Beth Essig General Counsel | Mount Sinai Beth Israel
Beth Essig General Counsel | Mount Sinai Beth Israel
Sotagliflozin, a medication recently approved by the Food and Drug Administration, has shown significant potential in reducing heart attacks and strokes among patients with type 2 diabetes and kidney disease who also have additional cardiovascular risk factors. This finding comes from an international clinical trial led by a researcher at Mount Sinai.
Sotagliflozin is classified as a sodium-glucose cotransporter (SGLT) inhibitor. It works by blocking two proteins, SGLT1 and SGLT2, which play roles in moving glucose and sodium across cell membranes to help control blood sugar levels. Unlike other SGLT2 inhibitors, sotagliflozin more significantly blocks SGLT1.
The study was published on February 14 in The Lancet Diabetes & Endocrinology. It is the first to demonstrate that an SGLT inhibitor offers these specific cardiovascular benefits. According to Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, 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: “These results demonstrate a new mechanism of action—combined blockade with sotagliflozin of the SGLT1 receptors (found in the kidney, gut, heart, and brain) and SGLT2 receptors (found in the kidney)—to reduce heart attack and stroke risk.” He added that “the benefits seen here are distinct from those seen with the other very popular SGLT2 inhibitors in widespread clinical use for diabetes, heart failure, and kidney disease.”
The SCORED trial was randomized and multicenter in nature. It assessed sotagliflozin's ability to lower life-threatening cardiovascular outcomes among 10,584 patients suffering from chronic kidney disease and type 2 diabetes with additional cardiovascular risks. Participants were randomly assigned either sotagliflozin or a placebo over an average period of 16 months. The group receiving sotagliflozin experienced a 23 percent reduction in heart attacks, strokes, and deaths from cardiovascular causes compared to those given a placebo.
Dr. Bhatt noted: “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, chronic kidney disease, and other cardiovascular risk factors.” He emphasized that “this drug was approved to reduce the risk of deaths from cardiovascular causes,” adding that it may see more widespread use due to its ability to additionally reduce heart attacks and strokes.
The trial received funding from Lexicon Pharmaceuticals. The Icahn School of Medicine at Mount Sinai receives research funding from Lexicon Pharmaceuticals for Dr. Bhatt’s role as Chair of the SCORED trial.
Mount Sinai Fuster Heart Hospital ranks fourth nationally for cardiology and vascular surgery according to U.S. News & World Report. Additionally, it holds the top spot in New York based on Newsweek’s “The World’s Best Specialized Hospitals.” As part of New York City's largest academic medical system—the Mount Sinai Health System—it includes eight hospitals along with extensive ambulatory practices throughout the region.
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