The SGLT-2 inhibitor sotagliflozin reduced deaths from cardiovascular causes, hospitalizations, and urgent care visits, compared with placebo, without major safety issues.
Sotagliflozin is a sodium–glucose cotransporter-2 (SGLT-2) inhibitor that was approved in the European Union to treat patients with type 1 diabetes. But, to date, the agent has been rejected in the U.S. by the FDA because of safety concerns.
Now, investigators have conducted two parallel, industry-funded, international, double-blind, randomized, placebo-controlled, phase 3 trials to test whether sotagliflozin could reduce the risk for the composite primary endpoint of death from cardiovascular causes, hospitalization for heart failure (HF), and an urgent care visit for HF, in patients with diabetes and recent worsening of HF (the SOLOIST-WHF study; NCT03521934) and in patients with diabetes and chronic kidney disease (the SCORED study; (NCT0…
Reviewing Author
DisclosuresConsultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime
EquityHugo Health; Refactor Health; Element Science
Grant/Research SupportPfizer; Agency for Healthcare Research and Quality; Janssen Research and Development, National Institute of Biomedical Imaging and Engineering; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; National Cancer Institute; American Heart Association
DisclosuresConsultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime
EquityHugo Health; Refactor Health; Element Science
Grant/Research SupportPfizer; Agency for Healthcare Research and Quality; Janssen Research and Development, National Institute of Biomedical Imaging and Engineering; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; National Cancer Institute; American Heart Association