Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes
Abstract
This multicenter, double blind trial evaluated the cardiovascular effects of ertugliflozin, an SGLT2 inhibitor, in patients with type 2 diabetes and atherosclerotic cardiovascular disease. A total of 8246 patients were randomized to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. The primary outcome was major adverse cardiovascular events (MACE), with a noninferiority margin of 1.3. Results showed that ertugliflozin was noninferior to placebo for MACE (hazard ratio, 0.97; 95.6% CI, 0.85–1.11; P < 0.001). The key secondary outcome of cardiovascular death or hospitalization for heart failure did not reach statistical significance (hazard ratio, 0.88; 95.8% CI, 0.75–1.03; P = 0.11). Ertugliflozin demonstrated safety consistent with the SGLT2 inhibitor class, with increased genital mycotic infections but no significant difference in amputations or renal outcomes compared to placebo.