Sotagliflozin the first drug of its kind to limit heart attacks, strokes in high-risk patients
Treatment with sotagliflozin can significantly reduce the risk of adverse cardiovascular events in patients with type 2 diabetes, chronic kidney disease (CKD) and additional cardiovascular risk factors, according to new research published in The Lancet Diabetes & Endocrinology.[1]
Sotagliflozin is a dual sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor developed by Texas-based Lexicon Pharmaceuticals and sold under the brand name Inpefa. It first gained U.S. Food and Drug Administration (FDA) approval to treat heart failure in certain high-risk patient populations in 2023.
For this new analysis, researchers tracked data from more than 10,000 patients who presented with type 2 diabetes, CKD and additional cardiovascular risks. Patients were randomly assigned to either receive treatment with sotagliflozin or a placebo. Overall, after a median follow-up period of 14 months, sotagliflozin was associated with a 23% reduction in a patient’s risk of experiencing a major adverse cardiovascular event (MACE), including a myocardial infarction, stroke or cardiovascular death. There were also significant reductions in the individual risks of myocardial infarction and stroke.
Researchers noted that other SGLTI inhibitors, including dapagliflozin and empagliflozin, have never been linked to such significant reductions in MACE risk; this represents a breakthrough for this specific class of heart drugs.
“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, CKD and other cardiovascular risk factors,” study chair Deepak L. Bhatt, MD, MPH, MBA, 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, said in a statement. “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, CKD, 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 this research.
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.