Primary endpoint of non-inferiority met for SGLT2i in CV outcomes trial
The phase 3 VERTIS CV outcomes trial with the SGLT2 inhibitor ertugliflozin has achieved its primary endpoint of non-inferiority for MACE in T2DM patients with established ASCVD.
News - May 14, 2020The primary endpoint of non-inferiority for major adverse CV events (MACE) was met for the SGLT2 inhibitor ertugliflozin compared to placebo in the VERTIS CV outcomes trial. The trial enrolled T2DM patients with established atherosclerotic CVD (ASCVD). MACE was defined as a composite endpoint of CV death, nonfatal myocardial infarction or nonfatal stroke.
Key secondary endpoints of superiority for ertugliflozin compared to placebo for the composite of CV death or hospitalization for heart failure, CV death alone and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met. Hospitalization for HF was reduced with ertugliflozin compared to placebo.
The safety profile of ertugliflozin was consistent with that observed in previous trials.
More details will be presented at the virtual American Diabetes Association’s 80th Scientific Session on June 16, 2020.