March 4, 2023 - Lexicon Pharmaceuticals, Inc. announced new analyses of results from the SOLOIST-WHF Phase 3 outcomes study of its investigational product sotagliflozin presented at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology in New Orleans, Louisiana.
The “Time to Clinical Benefit of Sotagliflozin in People with Worsening Heart Failure in SOLOIST-WHF” post hoc analysis examined the timing of clinical benefit of sotagliflozin, defined as the first day post randomization when the hazard ratio (HR) for risk for the primary outcome of total number of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure was statistically significant (p<0.05) and remained significant throughout follow up. A subgroup analysis was also conducted in patients with left ventricular ejection fraction (LVEF) < 50% or ≥ 50%.
The analysis showed a statistically significant reduction in the risk for the primary outcome on Day 27, or time to clinical benefit of 27 days, in patients with worsening heart failure (WHF) treated with sotagliflozin. Furthermore, these findings were generally consistent across the LVEF range.
“Patients with heart failure admitted with worsening disease are at substantial risk for rehospitalization and death in the short-term,” stated Dr. Deepak L. Bhatt, Director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at Icahn School of Medicine at Mount Sinai. “In SOLOIST-WHF, early initiation of sotagliflozin reduced the risk of cardiovascular events in the short-term and also in the long-term.”
As previously reported, in patients admitted with WHF, sotagliflozin significantly reduced the composite of total cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (UVHF) by 33%.
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April 02, 2026 
