- Question
- Is it safe and effective to start sotagliflozin in patients with type 2 diabetes who have just had an episode of decompensated heart failure, either before or shortly after discharge?
- Design
- Multicenter, randomized, double-blind, placebo-controlled trial with 1222 patients (608 on sotagliflozin and 614 on placebo) and a median follow-up of 9.0 months. The trial ended early because the sponsor withdrew funding.
- Population
- Patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure and were hemodynamically stable.
- Intervention
- Sotagliflozin 200 mg once daily, with possible up-titration to 400 mg during the first 8 months. The first dose was given before discharge in 48.8% and a median of 2 days after discharge in 51.2%.
- Control
- Matching placebo, with the same possibility of up-titration.
- Primary outcome
- Total number of cardiovascular deaths, hospitalizations and urgent visits for heart failure (first and subsequent events).
- Results
- There were 600 primary end-point events (245 with sotagliflozin and 355 with placebo); the rate was 51.0 vs. 76.3 per 100 patient-years (HR 0.67; 95% CI 0.52 to 0.85; P<0.001). Cardiovascular death had an HR of 0.84 (95% CI 0.58 to 1.22).
- Safety
- Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%). Hypotension (6.0% vs. 4.6%) and acute kidney injury (4.1% vs. 4.4%) were similar between groups.
- Conclusion
- In patients with diabetes and recent worsening heart failure, starting sotagliflozin before or shortly after discharge lowered the total number of cardiovascular deaths and heart failure hospitalizations or urgent visits compared with placebo.
- Why it matters
- It showed that an SGLT2 inhibitor can be started safely in the immediate period after decompensation, a time of high risk, and supported early use of this drug class in patients with heart failure and diabetes.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026