Cost-Effectiveness of INPEFA® (Sotagliflozin) Published in JACC: Heart Failure

A recent study from Lexicon Pharmaceuticals, published in the Journal of the American College of Cardiology: Heart Failure, has concluded that INPEFA® (sotagliflozin) is cost-effective for individuals with diabetes and recent worsening heart failure. The study aligns with research published in the Journal of Comparative Effectiveness Research, reaffirming INPEFA's financial and clinical value.

The study, led by Dr. William S. Weintraub from MedStar Health Research Institute, assessed the cost-effectiveness of sotagliflozin, an SGLT inhibitor, from the U.S. healthcare system's perspective. Utilizing Consolidated Health Economic Evaluation Reporting Standards, the analysis revealed that people treated with INPEFA experienced a lifetime quality-adjusted life-year (QALY) of 4.43 compared to 4.04 in the placebo group.

In a parallel study, researchers used real-world data and the SOLOIST-WHF trial results to evaluate INPEFA's efficacy. They found that INPEFA led to a net gain of 0.425 QALYs compared to standard care, establishing the drug as a cost-effective option for patients hospitalized with heart failure and diabetes.

Craig Granowitz, Lexicon's senior vice president and chief medical officer, emphasized that these findings support the notion that INPEFA not only offers substantial clinical benefits but also significant financial value for the U.S. healthcare system.

Lexicon Pharmaceuticals is committed to pioneering medicines that transform patients' lives. Their unique genomics platform has identified over 100 protein targets with therapeutic potential across various diseases. INPEFA, an oral inhibitor of SGLT2 and SGLT1, regulates glucose by affecting both the kidney and gastrointestinal tract. It has been studied in heart failure, diabetes, and chronic kidney disease involving around 20,000 patients.

INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure, type 2 diabetes, chronic kidney disease, and cardiovascular risk factors. However, it carries several important safety warnings. Notably, it can cause ketoacidosis, especially in patients with type 1 diabetes or other risk factors, and it is not indicated for glycemic control.

Patients should be monitored for signs of metabolic acidosis or ketoacidosis, and therapy should be paused if symptoms arise. INPEFA can also result in volume depletion, leading to symptomatic hypotension or acute kidney issues, particularly in patients with preexisting renal impairment, older patients, or those on diuretics. It also increases the risk of urinary tract infections and necessitates careful monitoring for conditions like hypoglycemia when used with insulin.

Additionally, INPEFA has been linked to rare but severe conditions such as Fournier’s Gangrene and genital mycotic infections. It is not recommended for patients with moderate or severe hepatic impairment. Pregnant or breastfeeding women should avoid INPEFA, and elderly patients need close monitoring due to a higher risk of volume depletion.

Lexicon Pharmaceuticals continues to explore new therapeutic possibilities based on their extensive genomic research. Their ongoing studies aim to bring innovative treatments for a variety of conditions, focusing on safe and effective therapies.

The findings from these studies underscore INPEFA’s role in providing both clinical and economic benefits, supporting its use as a viable treatment option in managing heart failure and diabetes within the U.S. healthcare framework.