The USFDA has approved sotagliflozin , an inhibitor of sodium-glucose cotransporters 1 and 2 , for reducing the risk of hospitalization for heart failure (HF), cardiovascular (CV) death, and urgent HF visits in adults with HF or type 2 diabetes mellitus (T2DM), chronic kidney disease (CKD), and other CV risk factors. However, the mechanism of sotagliflozin in providing cardiovascular benefits has not been established yet. Nevertheless, this approval was granted based on the findings of two clinical trials.
Clinical trials The safety and efficacy of sotagliflozin were evaluated on 11,806 T2DM patients hospitalized for worsening HF (Median age – 70 years) or patients with T2DM, CKD, and additional CV risk factors (Median age – 68 years). Compared to placebo, sotagliflozin was superior in achieving the reduction of the overall occurrence of CV death, hospitalization for HF, and urgent HF…
