Ertugliflozin Noninferior to Placebo for Cardiovascular Safety in VERTIS-CV

June 16, 2020

Lead investigator of VERTIS-CV discusses results of the phase 3 trial examining ertugliflozin's impact on cardiovascular health.

Better late than never might be the perfect adage to describe the VERTIS-CV trial—presented on the final day of the American Diabetes Association’s (ADA) 80th Scientific Sessions, results of the 8000-person trial demonstrate ertugliflozin (Steglatro) use did not increase risk of cardiac events.

A relatively new member of the SGLT2 inhibitor class, results of the trial demonstrate the safety and efficacy profile of ertugliflozin and suggests use of the agent could reduce the rate of heart failure hospitalizations, but was not superior to placebo for MACE.

“Our research supports the recent guideline updates indicating the use of this class of drugs for patients with diabetes who have prior atherosclerotic heart disease, heart failure, or chronic kidney disease. Patients with type 2 diabetes who have heart disease should discuss with their doctor whether SGLT2 inhibitors may be appropriate for their treatment,” said lead investigator of VERTIS-CV Christopher Cannon, MD, professor of medicine at Harvard Medical School and senior physician in the Cardiovascular Division at Brigham and Women’s Hospital, in a statement.

In an effort to determine the cardiovascular safety of ertugliflozin, Cannon and fellow investigators designed the “Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease,” study as an international phase 3, randomized, parallel-group study comparing ertugliflozin versus placebo. Beginning in 2013, the 8246-person trial enrolled participants with type 2 diabetes aged 40 and older with a history of atherosclerotic cardiovascular disease from within the US and 34 different countries.

Patients included in the trial were randomly assigned to receive either ertugliflozin 15 mg, ertugliflozin 5 mg, or placebo, once daily. Following randomization, patients were followed for up to 6.1 years to evaluate time to first occurrence of major adverse cardiovascular events. Cardiovascular outcomes of interest in the trial included cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.

Upon analysis, results indicated patients receiving ertugliflozin had similar rates of cardiovascular death, heart attack, or stroke as those receiving placebo. Specifically, the primary outcome occurred in 11.9% of patients in the ertugliflozin group and 11.9% of the placebo group (P <.001 for non-inferiority). Additionally, the observed safety profile of ertugliflozin seen in the trial was consistent with the known risks of other agents in the SGLT2 inhibitor class.

To gain further insight into the results of VERTIS-CV and the potential of ertugliflozin, HCPLive® reached out to Cannon to take part in a special edition ADA 2020 House Call.

&#8232;&#8232;

This study, “Results of the eValuation of ERTugliflozin EffIcacy and Safety CardioVascular Outcomes Trial (VERTIS-CV),” was presented at ADA 2020.