New SGLT2 inhibitor non-inferior to placebo for CV outcomes
Results of the eValuation of ERTugliflozin EffIcacy and Safety CardioVascular Outcomes Trial (VERTIS-CV) trial presented at ADA’s 80th Scientific Sessions demonstrated that the SGLT2 inhibitor ertugliflozin did not reduce risk of CV events in T2DM patients with established CVD. Rate of primary endpoints were similar in patients treated with ertugliflozin and those on placebo (both 11.9%, P<0.001 for non-inferiority). Rate of hospitalization for heart failure (HF) was reduced in those treated with ertugliflozin compared to those on placebo. Safety profile was consistent with that of other SGLT2 inhibitors (rate of amputations was 0.6 per 100 patient years in ertugliflozin group vs. 0.5 in placebo group).
The relatively new member of the SGLT2 inhibitor class, ertugliflozin, has been approved as an adjunct to diet and exercise to improve glycemic control in T2DM patients. The VERTIS-CV trial, an international phase 3, randomized, parallel-group trial, was performed to evaluate CV safety of ertugliflozin. 8235 T2DM patients were enrolled, who had documented history of atherosclerosis involving the coronary, cerebral or peripheral vascular territories. Patients were randomized to 15 mg ertugliflozin, 5 mg ertugliflozin or placebo, once daily. Follow-up was 6.1 years. Primary endpoint was time to first occurrence of major adverse CV events, consisting of CV death, non-fatal myocardial infarction or non-fatal stroke.