Sotagliflozin is beneficial for the treatment of type 2 diabetes in patients with recent worsening heart failure as well as in patients with chronic kidney disease, according to two studies published online in the New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions 2020.
Deepak L. Bhatt, MD, MPH, from the Brigham and Women’s Hospital Heart and Vascular Center in Boston, and colleagues randomly assigned 1,222 patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure to either sotagliflozin or placebo (608 and 614 patients, respectively). The researchers found that the rate of primary end point events (total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure) was lower in the sotagliflozin versus placebo group (51.0 versus 76.3 events per 100 patient-years; hazard ratio, 0.67). The trial ended early due to COVID-19-related loss of funding.
In a second study, Bhatt and colleagues randomly assigned patients with type 2 diabetes mellitus, chronic kidney disease, and risks for cardiovascular disease to receive either sotagliflozin or placebo (5,292 patients in each group). The researchers found that the rate of primary end-point events (composite of total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure) was 5.6 and 7.5 events per 100 patients-years in the sotagliflozin and placebo groups, respectively (hazard ratio, 0.74). The trial ended early due to COVID-19-related loss of funding.
“With the results of these large two trials, adding to other recent data about drugs in this class, it is now clear that most patients with type 2 diabetes and either kidney disease or heart failure should be on an SGLT2 inhibitor,” Bhatt said in a statement.
Several authors disclosed financial ties to biopharmaceutical companies, including Sanofi, which initially funded the study, and Lexicon Pharmaceuticals (the developer of sotagliflozin), which subsequently funded the study.