Lexicon Pharmaceuticals has announced that a post-hoc analysis (“Efficacy of Sotagliflozin Among Older Adults: A Pooled Analysis of SCORED and SOLOIST-WHF”) of clinical data was presented in August during an oral presentation at the European Society of Cardiology (ESC) 2025 Congress in Madrid, Spain.
It is well-established that the incidence of stroke and myocardial infarction (MI, or heart attack), known collectively as major cardiovascular adverse events (MACE), rises with age, as does incidence of heart failure (HF) events. Sotagliflozin, a dual sodium-glucose cotransport 1 and 2 (SGLT-1 and SGLT-2) inhibitor, was approved by the FDA based on its demonstrated efficacy in improving HF endpoints in patients with chronic kidney disease (CKD) or HF. This latest Lexicon-funded analysis examined how the efficacy of sotagliflozin varies with age, particularly among older adults, and used data pooled from the two previous pivotal Phase 3 studies of sotagliflozin, SCORED and SOLOIST-WHF. The robust data set included nearly 12,000 participants, about 70% of whom were 65 or older. This age group represents a very large population in which type 2 diabetes, CKD and/or worsening HF are relatively common. Patients were evaluated by age, both categorically (≥65 years vs <65 years) and continuously. The primary endpoint was total cardiovascular (CV) death, hospitalization for HF, or urgent visit for HF. Additional endpoints included total MACE. Sotagliflozin demonstrated a consistent reduction in both endpoints, as compared to placebo across the spectrum of age.
Study results
The pooled analysis of SCORED and SOLOIST-WHF included a total of 5,900 (50.0%) and 5,906 (50.0%) patients were in the sotagliflozin and placebo groups, respectively. The median age of such patients was 69 years (interquartile range: 63, 74 years), with 3,588 (30.4%) and 8,218 (69.6%) patients <65 vs ≥65 years old, respectively.
Compared to placebo, sotagliflozin reduced the rate of the primary endpoint (total CV death and hospitalization or urgent visit for HF) overall (8.5 vs 11.8 events/100 person-years [p-y]; hazard ratio [HR]: 0.72), among adults <65 years (7.6 vs 10.2 events/100 p-y; HR: 0.68), and ≥65 years (8.9 vs 12.4 events/100 p-y; HR: 0.73).
Sotagliflozin similarly reduced total MACE compared with placebo (5.7 vs 7.1 events/100 p-y; HR: 0.80), with consistent findings among adults <65 years (5.1 vs 6.2 events/100 p-y; HR: 0.79) and ≥65 years (5.9 events/100 p-y vs 7.4 events/100 p-y; HR: 0.80).
