INTRODUCTION: Ertugliflozin is an inhibitor of sodium-glucose co-transporter 2 whose cardiovascular effects have not yet been established. The main objective of this clinical trial was to show the noninferiority of ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke).

METHOD: Ina multicentre, double-blind trial, patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned to receive 5 mgor 15 mg of ertugliflozin or placebo once a day. The data from the two dose groups were pooled and analysed. The noninferiority margin was 1.3.

RESULTS: The total study participants randomized were 8246 and the mean follow up period was 3.5 years. 8238 patients received at least one dose of ertugliflozin or placebo, major cardiovascular event occurred in 653 of 5493 patients (11.95) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97; 95.6% confidence interval [CI], 0.85 to 1.11; P<0.001for noninferiority). Death from cardiovascular causes or hospitalization for heart failure occurred in 444 of 5499 patients (8.1%) in the ertugliflozin group and in 250 of 2747 patients (9.1%) in the placebo group (hazard ratio,0.88; 95.8% CI, 0.75 to 1.03; P=0.11 for superiority). Amputations were done in 54 patients (2.0%) who were given 5-mg dose of ertugliflozin and in 57 patients (2.1%) who were given the 15 mg dose, as compared with 45 patients (1.6%) who received placebo.

CONCLUSION: Based on the results, the study authors concluded that among patients with type 2 diabetes and atherosclerotic cardiovascular disease, ertugliflozin was noninferior to placebo with regards to major adverse cardiovascular events.

Reference: Cannon CP, et al. Cardiovascular outcomes with ertugliflozin in type 2diabetes. N Engl J Med. 2020; 383(15): 1425.