Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure

This phase 3 randomized trial (SOLOIST-WHF) evaluated sotagliflozin, a dual SGLT1/SGLT2 inhibitor in patients with type 2 diabetes recently hospitalized for worsening heart failure. A total of 1222 participants were randomized to sotagliflozin or placebo before or shortly after discharge, with a median follow-up of 9 months. Sotagliflozin significantly reduced the total number of cardiovascular deaths, hospitalizations, and urgent visits for heart failure (51.0 vs. 76.3 events per 100 patient-years; HR: 0.67; 95% CI: 0.52–0.85; P<0.001). Benefits were consistent regardless of ejection fraction, renal function, or timing of initiation. Adverse events more common with sotagliflozin included diarrhea (6.1% vs. 3.4%) and severe hypoglycemia (1.5% vs. 0.3%), but rates of hypotension and acute kidney injury were similar. While the trial was stopped early due to funding loss and relied on investigator-reported endpoints, the data support sotagliflozin’s early use in high-risk heart failure patients with diabetes to reduce recurrent events.

This phase 3 randomized trial (SOLOIST-WHF) evaluated sotagliflozin, a dual SGLT1/SGLT2 inhibitor in patients with type 2 diabetes recently hospitalized for worsening heart failure. A total of 1222 participants were randomized to sotagliflozin or placebo before or shortly after discharge, with a median follow-up of 9 months. Sotagliflozin significantly reduced the total number of cardiovascular deaths, hospitalizations, and urgent visits for heart failure (51.0 vs. 76.3 events per 100 patient-years; HR: 0.67; 95% CI: 0.52–0.85; P<0.001). Benefits were consistent regardless of ejection fraction, renal function, or timing of initiation. Adverse events more common with sotagliflozin included diarrhea (6.1% vs. 3.4%) and severe hypoglycemia (1.5% vs. 0.3%), but rates of hypotension and acute kidney injury were similar. While the trial was stopped early due to funding loss and relied on investigator-reported endpoints, the data support sotagliflozin’s early use in high-risk heart failure patients with diabetes to reduce recurrent events.