Sotagliflozin use linked to reduced risk of heart attack, heart failure and stroke in diabetics: Study

Sotagliflozin is not FDA approved and if it is brought to the market, it would signify a major advance in the care of patients with diabetes, especially those with heart failure or kidney disease. 

USA: Early use of sotagliflozin may reduce the risk of heart failure, heart attack, and stroke in type 2 diabetes patients with chronic kidney disease or heart failure, show results from two large clinical trials. Sotagliflozin is a drug that inhibits sodium-glucose transport protein 2 (SGLT2) and sodium-glucose transport protein 1 (SGLT1). 

The findings from the SCORED and SOLOIST trials were presented at the 81st Scientific Sessions of the American Diabetes Association (ADA).

Patients with diabetes are at an increased risk of life-threatening conditions such as chronic kidney disease and heart failure. In fact, diabetes is the leading cause of kidney failure1 and the rate of heart failure for patients with diabetes is four times higher than the general population—highlighting the need to address these comorbidities within standard of care.

Less than a decade ago, the Food and Drug Administration (FDA) approved drugs for treating type 2 diabetes in an entirely new way using SGLT2 inhibitors to help the body eliminate blood sugar via urine, offering enhanced blood sugar (blood glucose) control, cardiovascular benefits, and weight loss for people with diabetes taking the drug. Another effective and complementary mechanism of action uses SGLT1 inhibition to reduce blood sugar via the digestive tract. Combination SGLT2 and SGLT1 inhibitors are currently being studied and none have been approved by the FDA.

Building on the evidence of this new class of drugs, the SCORED and SOLOIST trials evaluate the benefits of a combination drug that inhibits both SGLT2 and SGLT1 in patients experiencing kidney failure or heart failure.

Trial data come from SOLOIST, which randomized 1,222 people with type 2 diabetes who had been recently hospitalized for worsening heart failure. SCORED, a much broader 10,584 patient trial, studied the drug's ability to prevent cardiovascular events in people with diabetes and chronic kidney disease. Both studies were published in The New England Journal of Medicine and demonstrate the benefit of using an SGLT1/2 inhibitor drug for people with type 2 diabetes. 

"The results presented today add to the growing body of evidence demonstrating the overall benefit of this new class of glucose-lowering agents. It is now clear that most patients with type 2 diabetes and either kidney disease or heart failure should be assessed for initiation of an SGLT inhibitor," said Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital, and Professor of Medicine, Harvard Medical School. "Our findings are the first of their kind, with this investigational drug demonstrating a benefit in people with diabetes across all the different types of heart failure." 

The authors indicate that sotagliflozin is not FDA approved and that if it is brought to the market, it would signify a major advance in the care of patients with diabetes, especially those with heart failure or kidney disease.