HealthDay News – Ertugliflozin is noninferior to placebo with respect to major adverse cardiovascular events among patients with type 2 diabetes and atherosclerotic cardiovascular disease, according to a study published online October 8 in the New England Journal of Medicine.
Christopher P. Cannon, MD, from Brigham and Women’s Hospital in Boston, and colleagues conducted a multicenter, double-blind trial in which patients with type 2 diabetes and atherosclerotic cardiovascular disease were randomly assigned to receive either ertugliflozin (5 or 15mg) or placebo once daily. Data from the 2 ertugliflozin dose groups were pooled for analysis to examine the noninferiority of ertugliflozin to placebo with respect to the primary outcome of major adverse cardiovascular events. A total of 8238 patients received at least 1 dose of ertugliflozin or placebo and were included in the analyses.
The researchers found that a major cardiovascular event occurred in 11.9% of both the ertugliflozin and placebo groups (hazard ratio, 0.97; 95.6% confidence interval, 0.85 to 1.11; P <0.001 for noninferiority). Death from cardiovascular causes or hospitalization for heart failure occurred in 8.1 and 9.1% of patients in the ertugliflozin and placebo groups, respectively (hazard ratio, 0.88; 95.8% confidence interval, 0.75 to 1.03; P = 0.11 for superiority).
“We do not have a clear explanation about why our results did not reach significance, whereas significance was reached for many (but not all) end points in previous cardiovascular outcomes trials of SGLT2 [sodium-glucose cotransporter 2] inhibitors,” the authors write.
The study was funded by Merck Sharp & Dohme and Pfizer. Several authors disclosed ties to the pharmaceutical industry.