Phase III VERTIS CV trial with Steglatro meets endpoint in type 2 diabetes + CV.- Merck Inc and Pfizer

Merck Inc and Pfizer announced the presentation of results from the Phase III VERTIS CV cardiovascular (CV) outcomes trial that evaluated Steglatro (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, versus placebo, added to background standard of care treatment, in more than 8,200 patients with type 2 diabetes and atherosclerotic CV disease across 531 centers in 34 countries. The study met the primary endpoint of non-inferiority on major adverse CV events (MACE), which is composed of a composite of CV death, nonfatal myocardial infarction or nonfatal stroke, compared to placebo.

Overall, the primary MACE outcome was reported in 11.9% (n=653) of patients treated with Steglatro (5 mg and 15 mg doses), compared with 11.9% (n=327) of patients treated with placebo (HR=0.97; 95.6% CI [0.85-1.11]; p<0.001 for non-inferiority). The key secondary endpoints of superiority for ertugliflozin versus placebo were not met. These key secondary endpoints included: time to the first occurrence of the composite of CV death or hospitalization for heart failure (HHF), time to CV death alone and time to the first occurrence of the composite of renal death, dialysis/transplant or doubling of serum creatinine.

The pre-specified endpoint of HHF, while not a part of the hierarchical testing sequence, showed a 30% reduction in the risk of HHF for ertugliflozin versus placebo (2.5% vs. 3.6%; HR=0.70; 95% CI [0.54-0.90]). The safety profile of STEGLATRO was consistent with that reported in previous studies.