Deepak L Bhatt 1, Michael Szarek 1, Bertram Pitt 1, Christopher P Cannon 1, Lawrence A Leiter 1, Darren K McGuire 1, Julia B Lewis 1, Matthew C Riddle 1, Silvio E Inzucchi 1, Mikhail N Kosiborod 1, David Z I Cherney 1, Jamie P Dwyer 1, Benjamin M Scirica 1, Clifford J Bailey 1, Rafael Díaz 1, Kausik K Ray 1, Jacob A Udell 1, Renato D Lopes 1, Pablo Lapuerta 1, P Gabriel Steg 1, SCORED Investigators
Main idea: 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 associated with adverse events.
Background: The efficacy and safety of sodium-glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied.
Methods: We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus were randomly assigned to receive sotagliflozin or a placebo. The primary end point was changed during the trial to the composite of the total number of deaths from cardiovascular causes. The trial ended early owing to loss of funding. Results: Of 19,188 patients screened, 10,584 were enrolled. 5292 were assigned to the sotagliflozin group and 5292 to the placebo group. The rate of primary end-point events was 5.6 events per 100 patient-years in the sotsotag liflozin groups. Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis were more common with sotagslobin than with placebo.