Research Highlights:

  • Sotagliflozin – a type of medication known as an SGLT2 inhibitor primarily prescribed for Type 2 diabetes – reduces the risk of adverse cardiovascular events for patients with diabetes and kidney disease.
  • Researchers say the results of this randomized clinical trial provide evidence that SGLT2 inhibitors should be part of the standard of care for people with Type 2 diabetes and chronic kidney disease.

Embargoed until 8:06 p.m. CT/9:06 p.m. ET, Monday, Nov. 16, 2020

DALLAS, Nov. 16, 2020 — A novel diabetes medication significantly reduces the risk of hospitalization for heart failure, heart attack and stroke, in patients with Type 2 diabetes and chronic kidney disease, according to late breaking research presented today at the American Heart Association’s Scientific Sessions 2020. The virtual meeting is Friday, November 13-Tuesday, November 17, 2020, and is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science for health care worldwide.

SGLT2 inhibitors are a class of medications that are prescribed to lower blood sugar in adults with Type 2 diabetes. Sotagliflozin is the first dual SGLT2/1 inhibitor developed for the management of both Type 1 and Type 2 diabetes.

“People with Type 2 diabetes have higher rates of cardiovascular and kidney disease and more serious complications,” said lead study author Deepak L. Bhatt, M.D., M.P.H., FAHA, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart & Vascular Center and professor of medicine at Harvard Medical School. “Recent trials of other SGLT2 inhibitors have consistently shown reductions in heart failure, and we wanted to assess the safety and efficacy of sotagliflozin in adults with Type 2 diabetes and chronic kidney disease.”

Researchers conducted a randomized, placebo-controlled, multicenter study to investigate the effects of sotagliflozin. In the SCORED trial, more than 10,000 people (average age 69, 45% women, 17% non-white) with Type 2 diabetes and chronic kidney disease were randomized to receive either sotagliflozin or placebo.

Although the trial ended earlier than planned due to loss of funding during the COVID-19 pandemic, results after an average follow up period of 16 months indicate numerous benefits for patients receiving sotagliflozin:

  • There was a significant 26% decrease in the total number of cardiovascular deaths, hospitalizations for heart failure or urgent visits for heart failure.
  • A significant reduction in the total number of heart attacks and strokes was achieved.
  • There was a significant reduction in blood glucose levels in patients with moderately to severely reduced kidney function.

Bhatt added, “Sotagliflozin is the first SGLT2 inhibitor to show a beneficial effect on stroke among patients with diabetes, suggesting that it may also affect atherosclerosis, or plaque build-up in the coronary and brain arteries. SCORED is also the first trial to show the benefits of SGLT2 inhibitors across the full range of albuminuria, or leakage of protein in the urine, which is common in people with Type 2 diabetes.

“This is a major advance for patients with Type 2 diabetes and advanced kidney disease, and these results clearly demonstrate that SGLT2 inhibitors should become part of the standard of care,” he said.

Co-authors are Michael Szarek, Ph.D.; Bertram Pitt, M.D.; Christopher P. Cannon, M.D.; Lawrence A. Leiter, M.D.; Darren K. McGuire, M.D., M.H.Sc.; Julia B. Lewis, M.D.; Matthew C. Riddle, M.D.; Silvio E. Inzucchi, M.D.; Mikhail N. Kosiborod, M.D.; David Z. I. Cherney, M.D., Ph.D.; Jamie P. Dwyer, M.D.; Benjamin M. Scirica, M.D., M.P.H.; Clifford J. Bailey, Ph.D.; Rafael Díaz, M.D.; Kausik K. Ray, M.D.; Jacob A. Udell, M.D., M.P.H.; Renato D. Lopes, M.D., Ph.D.; Pablo Lapuerta, M.D.; and Ph. Gabriel Steg, M.D. Author disclosures are in the abstract.

The study was funded initially by Sanofi and subsequently by Lexicon Pharmaceuticals.

Note: Session: LBS.07 - Randomized Trials – Brain, Kidney, and Heart

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