Lexicon Pharmaceuticals, Inc. announced findings from a new post hoc analysis of clinical data, which demonstrated that sotagliflozin, a dual oral inhibitor of sodium-glucose transport (SGLT) 1 and SGLT2, decreased the risk of heart failure (HF)–related events across a diverse population of patients, including patients with HF with preserved ejection fraction (HFpEF).

The researchers indicated that sotagliflozin appeared to be particularly effective in reducing the risk of HF events in patients with an obesity-related HFpEF phenotype. Based on a pooled, patient-level analysis of data from the SOLOST-WHF and SCORED pivotal clinical trials, these findings were recently presented at the Annual Congress of the Heart Failure Association of the European Society of Cardiology (ESC) in Lisbon, Portugal.

The researchers indicated that findings from this new analysis add to the body of evidence distinguishing sotagliflozin as a dual oral inhibitor of SGLT1 and SGLT2.

Recent data published in the American College of Cardiology and the American Heart Association journals suggested that individuals with an obesity-related HFpEF phenotype represent a distinctive and clinically significant subgroup from those with standard HFpEF phenotype. Previously, data from SOLOIST-WHF and SCORED trials demonstrated that sotagliflozin effectively reduces the risk of cardiovascular (CV) death and HF-related outcomes across the left ventricular ejection fraction (LVEF) range.

In the new analysis, researchers evaluated the impact of obesity, along with gender and age, on the effects of sotagliflozin on the primary composite endpoint of CV death and HF events in patients with LVEF ≥50%.

Data from 1,932 patients were included in the analysis (mean age: 69.9 years, mean BMI: 34.1 kg/m2; average glycosylated hemoglobin A1C: 8.5%). In this population, 18.1% of patients experienced a primary endpoint event. Males and females demonstrated comparable event rates, 18.3% and 18.0%, respectively; however, older age (<65 years: 10.9% vs. ≥65 years: 20.3%) and higher BMI (<30 kg/m2: 16.6% vs. ≥30 kg/m2: 18.7%) were correlated with an increased number of patients at risk for primary endpoint events.

Within the subgroup characterized by higher BMI, sotagliflozin therapy resulted in a favorable response for patients with BMI ≥30 kg/m2 (P-value for interaction 0.038). The researchers also noted that both gender and age subgroups consistently responded to sotagliflozin (P-value for interaction 0.818 and 0.393, respectively).

Craig Granowitz, MD, PhD, Lexicon’s senior VP and CMO, stated, “This analysis underscores the importance of identifying patient risk factors such as age, sex, and obesity in patients with HFpEF and adds to the body of evidence differentiating INPEFA as a dual inhibitor of SGLT1 and SGLT2. Additionally, today’s data presentation further highlights the benefits of INPEFA in reducing the risk of heart failure-related events across a wide range of patients with HFpEF, including in patients with an obesity-related HFpEF phenotype.”

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