Sodium-glucose cotransporter 2 (SGLT2) inhibitors are given as the first-line treatment for type-2 diabetes and the prevention of cardiovascular events. However, the efficacy of SGLT2 inhibitors like sotagliflozin in the prevention of cardiovascular events in patients with type 2 diabetes and chronic kidney disease (CKD) is not known. This study aims to evaluate the same.
This multicenter, double-blind trial included a total of 10,584 patients with type 2 diabetes, CKD, and the risk for cardiovascular disease. The patients were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. The primary outcome of the study was the composite of the total number of deaths from cardiovascular causes or heart failure.
The rate of primary endpoint event was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group. The rate of death from cardiovascular events was 2.2 per 100 patient-years for sotagliflozin and 2.4 per 100 patient-years for placebo. Common adverse events occurring in both groups were diarrhea, volume depletion, general myotic infections, and diabetic ketoacidosis.
The research concluded that the sotagliflozin resulted in a lower risk of death of cardiovascular events in patients with diabetes and CKD.
Ref: https://www.nejm.org/doi/full/10.1056/NEJMoa2030186
