Sotagliflozin could be used to reduce the risk of deadly cardiovascular events, trial shows

Sotagliflozin, a drug recently approved by the Food and Drug Administration to treat type 2 diabetes and kidney disease with additional cardiovascular risk factors, can significantly reduce heart attack and stroke among these patients, according to results from an international clinical trial led by a Mount Sinai researcher.

Sotagliflozin is a sodium-glucose cotransporter (SGLT) inhibitor. It blocks the function of two proteins, known as SGLT1 and SGLT2, which move glucose and sodium across cell membranes and help control blood sugar levels. Other SGLT2 inhibitors do not as significantly block SGLT1.

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.

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. 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."

Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, Study Chair, 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 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."

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.