Ertugliflozin is a sodium-dependent glucose cotransporter (SGLT) inhibitor drug used as a monotherapy and a fix-dose treatment for diabetes. Though recent studies have validated the efficacy of ertugliflozin, it’s cardiovascular effects have not been studied. This study aims to investigate the cardiovascular effects of ertugliflozin in patients with type-2 diabetes.
This multicenter, double-blind trial included a total of 8,238 patients with type-2 diabetes and atherosclerotic cardiovascular disease (ACD). The patients were randomly assigned in a 2:1 ratio to receive 5 mg or 15 mg of ertugliflozin (n=5,493) or placebo (n=2,745). The primary outcome of the study was the noninferiority of ertugliflozin to placebo with respect to major adverse cardiovascular events.
Of 8,238 patients who underwent randomization, 653 (11.9%) in the ertugliflozin group, and in 327 (11.9%) in the placebo group experienced a major adverse cardiovascular event. Death due to cardiovascular causes was reported in 444 patients (8.1%) in the ertugliflozin group and 250 patients (9.1%) in the placebo group. The hazard ratio (HR) was 0.2 for cardiovascular death and 0.81 for death due to renal causes.
The research concluded that treatment with ertugliflozin was non-inferior to placebo with respect to cardiovascular outcomes in patients with type-2 diabetes and ACD.