SOTAGLIFLOZIN is a sodium–glucose cotransporter 2 (SGLT2) inhibitor that may reduce the risk of urgent medical care for heart failure, hospitalisation, and death caused by cardiovascular events in patients with diabetes and chronic kidney disease.
The new findings came after investigators randomised 10,584 patients to receive sotagliflozin 200 mg once daily, which was increased to 400 mg once daily if tolerated, or placebo. The cohort had a mean age of 69 years, 45% were female, HbA1c of ≥7%, and those aged 55 or older had at least one major or two minor cardiovascular risk factors. The primary endpoint of the study, revised during the study period, was a composite of deaths from cardiovascular causes and hospitalisations or urgent visits for heart failure. The results were favourable and showed that “sotagliflozin is the first SGLT2 inhibitor to show a beneficial effect on stroke among patients with diabetes, suggesting that it may also affect atherosclerosis, or plaque build-up in the coronary and brain arteries,” according to Dr Deepak Bhatt, Harvard Medical School in Boston, Massachusetts, USA.
The researchers found a 26% reduction risk in patients assigned to the sotagliflozin group, who experienced 5.6 events per 100 patient-years compared with 7.5 events per 100 patient-years in the placebo group; however, there was not a significant difference in deaths caused by cardiovascular events between the groups. Adverse events were more commonly experienced by the sotagliflozin group and included diarrhoea (8.5% versus 6.0%), diabetic ketoacidosis (0.6% versus 0.3%), genital mycotic infections (2.4% versus 0.9%), and volume depletion (5.3% versus 4.0%). Hypertension was experienced by a lower proportion of patients in the sotagliflozin group (2.6% versus 4.1%) and hypotension was experienced in a significantly higher proportion of those who received sotagliflozin (2.6% versus 1.9%).
“This is a major advance for patients with Type 2 diabetes and advanced kidney disease, and these results clearly demonstrate that SGLT2 inhibitors should become part of the standard of care,” claimed Dr Bhatt.