Findings from the VERTIS-CV trial looking at the safety and efficacy of ertugliflozin, one of the newer sodium-glucose cotransporter 2 (SGLT2) inhibitors, indicate that the drug does not impact the likelihood of heart attack, stroke, or cardiac death in patients with type 2 diabetes. The investigators also found that the rate of hospitalization for heart failure (HHF) was lower among study participants treated with ertugliflozin.
The findings were presented by a panel of trial investigators during the Virtual 80th Scientific Sessions symposium Results of the eValuation of ERTugliflozin EffIcacy and Safety CardioVascular Outcomes Trial (VERTIS-CV) on Tuesday, June 16. The presentation can be viewed by registered meeting attendees at ADA2020.org through September 10, 2020. If you haven’t registered for the Virtual 80th Scientific Sessions, register today to access all of the valuable meeting content.
“We summarize the main cardiovascular (CV) and renal outcomes to note that, in patients with type 2 diabetes and a prevalent atherosclerotic CV disease, ertugliflozin when added to guideline-directed secondary preventive therapies was noninferior versus placebo for the MACE (major adverse cardiovascular events) endpoint,” said Christopher P. Cannon, MD, a member of the VERTIS-CV trial Scientific Advisory Committee, who presented the main cardiovascular and renal outcomes of the trial.
Beginning in 2013, the VERTIS-CV trial enrolled 8,246 participants with type 2 diabetes throughout the U.S. and 34 countries worldwide aged 40 and older who had a documented history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems. The patients were randomly assigned to take a once-daily dose of ertugliflozin 15 mg (n=2,747), ertugliflozin 5 mg (n=2,752), or placebo (n=2,747). Participants were followed for up to 6.1 years to assess the time to the first occurrence of a major adverse cardiovascular event.
“The key secondary composite endpoint of CV death or hospitalization for heart failure did not differ significantly by group, nor did CV death, but a 30% lower risk of HHF was observed with ertugliflozin,” said Dr. Cannon, Education Director of Cardiovascular Innovation at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. “The renal composite was 19% lower, but this was not statistically significant for that defined endpoint. Looking at the overall pattern of the effects on these endpoints, in particular HHF and renal outcomes, we find that these are really in line with those seen in other large trials.”
While the researchers hoped the trial results would show more significant benefits, Dr. Cannon noted that the overall pattern of benefit is consistent with findings from other trials of SGLT2 inhibitors and provides further evidence supporting the cardiovascular benefits of the drug class.
“Our findings provide further evidence supporting the use of this class of drugs for the treatment of patients with type 2 diabetes who have prior atherosclerotic heart disease, heart failure, or chronic kidney disease, and highlights one of the biggest benefits is a reduction in the need to be hospitalized for heart failure,” Dr. Cannon said. “Patients with type 2 diabetes who have heart disease should discuss with their doctor whether SGLT2 inhibitors may be appropriate for their treatment.”