Ertugliflozin Noninferior for CV Outcomes in T2DM With ASCVD
Ertugliflozin is noninferior to placebo for the primary end point of major adverse cardiovascular events
THURSDAY, Oct. 15, 2020 (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 Oct. 8 in the New England Journal of Medicine.
Christopher P. Cannon, M.D., 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 15 mg) or placebo once daily. Data from the two 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 8,238 patients received at least one dose of ertugliflozin or placebo and were included in the analyses.
The researchers found that a major cardiovascular event occurred in 11.9 percent of both the ertugliflozin and placebo groups (hazard ratio, 0.97; 95.6 percent 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 percent of patients in the ertugliflozin and placebo groups, respectively (hazard ratio, 0.88; 95.8 percent 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.