Effect of dual SGLT1/ SGLT2 inhibitor sotagliflozin on renal outcomes in type 1 and type 2 diabetes mellitus:  a systematic review and meta-analysis of randomised controlled trials

Maria A.  Bantounou; Panagiotis Sardellis; Rosa J.  Thuemmler; Daniel Black Boada; Justyna Kaczmarek; Ribeya Mahmood; Josip  Plascevic; Sam Phillips

doi:10.1111/dom.15364

Effect of dual SGLT1/ SGLT2 inhibitor sotagliflozin on renal outcomes in type 1 and type 2 diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials

Maria A. Bantounou^* (Corresponding Author)
, Panagiotis Sardellis
, Rosa J. Thuemmler
, Daniel Black Boada
, Justyna Kaczmarek
, Ribeya Mahmood
, Josip Plascevic
, Sam Phillips

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

2 Downloads (Pure)

Abstract

Aim
To investigate the renal safety profile of sotagliflozin, a novel sodium-glucose co-transporter-1 and -2 inhibitor, in patients with type 1 diabetes and type 2 diabetes, with or without renal impairment, as well as its efficacy in decreasing the risk of further renal events, with an emphasis on those with previous renal impairment.

Methods
Embase, Medline, CENTRAL and Scopus were searched from their inception until 24 April 2023 for randomized controlled trials that reported estimated glomerular filtration rate (eGFR), urinary albumin excretion or composite renal events (CRE). The Cochrane risk of bias 2 tool was used. Mean difference, relative risk (RR) and 95% confidence intervals were estimated (PROSPERO: CRD42023425583).

Results
Fourteen studies were included in this review (n = 17 574 participants; intervention n = 9312, control n = 8262). The median follow-up was 24.5 (Q1 = 15.25, Q3 = 28) months. Four studies recruited participants with renal impairment; baseline eGFR ranged from 23.8 to 50.5 mL/min/1.73m2. The change in eGFR for studies (n = 6) with a follow-up of 52 weeks or longer was −1.23 (−1.45, −1.01) mL/min/1.73m2. Sotagliflozin did not significantly alter urinary albumin excretion. No change was observed in the risk of CRE (n = 6 studies; RR = 0.82 [0.61, 1.12]), including in participants with renal impairment. High risk of bias was a limitation of this review.

Conclusions
Sotagliflozin did not adversely affect renal function or change the risk of key renal outcomes, including for participants with pre-existing renal impairment. Therefore, sotagliflozin was safe; however, further research is needed to determine its efficacy in reducing the risk of diabetic kidney disease.

Original language	English
Pages (from-to)	710-720
Number of pages	11
Journal	Diabetes, Obesity & Metabolism
Volume	26
Issue number	2
Early online date	29 Nov 2023
DOIs	https://doi.org/10.1111/dom.15364
Publication status	Published - Feb 2024

Bibliographical note

Open Access via the Wiley agreement

We acknowledge the contribution of Giulia Terzoli in the conceptualization of the study and of Melanie Bickerton in developing and verifying the search strategy used for this review.

Data Availability Statement

Availability of data, code and other materials: Available upon reasonable request via contacting corresponding author.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Access to Document

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Bantounou_etal_DOM_Effect_of_the_Dual_VOR
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Cite this

Bantounou, M. A., Sardellis, P., Thuemmler, R. J., Boada, D. B., Kaczmarek, J., Mahmood, R., Plascevic, J., & Phillips, S. (2024). Effect of dual SGLT1/ SGLT2 inhibitor sotagliflozin on renal outcomes in type 1 and type 2 diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials. Diabetes, Obesity & Metabolism, 26(2), 710-720. https://doi.org/10.1111/dom.15364

Effect of dual SGLT1/ SGLT2 inhibitor sotagliflozin on renal outcomes in type 1 and type 2 diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials. / Bantounou, Maria A. (Corresponding Author); Sardellis, Panagiotis; Thuemmler, Rosa J. et al.
In: Diabetes, Obesity & Metabolism, Vol. 26, No. 2, 02.2024, p. 710-720.

Research output: Contribution to journal › Article › peer-review

Bantounou, MA, Sardellis, P, Thuemmler, RJ, Boada, DB, Kaczmarek, J, Mahmood, R, Plascevic, J & Phillips, S 2024, 'Effect of dual SGLT1/ SGLT2 inhibitor sotagliflozin on renal outcomes in type 1 and type 2 diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials', Diabetes, Obesity & Metabolism, vol. 26, no. 2, pp. 710-720. https://doi.org/10.1111/dom.15364

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abstract = "Aim To investigate the renal safety profile of sotagliflozin, a novel sodium-glucose co-transporter-1 and -2 inhibitor, in patients with type 1 diabetes and type 2 diabetes, with or without renal impairment, as well as its efficacy in decreasing the risk of further renal events, with an emphasis on those with previous renal impairment. Methods Embase, Medline, CENTRAL and Scopus were searched from their inception until 24 April 2023 for randomized controlled trials that reported estimated glomerular filtration rate (eGFR), urinary albumin excretion or composite renal events (CRE). The Cochrane risk of bias 2 tool was used. Mean difference, relative risk (RR) and 95\% confidence intervals were estimated (PROSPERO: CRD42023425583). Results Fourteen studies were included in this review (n = 17 574 participants; intervention n = 9312, control n = 8262). The median follow-up was 24.5 (Q1 = 15.25, Q3 = 28) months. Four studies recruited participants with renal impairment; baseline eGFR ranged from 23.8 to 50.5 mL/min/1.73m2. The change in eGFR for studies (n = 6) with a follow-up of 52 weeks or longer was −1.23 (−1.45, −1.01) mL/min/1.73m2. Sotagliflozin did not significantly alter urinary albumin excretion. No change was observed in the risk of CRE (n = 6 studies; RR = 0.82 [0.61, 1.12]), including in participants with renal impairment. High risk of bias was a limitation of this review. Conclusions Sotagliflozin did not adversely affect renal function or change the risk of key renal outcomes, including for participants with pre-existing renal impairment. Therefore, sotagliflozin was safe; however, further research is needed to determine its efficacy in reducing the risk of diabetic kidney disease.",

author = "Bantounou, \{Maria A.\} and Panagiotis Sardellis and Thuemmler, \{Rosa J.\} and Boada, \{Daniel Black\} and Justyna Kaczmarek and Ribeya Mahmood and Josip Plascevic and Sam Phillips",

note = "Open Access via the Wiley agreement We acknowledge the contribution of Giulia Terzoli in the conceptualization of the study and of Melanie Bickerton in developing and verifying the search strategy used for this review. ",

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AU - Bantounou, Maria A.

AU - Sardellis, Panagiotis

AU - Thuemmler, Rosa J.

AU - Boada, Daniel Black

AU - Kaczmarek, Justyna

AU - Mahmood, Ribeya

AU - Plascevic, Josip

AU - Phillips, Sam

N1 - Open Access via the Wiley agreement We acknowledge the contribution of Giulia Terzoli in the conceptualization of the study and of Melanie Bickerton in developing and verifying the search strategy used for this review.

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N2 - Aim To investigate the renal safety profile of sotagliflozin, a novel sodium-glucose co-transporter-1 and -2 inhibitor, in patients with type 1 diabetes and type 2 diabetes, with or without renal impairment, as well as its efficacy in decreasing the risk of further renal events, with an emphasis on those with previous renal impairment. Methods Embase, Medline, CENTRAL and Scopus were searched from their inception until 24 April 2023 for randomized controlled trials that reported estimated glomerular filtration rate (eGFR), urinary albumin excretion or composite renal events (CRE). The Cochrane risk of bias 2 tool was used. Mean difference, relative risk (RR) and 95% confidence intervals were estimated (PROSPERO: CRD42023425583). Results Fourteen studies were included in this review (n = 17 574 participants; intervention n = 9312, control n = 8262). The median follow-up was 24.5 (Q1 = 15.25, Q3 = 28) months. Four studies recruited participants with renal impairment; baseline eGFR ranged from 23.8 to 50.5 mL/min/1.73m2. The change in eGFR for studies (n = 6) with a follow-up of 52 weeks or longer was −1.23 (−1.45, −1.01) mL/min/1.73m2. Sotagliflozin did not significantly alter urinary albumin excretion. No change was observed in the risk of CRE (n = 6 studies; RR = 0.82 [0.61, 1.12]), including in participants with renal impairment. High risk of bias was a limitation of this review. Conclusions Sotagliflozin did not adversely affect renal function or change the risk of key renal outcomes, including for participants with pre-existing renal impairment. Therefore, sotagliflozin was safe; however, further research is needed to determine its efficacy in reducing the risk of diabetic kidney disease.

AB - Aim To investigate the renal safety profile of sotagliflozin, a novel sodium-glucose co-transporter-1 and -2 inhibitor, in patients with type 1 diabetes and type 2 diabetes, with or without renal impairment, as well as its efficacy in decreasing the risk of further renal events, with an emphasis on those with previous renal impairment. Methods Embase, Medline, CENTRAL and Scopus were searched from their inception until 24 April 2023 for randomized controlled trials that reported estimated glomerular filtration rate (eGFR), urinary albumin excretion or composite renal events (CRE). The Cochrane risk of bias 2 tool was used. Mean difference, relative risk (RR) and 95% confidence intervals were estimated (PROSPERO: CRD42023425583). Results Fourteen studies were included in this review (n = 17 574 participants; intervention n = 9312, control n = 8262). The median follow-up was 24.5 (Q1 = 15.25, Q3 = 28) months. Four studies recruited participants with renal impairment; baseline eGFR ranged from 23.8 to 50.5 mL/min/1.73m2. The change in eGFR for studies (n = 6) with a follow-up of 52 weeks or longer was −1.23 (−1.45, −1.01) mL/min/1.73m2. Sotagliflozin did not significantly alter urinary albumin excretion. No change was observed in the risk of CRE (n = 6 studies; RR = 0.82 [0.61, 1.12]), including in participants with renal impairment. High risk of bias was a limitation of this review. Conclusions Sotagliflozin did not adversely affect renal function or change the risk of key renal outcomes, including for participants with pre-existing renal impairment. Therefore, sotagliflozin was safe; however, further research is needed to determine its efficacy in reducing the risk of diabetic kidney disease.

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