According to the result of the trial was published in The NEW ENGLAND JOURNAL of MEDICINE on November 16, 2020 Sotagliflozin lowers total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo. SOLOIST-WHF trial is the first large randomized controlled trial to show that SGLT2 inhibitor is safe and effective for type 2 diabetic patients with acute cardiac failure.Unlike other Sodium Glucose co transport inhibitors, Sotagliflozin is a dual inhibitor of selective sodium-glucose transporters 1 and 2 (SGLT-1, SGLT-2).
Dr.Deepak L. Bhatt et al, performed a clinical trial on Sotagliflozin to compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable patients after admission for worsening heart failure (WHF).
It was a randomized controlled, multicentric, double blinded trial on patients with type 2 Diabetes Mellitus who were hospitalized for cardiac failure. A total of 1222 patients were randomly assigned to either Sotagliflozin (n= 608) or Placebo (n=614) treatment arm and were followed for median of 9 months. The drug was initiated either prior to or within 3 days of discharge. The primary endpoint of the study was total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events).
Among the 2 treatment groups, 600 reached the primary endpoint, for sotagliflozin vs. Placebo it was 70 vs. 98 events/100 patient-years.The rate of death from cardiovascular causes was 10.6 events/100 patient-years in the sotagliflozin group and 12.5 events/100 patient-years in the placebo group. Though the study ended early, it showed sotagliflozin has a significant effect in cardiovascular outcomes than placebo. The benefits were consistent in those with Cardiac failure with reduced but also preserved EF ( Ejection Fraction).
Author concluded stating "In patients with diabetes and recent worsening heart failure, sotagliflozin therapy, initiated before or shortly after discharge, resulted in a significantly lower total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo"
For further information:
https://www.nejm.org/doi/full/10.1056/NEJMoa2030183
Trial registry number : NCT03521934
DOI: 10.1056/NEJMoa2030183