Sotagliflozin SCORED cardiovascular risk reduction in people with type 2 diabetes, CKD
medwireNews: Add-on treatment with the sodium-glucose cotransporter (SGLT)1 and 2 inhibitor sotagliflozin may reduce cardiovascular (CV) risk among patients with type 2 diabetes and chronic kidney disease (CKD), suggest findings from the SCORED trial published in The New England Journal of Medicine.
The phase 3 study included 10,584 participants with glycated hemoglobin levels of 7% (53 mmol/mol) or higher, estimated glomerular filtration rate of 25–60 mL/min per 1.73 m2, and additional CV risk factors who were randomly assigned to receive sotagliflozin (200 mg/day, increased to 400 mg/day in those without unacceptable side effects) or placebo in addition to standard treatment.
Deepak Bhatt (Brigham and Women’s Hospital, Boston, Massachusetts, USA) and co-investigators found that the 5292 participants treated with the SGLT1/2 inhibitor had a significant 26% lower risk for the primary CV endpoint – a composite of death from CV causes, hospitalization for heart failure (HF), and urgent visits for HF – than the 5292 individuals given placebo. There were 400 primary endpoint events during a median follow-up of 16.0 months in the sotagliflozin group and 530 events over a median follow-up of 15.9 months in the placebo arm, translating into event rates of 5.6 versus 7.5 per 100 patient–years.
In a hierarchical analysis of secondary endpoints, patients treated with sotagliflozin had a significant 33% reduced risk for HF hospitalization or urgent visits for HF compared with those given placebo (3.5 vs 5.1 per 100 patient–years), but rates of CV death were not significantly different.
Bhatt and team note that their trial originally had a coprimary endpoint of major adverse CV events (CV death, nonfatal myocardial infarction, or nonfatal stroke) and death from CV causes or hospitalization for HF in a time-to-event analysis, but this was changed following loss of funding, which led to “fewer than planned number of events.” Rates of both original coprimary endpoints were significantly lower among sotagliflozin- versus placebo-treated patients.
The investigators say that there were no significant between-group differences in the overall proportion of patients who experienced adverse events. Participants treated with sotagliflozin were significantly more likely than those given placebo to experience diarrhea (8.5 vs 6.0%), diabetic ketoacidosis (0.6 vs 0.3%), genital mycotic infections (2.4 vs 0.9%), and volume depletion (5.3 vs 4.0%), but rates of bone fractures, urinary tract infections, severe hypoglycemia, and amputation were comparable in the two groups.
Bhatt and co-investigators conclude that “longer trials are needed to evaluate the effect and safety of sotagliflozin in patients with diabetes and chronic kidney disease.”
The SCORED findings were also presented at the virtual AHA Scientific Sessions 2020.
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