Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure

This multicenter, double blind trial evaluated the safety and efficacy of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in patients with type 2 diabetes recently hospitalized for worsening heart failure. A total of 1,222 patients were randomized to receive sotagliflozin or placebo, with the first dose administered before or shortly after discharge. The primary endpoint was the total number of cardiovascular deaths, hospitalizations, and urgent visits for heart failure. Over a median follow up of 9 months, the rate of primary endpoint events was significantly lower in the sotagliflozin group (51.0 per 100 patient-years) compared to placebo (76.3 per 100 patient-years; hazard ratio, 0.67; 95% CI, 0.52–0.85; P < 0.001). Sotagliflozin also reduced heart failure related hospitalizations and urgent visits but did not significantly affect cardiovascular or all-cause mortality. Adverse events included diarrhea (6.1% vs. 3.4%) and severe hypoglycemia (1.5% vs. 0.3%). The study concluded that sotagliflozin, initiated early after hospitalization, significantly improved outcomes in this high-risk population.

This multicenter, double blind trial evaluated the safety and efficacy of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in patients with type 2 diabetes recently hospitalized for worsening heart failure. A total of 1,222 patients were randomized to receive sotagliflozin or placebo, with the first dose administered before or shortly after discharge. The primary endpoint was the total number of cardiovascular deaths, hospitalizations, and urgent visits for heart failure. Over a median follow up of 9 months, the rate of primary endpoint events was significantly lower in the sotagliflozin group (51.0 per 100 patient-years) compared to placebo (76.3 per 100 patient-years; hazard ratio, 0.67; 95% CI, 0.52–0.85; P < 0.001). Sotagliflozin also reduced heart failure related hospitalizations and urgent visits but did not significantly affect cardiovascular or all-cause mortality. Adverse events included diarrhea (6.1% vs. 3.4%) and severe hypoglycemia (1.5% vs. 0.3%). The study concluded that sotagliflozin, initiated early after hospitalization, significantly improved outcomes in this high-risk population.