Study objective

The efficacy and safety of sotagliflozin, a sodium-glucose cotransporter 2 inhibitor, in preventing cardiovascular events in diabetes patients with chronic kidney disease with or without albuminuria are not well studied. Hence, this study aimed to evaluate the role of sotagliflozin in preventing cardiovascular risks.

Methods

A multicentre, double-blind trial in which patients with type 2 diabetes mellitus (HbA1c≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 mL per minute per 1.73m² of body surface area), and risks for cardiovascular disease were randomly assigned in a 1:1 ratio to receive sotagliflozin) or placebo. The primary endpoint was changed during the trial to the composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure.

Results

Out of the 19 188 patients screened, 10 584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the placebo group and followed for a median of 16 months. The rate of primary endpoint events was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.63 to 0.88; P<0.001). The rate of primary endpoint events was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.63 to 0.88; P<0.001).

The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P=0.35).

Conclusions

In patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin resulted in a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure than placebo but was linked with adverse events.

Reference

Bhatt Dl, Szarek M, Pitt B, Cannon CP, et al. Sotagliflozin in patients with diabetes and chronic kidney disease. The New England Journal of Medicine. November 16, 2020. DOI: 10.1056/NEJMoa2030186