Lexicon Pharmaceuticals, Inc. announced a new post-hoc analysis of clinical data showing that INPEFA® (sotagliflozin), a dual oral inhibitor of SGLT2 and SGLT1, reduced the risk of heart failure-related events across a diverse population of patients, including patients with preserved ejection fraction (HFpEF). Researchers noted that INPEFA appeared to be particularly effective in reducing the risk of heart failure events in patients with an obesity-related HFpEF phenotype. These findings, based on a pooled, patient-level analysis of data from the SOLOST-WHF and SCORED pivotal clinical trials, were presented at the Annual Congress of the Heart Failure Association of the European Society of Cardiology (ESC) in Lisbon, Portugal.

Obesity and type 2 diabetes (T2D), along with a growing aging population, is contributing to the escalating prevalence of HFpEF. Recent data published in journals of the American College of Cardiology and the American Heart Association suggest that individuals with an obesity-related HFpEF phenotype represent a distinctive and clinically significant subgroup from those with standard HFpEF phenotype. This new analysis assessed the impact of obesity, along with sex and age, on the effects of INPEFA on the primary composite endpoint of cardiovascular (CV) death and heart failure (HF) events in patients with left ventricular ejection fraction (LVEF) = 50%.

Previously, SOLOIST-WHF and SCORED data demonstrated that INPEFA, a dual oral inhibitor of SGLT2 and SGLT1, is effective in reducing the risk of CV death and HF-related outcomes across the LVEF range. Data from a total of 1,932 patients were included in the analysis (mean age: 69.9 years, mean BMI: 34.1 kg/m²; mean HbA1c: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: 10.9% vs. = 65years: 20.3%) and higher BMI (< 30 kg/m²: 16.6% vs. = 30 kg/m²: 18.7%) were associated with an increased number of patients at risk for primary endpoint events.

Within the subgroup characterized by higher BMI, INPEFA therapy resulted in a favorable response for patients with BMI = 30 kg/m² (p-value for interaction 0.038). Researchers also noted that both sex and age subgroups had a consistent response to INPEFA (p-value for interaction 0.818 and 0.393, respectively). Discovered using Lexicon?s unique approach to gene science, INPEFA® (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1).

SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.