New FDA-Approved Diabetes Drug Slashes Heart Attack and Stroke Risk
Sotagliflozin significantly reduces heart attacks and strokes in high-risk patients with diabetes and kidney disease, offering a new treatment option for cardiovascular protection.
Sotagliflozin, a recently FDA-approved drug for treating type 2 diabetes and kidney disease in patients with additional cardiovascular risk factors, has been shown to significantly reduce the risk of heart attack and stroke, according to an international clinical trial led by a Mount Sinai researcher.
Sotagliflozin is a sodium-glucose cotransporter (SGLT) inhibitor that targets both SGLT1 and SGLT2 proteins. These proteins help regulate blood sugar by transporting glucose and sodium across cell membranes. Unlike other SGLT2 inhibitors, sotagliflozin more effectively blocks SGLT1, offering a unique mechanism of action.
The study, published February 14 in The Lancet Diabetes & Endocrinology, is the first to show that an SGLT inhibitor has these unique cardiovascular benefits. The results mean that sotagliflozin could become more widely used to reduce the risk of deadly cardiovascular events globally.
Evidence from the SCORED Clinical Trial
“These results demonstrate a new mechanism of action—combined blockade with sotagliflozin of the SGLT1 receptors (found in the kidney, gut, heart, and brain) and SGLT2 receptors (found in the kidney)—to reduce heart attack and stroke risk,” says study chair Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai. “The benefits seen here are distinct from those seen with the other very popular SGLT2 inhibitors in widespread clinical use for diabetes, heart failure, and kidney disease.”
The randomized, multicenter trial, known as SCORED, analyzed the ability of sotagliflozin to reduce the risks of life-threatening cardiovascular outcomes. Researchers enrolled 10,584 patients with chronic kidney disease, type 2 diabetes, and additional cardiovascular risk factors; randomly assigned them to sotagliflozin or placebo; and followed them for an average of 16 months. Patients in the sotagliflozin group had a 23 percent reduction in the rate of heart attacks, strokes, and deaths from such cardiovascular causes compared with the placebo group.
“Physicians now have a new option to reduce global cardiovascular risk such as heart failure, progression of kidney disease, heart attack, and stroke in patients with either heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors,” adds Dr. Bhatt. “This drug was approved to reduce the risk of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent heart failure visits for patients with either heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. These important, new data show that it additionally reduces the risk of heart attacks and strokes, and we could see more widespread use as a result.”
Reference: “Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial” by Rahul Aggarwal, Deepak L Bhatt, Michael Szarek, Christopher P Cannon, Lawrence A Leiter, Silvio E Inzucchi, Renato D Lopes, Darren K McGuire, Julia B Lewis, Matthew C Riddle, Michael J Davies, Phillip Banks, Amy K Carroll, Benjamin M Scirica, Kausik K Ray, Mikhail N Kosiborod, David Z I Cherney, Jacob A Udell, Subodh Verma, R Preston Mason, Bertram Pitt and Ph Gabriel Steg, 14 February 2025, The Lancet Diabetes & Endocrinology.
Lexicon Pharmaceuticals funded the trial. The Icahn School of Medicine at Mount Sinai receives research funding from Lexicon Pharmaceuticals for Dr. Bhatt’s role as Chair of the SCORED trial.