On May 26, the US Food and Drug Administration (FDA) approved Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter (SGLT) 1 and 2, for lowering the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits, as well as preventing these events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.

The approval was based on the trail named “ Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure (SOLOIST-WHF),” which studied the effect of the SGLT1 and 2 inhibitor Sotagliflozin on 30- and 90-day CV mortality and HF readmission rates after discharge.

Among 1222 randomized T2D patients, 86% were hospitalized for their index WHF incident and 46% began study medication before or at discharge. The Cochran-Mantel-Haenszel test was used to compare region and baseline LVEF. 

Sotagliflozin treatment resulted in a substantial relative risk reduction of >50% for readmission for non-fatal HF-related events or the composite of CV mortality and readmission for HF-related events within 30 or 90 days after discharge compared to placebo. 

The Sotagliflozin safety profile was consistent throughout the study period, and hence the drug appeared safe.(Source:

1.    https://www.medscape.com/viewarticle/992518?src=#vp_12.    https://www.ahajournals.org/doi/10.1161/circ.146.suppl_1.10209)