Sotagliflozin tied to reduced risk of MACE in patients with diabetes and CKD: SCORED Trial

USA: Results from SCORED trial sheds light on the potent effect of the investigational SGLT1&2 inhibitor sotagliflozin on major cardiovascular adverse events in patients with diabetes and chronic kidney disease, with or without albuminuria. The results were presented at the annual scientific sessions of the American College of Cardiology by Deepak L. Bhatt. 

In prespecified, secondary analyses of the SCORED results, it was shown that sotagliflozin treatment during a median of 16 months was associated with a significant 21% risk reduction compared to placebo for the combined incidence of total major adverse cardiovascular events (MACE), which included cardiovascular death, first and recurrent episodes of nonfatal MI, and nonfatal stroke. This was seen among the 5,144 randomized patients who entered the trial with a history of cardiovascular disease (CVD).

Treatment with sotagliflozin was linked to a significant 26% relative risk reduction in total MACE events among the 5,440 patients in the study who did not have a CVD history. 

Part of these overall MACE benefits resulted from similar improvements from sotagliflozin treatment on the individual outcomes of total nonfatal MI and total nonfatal strokes. Treatment with sotagliflozin cut these MIs by a significant 31% in patients with a history of CVD relative to patients who received placebo, and by a relative 34% in those without a CVD event in their history, a difference compared with placebo that fell short of significance, said Dr. Bhatt, professor of medicine at Harvard Medical School and executive director of interventional cardiovascular programs at Brigham and Women's Health, both in Boston.

Also, treatment with sotagliflozin cut total nonfatal strokes by 31% relative to placebo in patients with a history of CVD, and by a relative 38% in those without a CVD history. Both differences fell short of significance. 

The SGLT1 receptor is the primary mechanism cells in the gut use to absorb glucose and galactose in the human gastrointestinal tract, Dr. Bhatt explained, while the SGLT2 receptor appears on kidney cells and is the major player in the reabsorption of filtered glucose.

KEYWORDS: sotagliflozin, type 2 diabetes, chronic kidney disease, CKD, SCORED trial, major adverse cardiovascular events, MI, myocardial infarction, stroke, SGLT2 inhibitor, SGLT1 inhibitor, MACE, cardiovascular disease