Merck, known as MSD outside the United States and Canada, and Pfizer Inc. announced the presentation of results from the Phase 3 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.
“The VERTIS CV results add to the growing body of evidence regarding the clinical profile of ertugliflozin, including its safety in patients with a history of cardiovascular disease,” said Dr. Christopher P. Cannon, cardiologist at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, the study’s lead author. “Although not a part of the hierarchical testing sequence, the results indicated the potential of ertugliflozin to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease.”
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 results of the VERTIS CV trial are a significant and important addition to the overall evidence for the cardiovascular safety profile of ertugliflozin,” said Dr. Sam Engel, associate vice president, Merck clinical research, diabetes and endocrinology.
“We sincerely thank the patients and investigators for their participation in the VERTIS CV study and commitment to the clinical evaluation of ertugliflozin,” said Dr. James Rusnak, senior vice president and chief development officer, internal medicine, Pfizer Global Product Development.
The safety profile of STEGLATRO was consistent with that reported in previous studies.
STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The results of VERTIS CV trial were presented today at the American Diabetes Association’s virtual 80th Scientific Sessions.