Early Use of Sotagliflozin Demonstrates Benefits for Patients with Diabetes and Chronic Kidney Disease, Heart Failure

Two large clinical trials have found significant and early benefits from the use of sotagliflozin (Zynquista; Lexicon Pharmaceuticals) in reducing heart failure, heart attack, and stroke among adults with diabetes, according to findings presented at the virtual 81st Scientific Sessions of the American Diabetes Association (ADA).

Sotagliflozin is an investigational drug that inhibits sodium-glucose transport protein 1 (SGTP1) and sodium-glucose transport protein 2 (SGTP2). The drug works to reduce risks of heart problems and stroke, which are major problems in patients with diabetes. According to the ADA, diabetes is a leading cause of kidney failure and the rate of heart failure for patients with diabetes is 4 times higher than the general population.

Drugs to treat type 2 diabetes using SGLT2 inhibitors are relatively new, with FDA approvals only within the last decade. These inhibitors help the body eliminate blood sugar via urine, thereby improving blood glucose control, cardiovascular benefits, and weight loss for individuals with diabetes. Similarly, SGLT1 inhibition reduces blood sugar via the digestive tract, and combination inhibitors are being investigated.

To provide more evidence supporting this new class of drugs, the SCORED and SOLOIST clinical trials are evaluating the benefits of a combination drug that inhibits both SGLT2 and SGLT1 in patients experiencing kidney failure or heart failure.

The SOLOIST trial randomized 1222 patients with type 2 diabetes who had been recently hospitalized for worsening heart failure. The SCORED trial was much larger, with 10,584 patients. It studied the investigative drug’s ability to prevent cardiovascular events in individuals with diabetes and chronic kidney disease. Both studies were published in The New England Journal of Medicine and illustrate that SGLT1/2 inhibitors can have significant benefits.

“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,” said Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, in a press release.

The SCORED trial results illustrated that SGLT1/2 inhibitors can provide benefits across the full range of albuminuria, which is a symptom of kidney disease that involves an excess of protein in urine. Researchers also found that the inhibitors decreased the chance of heart attack by 32% and of stroke by 34%.

The SOLOIST trial results found that SGLT1/2 inhibitors were safe and effective when initiated in patients hospitalized with acute failure. Furthermore, they found that SGLT2 inhibition is safe and effective for early, inpatient initiation in patients with type 2 diabetes and heart failure, and reduces the risk of death from cardiovascular causes and hospitalization or urgent visits for heart failure by 33%.

“The results presented today add to the growing body of evidence demonstrating the overall benefit of this new class of glucose-lowering agents,” Bhatt said in the press release. “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.”

REFERENCE

Early Use of Sotagliflozin Provides Benefits for People With Type 2 Diabetes With Chronic Kidney Disease or Heart Failure. News release. 81st Scientific Sessions of the American Diabetes Association. June 29, 2021. Email.