Bhatt D.L. et al. studied the efficacy and safety of sotagliflozin, a sodium–glucose cotransporter 2 inhibitor, in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria.

They conducted a multicenter, double-blind trial including patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml/minute/1.73 m2 of body-surface area), and risks for cardiovascular disease.

The patients were randomized to receive either sotagliflozin or placebo. 

The primary end-point was the assessment of- a composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure.

The observations of the study were-

The rate of primary end-point events-

• 5.6 events per 100 patient-years in the sotagliflozin group
• 7.5 events per 100 patient-years in the placebo group 

The rate of deaths from cardiovascular causes-

• 2.2 per 100 patient-years in sotagliflozin
• 2.4 per 100 patient-years in the placebo
• Adverse events like Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis occurred more commonly with sotagliflozin than with placebo.

Thus the researchers concluded that in patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin shows a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure than placebo but is associated with more adverse events. 

Source-Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK. et al. Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome, N Engl J Med, 2021;384(9):818-828. doi: 10.1056/NEJMoa2008290.