Researchers at the 81st Scientific Sessions will present the most comprehensive look yet at data from recent clinical trials of sotagliflozin, the first combined sodium-glucose cotransporter-1 (SGLT1) and SGLT2 inhibitor in phase 3 randomized controlled clinical trials. Initial results of the Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) and the Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trials were published in the New England Journal of Medicine in January 2021.
“We will go into greater detail and present new data on glycemic control as a function of glomerular filtration rate (GFR) and the effects on heart failure across the entire range of ejection fraction,” said Deepak Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart & Vascular Center and Professor of Medicine at Harvard Medical School. “We will also present data on days alive and out of hospital, an important patient-centered metric. And there will be data for sotagliflozin in type 1 diabetes that has not been fully discussed before.”
Dr. Bhatt is the lead author of the SCORED trial that investigated sotagliflozin in patients with diabetes and chronic kidney disease. He is part of a special Update on SCORED and SOLOIST Cardiovascular and Kidney Outcomes Trials symposium on Tuesday, June 29, from 10:15 a.m. – 12:15 p.m. ET that will include a live question-and-answer period.
SGLT1 and SGLT2 inhibition occurs in the kidneys, but SGLT1 inhibition also works in the gut, leading to decreases in postprandial glucose levels, Dr. Bhatt said. This combined activity may be of particular benefit in patients with impaired kidney function. SGLT2 inhibition is less effective as kidney function declines and is contraindicated if estimated GFR is 30 or below.
“It is likely to be the case that sotagliflozin will do a better job for glycemic control in patients with diminished estimated GFR than pure SGLT2 inhibitors that are currently available,” Dr. Bhatt said. “As was demonstrated in the SOLOIST trial, sotagliflozin produced significant reductions in heart failure, while we additionally demonstrated reductions in heart attack and stroke in the SCORED trial.”
Sotagliflozin is the first SGLT inhibitor to demonstrate significant activity against stroke, he continued. It is not yet clear if the stroke benefits for patients with diabetes were due to the drug, the patient population enrolled in SCORED, or a combination of factors.
The resounding success of combined SGLT1 and SGLT2 inhibition opens up new avenues for future research, Dr. Bhatt said. SGLT1 inhibition could be a pathway to greater clinical benefit to the heart, kidneys, brain, and other related endpoints than is typically seen from SGLT2 inhibition alone.
Dr. Bhatt said the manufacturer has announced it will use the strong data supporting sotagliflozin to submit the drug for approval by the U.S. Food and Drug Administration.
“Potentially we will have a new addition to the armamentarium of drugs for patients with diabetes—something that’s not just another SGLT2 inhibitor,” he said. “By the end of this session, we will have a very good idea of the effect that adding SGLT1 inhibition might have in our patients with diabetes and different types of kidney and cardiovascular disease.”