VERTIS-CV: Similar MACE risk with ertugliflozin vs placebo in type 2 diabetes
medwireNews: Patients with type 2 diabetes and established atherosclerotic disease who are treated with the sodium-glucose cotransporter (SGLT)2 inhibitor ertugliflozin have a similar risk for major adverse cardiovascular events (MACE) to those given placebo, shows the VERTIS-CV trial.
The phase 3 cardiovascular (CV) outcomes trial met the primary noninferiority endpoint, but did not demonstrate superiority of ertugliflozin over placebo for CV or renal outcomes, reported Christopher Cannon (Brigham and Women’s Hospital, Boston, Massachusetts, USA) at the virtual ADA 80th Scientific Sessions.
In all, 11.9% of 5499 participants who were randomly assigned to receive once-daily treatment with ertugliflozin 5 mg or 15 mg alongside background standard therapy experienced the primary endpoint of MACE, a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke.
The incidence of the three-point MACE endpoint was also 11.9% for the 2747 patients who instead received placebo in addition to standard therapy, giving a hazard ratio of 0.97. The upper bound of the 95.6% confidence interval met the criteria for noninferiority, said Cannon.
He noted that the results were “largely similar” when the two doses of ertugliflozin were analyzed separately.
In the analysis of key secondary outcomes, the risk for CV death or hospitalization for heart failure (HHF) was 8.1% in the ertugliflozin arm and 9.1% in the placebo arm, a nonsignificant difference. Rates of CV death were also comparable in the two arms (6.2 vs 6.7%), as were rates of the renal composite outcome of renal death, dialysis/transplant, or doubling of serum creatinine (3.2 vs 3.9%).
Cannon said that there was a trend for a lower HHF risk among ertugliflozin- versus placebo-treated patients, with rates of 2.5% versus 3.6%, but the difference was not statistically significant due to the hierarchical testing sequence used.
Reporting the safety data, co-investigator Darren McGuire (University of Texas Southwestern Medical Center, Dallas, USA) said that ertugliflozin was well tolerated overall, with “a safety profile consistent with known risks of the SGLT2 inhibitor class.”
A total of 85.8%, 84.6%, and 85.6% of patients in the ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo groups, respectively, experienced adverse events (AEs), and the corresponding rates of serious AEs were 34.9%, 34.1%, and 36.1%.
Participants given ertugliflozin were more likely to experience urinary tract infections and genital mycotic infections than those in the placebo arm, while rates of acute kidney injury and diabetic ketoacidosis were comparable in all groups.
McGuire reported that the frequency of amputation was “low” overall, but was numerically higher in the ertugliflozin 5 mg and 15 mg arms compared with the placebo group (2.1 and 2.0 vs 1.6%).
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