodies and/or antiviral agents: A systematic review and network meta-analysis protocol. Chen RJ, editor. PLoS One [Internet]. 2022;17:e0270196. Available from: https://dx.plos.org/10.1371/journal.pone.0270196. Saha S. Death and invasive mechanical ventilation risk in hospitalized COVID-19 patients treated with anti-SARS-CoV-2 monoclonal antibodies and/or antiviral agents: A systematic review and network meta-analysis protocol. Chen RJ, editor. PLoS One [Internet]. 2022;17:e0270196. Available from: https://​dx.​plos.​org/​10.​1371/​journal.​pone.​0270196.
33.
Zurück zum Zitat Saha S, Saha S. The effects of prenatal dietary supplements on blood glucose and lipid metabolism in gestational diabetes mellitus patients: A systematic review and network meta-analysis protocol of randomized controlled trials. Laganà AS, editor. PLoS One [Internet]. 2022;17:e0267854. Available from: https://dx.plos.org/10.1371/journal.pone.0267854. Saha S, Saha S. The effects of prenatal dietary supplements on blood glucose and lipid metabolism in gestational diabetes mellitus patients: A systematic review and network meta-analysis protocol of randomized controlled trials. Laganà AS, editor. PLoS One [Internet]. 2022;17:e0267854. Available from: https://​dx.​plos.​org/​10.​1371/​journal.​pone.​0267854.
34.
Zurück zum Zitat Saha S. Comparative effectiveness of adjunct non-pharmacological interventions on maternal and neonatal outcomes in gestational diabetes mellitus patients: A systematic review and network meta-analysis protocol of randomized controlled trials. Grammatikopoulou MG, editor. PLoS One [Internet]. 2022;17:e0263336. Available from: https://dx.plos.org/10.1371/journal.pone.0263336. Saha S. Comparative effectiveness of adjunct non-pharmacological interventions on maternal and neonatal outcomes in gestational diabetes mellitus patients: A systematic review and network meta-analysis protocol of randomized controlled trials. Grammatikopoulou MG, editor. PLoS One [Internet]. 2022;17:e0263336. Available from: https://​dx.​plos.​org/​10.​1371/​journal.​pone.​0263336.
36.
Zurück zum Zitat Chaimani A, Caldwell DM, Li T, Higgins JP, Salanti G. Chapter 11: Undertaking network meta-analyses. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). [Internet]. Cochrane Handb. Syst. Rev. Interv. version 6.2 (updated Febr. 2021). Cochrane, 2021. Available from: www.training.cochrane.org/handbook. Chaimani A, Caldwell DM, Li T, Higgins JP, Salanti G. Chapter 11: Undertaking network meta-analyses. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). [Internet]. Cochrane Handb. Syst. Rev. Interv. version 6.2 (updated Febr. 2021). Cochrane, 2021. Available from: www.​training.​cochrane.​org/​handbook.
40.
Zurück zum Zitat Salanti G. Indirect and mixed-treatment comparison, network, or multiple-treatments meta-analysis: many names, many benefits, many concerns for the next generation evidence synthesis tool. Res Synth Methods [Internet]. 2012;3:80–97. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26062083. Salanti G. Indirect and mixed-treatment comparison, network, or multiple-treatments meta-analysis: many names, many benefits, many concerns for the next generation evidence synthesis tool. Res Synth Methods [Internet]. 2012;3:80–97. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​26062083.
44.
Zurück zum Zitat Schünemann H, Brożek J, Guyatt G, Oxman A, Editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. GRADE Work Group, 2013 [Internet]. 2013; Available from: guidelinedevelopment.org/handbook. Schünemann H, Brożek J, Guyatt G, Oxman A, Editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. GRADE Work Group, 2013 [Internet]. 2013; Available from: guidelinedevelopment.org/handbook.
50.
Zurück zum Zitat Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschöpe D, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. lancet Diabetes Endocrinol [Internet]. 2017;5:864–76. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28919061. Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschöpe D, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. lancet Diabetes Endocrinol [Internet]. 2017;5:864–76. Available from: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​28919061.
52.
Zurück zum Zitat Shimada A, Hanafusa T, Yasui A, Lee G, Taneda Y, Sarashina A, et al. Empagliflozin as adjunct to insulin in Japanese participants with type 1 diabetes: Results of a 4-week, double-blind, randomized, placebo-controlled phase 2 trial. Diabetes, Obes Metab [Internet]. 2018;20:2190–9. Available from: http://doi.wiley.com/10.1111/dom.13351. Shimada A, Hanafusa T, Yasui A, Lee G, Taneda Y, Sarashina A, et al. Empagliflozin as adjunct to insulin in Japanese participants with type 1 diabetes: Results of a 4-week, double-blind, randomized, placebo-controlled phase 2 trial. Diabetes, Obes Metab [Internet]. 2018;20:2190–9. Available from: http://​doi.​wiley.​com/​10.​1111/​dom.​13351.
56.
Zurück zum Zitat Pieber TR, Famulla S, Eilbracht J, Cescutti J, Soleymanlou N, Johansen OE, et al. Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial (EASE-1). Diabetes, Obes Metab [Internet]. 2015;17:928–35. Available from: http://doi.wiley.com/10.1111/dom.12494. Pieber TR, Famulla S, Eilbracht J, Cescutti J, Soleymanlou N, Johansen OE, et al. Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial (EASE-1). Diabetes, Obes Metab [Internet]. 2015;17:928–35. Available from: http://​doi.​wiley.​com/​10.​1111/​dom.​12494.
62.
65.
Zurück zum Zitat Saha S. An appraisal of a systematic review and meta-analysis of randomized clinical trials on the efficacy and safety of sodium-glucose cotransporter-2 inhibitors as an adjunct to insulin therapy in type 1 diabetes patients. Int J Diabetes Metab [Internet]. S. Karger AG; 2019;25:162–162. Available from: https://www.karger.com/Article/FullText/502743. Saha S. An appraisal of a systematic review and meta-analysis of randomized clinical trials on the efficacy and safety of sodium-glucose cotransporter-2 inhibitors as an adjunct to insulin therapy in type 1 diabetes patients. Int J Diabetes Metab [Internet]. S. Karger AG; 2019;25:162–162. Available from: https://​www.​karger.​com/​Article/​FullText/​502743.
67.
Zurück zum Zitat Chen J, Fan F, Wang JY, Long Y, Gao CL, Stanton RC, et al. The efficacy and safety of SGLT2 inhibitors for adjunctive treatment of type 1 diabetes: a systematic review and meta-analysis. Sci Rep [Internet]. 2017;7:44128. Available from: http://www.nature.com/articles/srep44128. Chen J, Fan F, Wang JY, Long Y, Gao CL, Stanton RC, et al. The efficacy and safety of SGLT2 inhibitors for adjunctive treatment of type 1 diabetes: a systematic review and meta-analysis. Sci Rep [Internet]. 2017;7:44128. Available from: http://​www.​nature.​com/​articles/​srep44128.
Metadaten
Titel
Treatment-duration-wise harm profile of insulin-sodium-glucose co-transporter inhibitor co-treatment in type 1 diabetes mellitus patients
verfasst von
Sumanta Saha
Sujata Saha
Mohan Gayen
Publikationsdatum
15.02.2023
Verlag
Springer International Publishing
Erschienen in
Journal of Diabetes & Metabolic Disorders / Ausgabe 1/2023
Elektronische ISSN: 2251-6581
DOI
https://doi.org/10.1007/s40200-023-01192-7

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