Cardiorenal Safety and Efficacy of Sotagliflozin: A Stratified Meta-Analysis by Diabetes Type and Dosage.

AIMS: Sotagliflozin is a novel dual sodium-glucose cotransporter inhibitor (SGLTi). At present, the comprehensive assessment of its influence on cardiorenal outcomes in diabetic patients remains inadequate.

MATERIALS AND

METHODS

We retrieved and screened RCTs of sotagliflozin for diabetes from online databases. Primary endpoint was the expanded major adverse cardiovascular and heart failure composite endpoint, comprising cardiovascular death, heart failure hospitalisation, non-fatal myocardial infarction, and non-fatal stroke; secondary endpoint was substantial renal function decline. Pooled effect sizes were calculated as relative risk (RR) and 95% confidence interval (CI). Cochrane RoB 2.0 assessed bias risk. Subgroup, sensitivity, cumulative analyses, and publication bias tests verified result robustness.

RESULTS

After strict screening, 11 high-quality RCT datasets (including 7 peer-reviewed full publications and 4 ClinicalTrials.gov registry records) were ultimately included. Meta-synthesis results demonstrated that sotagliflozin was associated with a reduced risk of the expanded cardiovascular composite endpoint (RR = 0.80, 95% CI [0.75, 0.88], p < 0.01). Regarding the incidence of a substantial decline in renal function, the sotagliflozin group showed a potential protective tendency, but it was not statistically significant (RR = 0.77, 95% CI [0.46, 1.27], p = 0.53). Subgroup analyses revealed that sotagliflozin maintained a highly consistent cardiovascular benefit in patients with type 2 diabetes mellitus, in studies adopting flexible dose titration (200 → 400 mg), and across different follow-up periods. Sensitivity and cumulative analyses confirmed the high robustness of the core findings.

CONCLUSIONS

Sotagliflozin provides significant and consistent cardiovascular benefit in patients with diabetes, particularly type 2 diabetes, with good safety. A potential renal protective trend exists. It is an effective treatment for diabetic patients at high cardiovascular risk.