Sotagliflozin CV Signal
A clinical overview highlights sotagliflozin (Inpefa), an oral dual SGLT1/2 inhibitor, showing efficacy in reducing the risk of death from heart failure — an important cardiometabolic advance for T2D patients with high CV risk. The profile positions sotagliflozin as another oral option marrying glycemic and heart‑failure benefits Clinical Overview: Sotagliflozin (Inpefa) for Heart Failure | Pharmacy Times.
The FDA approved Inpefa (sotagliflozin) on May 26, 2023 for reducing cardiovascular death, hospitalization for heart failure, and urgent heart‑failure visits in adults with heart failure or with type 2 diabetes plus chronic kidney disease and other cardiovascular risk factors. (accessdata.fda.gov) SOLOIST‑WHF (n=1,222) reported a 33% relative reduction in its primary composite endpoint with a hazard ratio of 0.67 (95% CI 0.52–0.85) and event rates of 70 vs. 98 events per 100 patient‑years, with statistical separation by 28 days. (acc.org) The SCORED trial in patients with type 2 diabetes and chronic kidney disease showed a roughly 26% reduction in the same composite of total CV deaths, HF hospitalizations, and urgent HF visits, and pooled analyses of SCORED+SOLOIST (~11,800 patients) preserved benefit across ejection‑fraction subgroups including HFpEF. (heart.org) A post‑hoc analysis of SOLOIST‑WHF found starting sotagliflozin on or before hospital discharge cut the relative risk of cardiovascular death or HF rehospitalization by about 51% at 30 days and by roughly 46% at 90 days versus placebo. (patientcareonline.com) Regulatory review and meta‑analyses flagged safety signals: diabetic ketoacidosis risk was elevated (pooled RR ≈3.93), and sotagliflozin increased genital mycotic infections, diarrhea, and volume‑depletion events; the FDA review lists DKA, volume depletion, urosepsis and pyelonephritis among serious reactions. (bmj.com) Lexicon’s materials and trial data report a low number‑needed‑to‑treat (NNT ≈4 patient‑years) to prevent one primary composite event, and the dosing regimen used in trials began at 200 mg once daily with uptitration to 400 mg when tolerated. (inpefahcp.com)
