Sotagliflozin in patients with diabetes and CKD

In the SCORED clinical trial, researchers evaluated sotagliflozin as prophylaxis against cardiovascular (CV) events in patients with diabetes and chronic kidney disease (CKD). The sample population included 10,584 participants matching this patient profile.

In the SCORED clinical trial, researchers evaluated sotagliflozin as prophylaxis against cardiovascular (CV) events in patients with diabetes and chronic kidney disease (CKD). The sample population included 10,584 participants matching this patient profile. One-half were randomized to treatment with sotagliflozin, a sodium-glucose cotransporter 2 inhibitor, with the other one-half assigned to the placebo group. At a median followup of 16 months, investigators measured the revised primary outcome of composite of total number of deaths from CV causes, hospitalizations for heart failure, and urgent visits for heart failure. The rate of primary endpoint events was 5.6 per 100 patient-years in the intervention group and 7.5 events per 100 patient-years in the control group. The rate of CV-related deaths was 2.2 and 2.4 per 100 patient-years, respectively. Although loss of funding resulted in the trial terminating early, preliminary results showed that sotagliflozin offers cardio-protective effects in patients with diabetes and CKD. However, the researchers noted, the study drug was associated with a higher rate of adverse events, including diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis.