A post-hoc analysis of the SCORED clinical trial identified early benefit for patients taking Inpefa in both heart failure and major adverse cardiovascular events (MACE) related outcomes
The time to clinical benefit with Inpefa (sotagliflozin) was about three months, which was identified through a post hoc analysis of the SCORED clinical trial. This analysis was presented at the American Heart Association Scientific Sessions meeting in Philadelphia by Rahul Aggarwal, M.D., a cardiology fellow at Brigham and Women’s Hospital in Boston.
Developed by Lexicon Pharmaceuticals, Inpefa was approved in May 2023 to treat patients with heart failure. Inpefa is an inhibitor of SGLT2 and SGLT1 and is a once-daily oral tablet that reduces the risk of cardiovascular death and hospitalization for heart failure in adults.
Heart failure is the leading cause of hospitalizations for individuals aged 65 and older, triggering about 1.3 million hospitalizations a year.
This analysis looked at data from the SCORED phase 3 trial, which was a study of 10,584 patients with type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. Patients were randomized 1:1 to Inpefa or placebo. Patients with diabetes are at risk for heart failure, according to the CDC. High blood sugar can damage blood vessels and the nerves that control the heart.
The primary endpoint in SCORED was total cardiovascular death, hospitalization for hearth failure, or urgent visit for heart failure. A prespecified secondary endpoint was total major adverse cardiovascular events (MACE) outcomes. Inpefa resulted in a 25% risk reduction in the composite endpoint of cardiovascular death, hospitalization and urgent heart failure visit, as well as a 21% risk reduction in 3-point MACE. The most frequent treatment-related adverse reactions were urinary tract infection, diarrhea, hypoglycemia, dizziness, genital mycotic infection, and diabetic ketoacidosis. Data from SCORED were published in the New England Journal of Medicine in 2021.
In the post hoc analysis discussed at the AHA meeting, researchers calculated the Inpefa-to-placebo hazard ratios (HR) and 95% confidence intervals (CI) for each of the outcomes in the SCORED trial. The analysis determined that the day after randomization where the treatment effect reached statistical significance. It remained statistically significant for the duration of follow-up.
“Avoiding a stroke or myocardial infarction can have great benefit to both patients and the healthcare system, and we believe that the observed reductions in MACE as early as approximately three months are additional points of differentiation for Inpefa,” Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, said in a press release.
Sotaglifozin is also being studied in type 1 diabetes.