Data reinforce unique clinical advantages of sotagliflozin
Published study is aligned with research presented in December 2024 at the American Society of Hematology showing clinical benefits of sotagliflozin compared to empagliflozin
Feb. 18, 2025 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced The Lancet Diabetes & Endocrinology has published a research paper analyzing the ability of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce the risks of life-threatening cardiovascular outcomes.
The findings from the study, “Reduction in Major Adverse Cardiovascular Events with Sotagliflozin: A Prespecified Analysis of the SCORED Randomized Trial,” concluded that the ischemic benefit of sotagliflozin on both heart attack (myocardial infarction, or MI), and stroke reduction has not been shown by other SGLT inhibitors. The researchers note that sotagliflozin reduced major adverse cardiovascular events (MACE), MI, and stroke among patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular (CV) risk.
The study was a secondary analysis of SCORED, a double-blind, placebo-controlled, randomized clinical trial enrolling patients with T2D and CKD. A pre-specified outcome was total MACE, which was defined as a composite of total CV death, nonfatal MI, and nonfatal stroke. Other outcomes included total MI and total stroke.
Patients in the sotagliflozin group had a lower rate of MACE outcomes (4.8 events per 100 person-years [p-y]) compared with the placebo group (6.3 events per 100 p-y) (hazard ratio [HR]: 0.77; 95% confidence interval [CI]: 0.65-0.91; P=0.002). MACE benefit was consistent across pre-specified subgroups. Additionally, sotagliflozin reduced the rate of MI (1.8 events per 100 p-y) compared with the placebo group (2.7 events per 100 p-y) (HR: 0.68; 95% CI: 0.52-0.89; P=0.004) and of stroke (1.2 events per 100 p-y vs 1.8 events per 100 p-y) (HR: 0.66, 95% CI: 0.48-0.91, P=0.012).
“Our research team found that sotagliflozin is the only SGLT inhibitor to demonstrate significant reduction of both heart attack and stroke,” said Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, Director, of the Mount Sinai Fuster Heart Hospital, and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, New York, NY. The Icahn School of Medicine receives research funding for Dr. Bhatt’s role as the Chair of SCORED.
“When you look at the published and presented findings holistically, you get a clear picture of how and why sotagliflozin stands apart from all other SGLT inhibitors,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com.
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