Sotagliflozin Reduces Stroke, MI, and CV Death, Regardless of CVD History

Data from an analysis of the SCORED trial presented at the American College of Cardiology’s 71st Annual Scientific Sessions demonstrate the ability of sotagliflozin, a dual SGLT1/2 inhibitor, to reduce risk of major adverse cardiovascular events in patient s with type 2 diabetes and chronic kidney disease.

Presented by principal investigator Deepak Bhatt, MD, MPH, results of the SCORED analysis demonstrate use of sotagliflozin was associated with a statistically significant reduction in the composite endpoint of total cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 26%, with the benefit of sotagliflozin reaching statistical significance by 3 months.

“This analysis demonstrated that in addition to reducing heart failure events, sotagliflozin reduced MACE events,” said Bhatt, in a statement from Lexicon Pharmaceuticals. “The lower rates of MACE, notably including reductions in both heart attack and stroke, were consistent in patients with and without cardiovascular disease at baseline.”

Originally presented alongside the SOLOIST-WHF trial, which examined use of sotagliflozin in patients with type 2 diabetes who were recently hospitalized for worsening heart failure, at AHA 2020, SCORED was a multicenter, double-blind, randomized clinical trial that enrolled 10,584 patients with type 2 diabetes, CKD, and cardiovascular risk and randomized them in a 1:1 ratio to sotagliflozin or placebo therapy.

Patients in the trial were followed for a median of 16 months and the primary endpoint was a composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure. Of note, the SCORED trial was ended early due to a lack of funding during the pandemic.

At AHA 2020, Bhatt presented data that demonstrated sotagliflozin was associated with a lower rate of primary endpoint events (HR, 0.74 [95% CI, 0.63-0.88]; P <.001) and a lower rate of deaths from cardiovascular causes (HR, 0.90 [95% CI, 0.73-1.12]; P=.35). Results also suggested sotagliflozin was associated with a reduction in first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (HR, 0.77 [95% CI, 0.65-0.91]; P=.002).

In the ACC.22 analysis presented by Bhatt, investigators assessed the risk of total MACE, total MI, and total stroke from the trial, with stratification based on history of cardiovascular disease. Results of the latest SCORED analysis suggested sotagliflozin was associated with a 21% relative risk reduction in total MACE, total MI, and total stroke among patients with a history of cardiovascular disease (HR, 0.79 [95% CI, 0.64-0.96]; P=.02) and a 26% relative risk reduction among patients without a history of cardiovascular disease (HR, 0.74 [95% CI, 0.56-0.99]; P=.046).

For total MI, results suggested sotagliflozin use reduced risk by 31% among those with a history of cardiovascular disease (HR, 0.69 [95% CI, 0.51-0.95]; P=.023) and by 34% among those without a history of cardiovascular disease (HR, 0.66 [95% CI, 0.41-1.06]; P=.088). For total stroke, risk was reduced by 31% in those with a history of cardiovascular disease (HR, 0.69 [95% CI, 0.46-1.02]; P=.063) and by 38% in those without a history of cardiovascular disease (HR, 0.62 [955 CI, 0.36-1.06]; P=.08).

To learn more about the results of the analysis and how it might inform the use of sotagliflozin in the future, we sat down with Bhatt at ACC.22 and that conversation can be found in the video below.

This study, “Sotagliflozin Significantly Reduces Cardiovascular Death, Myocardial Infarction, And Stroke In The Scored Trial,” was presented at ACC.22.