Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes
Abstract
This randomized, double-blind, multicenter trial (VERTIS CV) evaluated the long-term cardiovascular and renal safety of ertugliflozin a sodium-glucose cotransporter 2 (SGLT2) inhibitor in 8246 patients with type 2 diabetes and established atherosclerotic cardiovascular disease. Participants received either 5 mg or 15 mg of ertugliflozin or placebo daily. Over a mean follow-up of 3.5 years, ertugliflozin was noninferior to placebo regarding the primary endpoint: major adverse cardiovascular events (composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; HR: 0.97; 95.6% CI: 0.85–1.11; P<0.001 for noninferiority). Hospitalization for heart failure was numerically reduced (HR: 0.70; 95% CI: 0.54–0.90), but the composite secondary outcome of cardiovascular death or heart failure hospitalization did not reach superiority (P=0.11). Renal benefits were not statistically significant. Ertugliflozin led to modest improvements in glycemic control, weight, and systolic blood pressure, with increased rates of genital infections and diabetic ketoacidosis. The trial supports ertugliflozin’s cardiovascular safety but shows limited superiority compared to other SGLT2 inhibitors.
Keywords:
ertugliflozin
SGLT2 inhibitors
type 2 diabetes
cardiovascular outcomes
renal safety
randomized controlled trial
VERTIS CV
heart failure
glycemic control
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