The FDA-approved drug sotagliflozin demonstrates significant cardiovascular benefits for patients with type 2 diabetes and chronic kidney disease, according to groundbreaking research published in The Lancet Diabetes & Endocrinology on February 14.
The international clinical trial, known as SCORED, revealed a remarkable 23 percent reduction in heart attacks, strokes, and cardiovascular-related deaths among patients treated with sotagliflozin compared to placebo. This dual sodium-glucose cotransporter (SGLT) inhibitor targets both SGLT1 and SGLT2 proteins, marking a novel approach to cardiovascular risk reduction.
Innovative Mechanism of Action
"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," explains study chair Dr. Deepak L. Bhatt, Director of Mount Sinai Fuster Heart Hospital.
The drug's unique dual-inhibition mechanism distinguishes it from currently available SGLT2 inhibitors, potentially offering additional benefits for patients at risk of cardiovascular events.
Clinical Trial Design and Outcomes
The SCORED trial enrolled 10,584 patients with chronic kidney disease, type 2 diabetes, and additional cardiovascular risk factors. Participants were randomly assigned to receive either sotagliflozin or placebo and were followed for an average of 16 months.
The study's robust design and significant outcomes provide strong evidence for sotagliflozin's effectiveness in reducing multiple cardiovascular risks, including:
- Heart failure
- Progression of kidney disease
- Heart attacks
- Strokes
- Cardiovascular-related deaths
Clinical Implications
Dr. Bhatt emphasizes the drug's broad potential: "Physicians now have a new option to reduce global cardiovascular risk in patients with either heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors."
The FDA approval encompasses risk reduction for:
- Cardiovascular-related deaths
- Hospitalizations for heart failure
- Urgent heart failure visits
These findings suggest potential expanded use of sotagliflozin in clinical practice, particularly given its demonstrated ability to reduce heart attacks and strokes in this high-risk patient population.
The research was funded by Lexicon Pharmaceuticals, with the Icahn School of Medicine at Mount Sinai receiving research funding for Dr. Bhatt's role as Chair of the SCORED trial.
