Study: No Link Between Ertugliflozin and Increased Risk of Cardiac Events

Ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, does not impact the likelihood of stroke, heart attack, or cardiac related death in patients with type 2 diabetes (T2D), a new phase 3 study has found.

Ertugliflozin is a relatively new addition to the SGLT2 inhibitor class of medication, according to the investigators. Usually, ertugliflozin is prescribed along with a diet and exercise program meant to improve glycemic control in those with T2D, according to the study’s presentation at the American Diabetes Association’s (ADA) 80^th Virtual Scientific Sessions.

The study—“Results of the eValuation of ERTugliflozin EffIcacy and Safety CardioVascular Outcomes Trial (VERTIS-CV)”—was composed of 8246 individuals aged 40 years and older. Each participant had T2D and a documented history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems. The participants were randomly divided into 3 groups. The first group, which was made up of 2747 participants, received 15 mg of ertugliflozin. The second group, made up of 2752 participants, received 5 mg. The third group, made up of the remaining 2747 participants, received a placebo.

Researchers found that those taking ertugliflozin had similar rates of cardiovascular death, heart attack, and stroke. Of the 5493 patients taking ertugliflozin, the primary outcome occurred in 653 individuals or 11.9%. The primary outcome occurred in 327 members (11.9%) of the placebo group, according to researchers. While ertugliflozin alone did not prove to decrease overall risk of cardiovascular death or hospitalization, the study results showed those taking ertugliflozin had a lower rate of heart failure and hospitalization compared to the placebo group.

“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 VERTIS-CV researcher Christopher Cannon, MD, professor of medicine at Harvard Medical School, Senior Physician in the Cardiovascular Division at Brigham and Women’s Hospital, and Education Director at the Cardiovascular Innovation Group, in a press release.

The safety of ertugliflozin is consistent with other SGLT2 inhibitors, according to the press release. The rates of amputations were 0.6 and 0.5 per 100 patient years.

REFERENCE

International Study of More Than 8,000 People Showed Ertugliflozin Does Not Increase Risk of Cardiac Events [news release]; Chicago IL June 16, 2020; American Diabetes Association; Accessed June 17, 2020