A study evaluating the cardiovascular and renal outcomes of erthglyphrosin in patients with type 2 diabetes

Reviewed by Emily Henderson, B.Sc.September 25, 2020

A new study led by a cardiologist at Brigham and Women’s Hospital evaluated the cardiovascular and renal outcomes of the SGLT2 inhibitor ertugliflozin. Type 2 diabetic patients They help control blood sugar levels.

Evaluation of Erzgriflozin efficacy The Safety Cardiovascular Outcome Study (VERTIS CV) showed that the safety profile of this drug was similar to that of other SGLT2 inhibitors and did not increase the risk of major adverse events compared to placebo.

The results showed no statistically significant benefit, but together with other recent studies on SGLT2 inhibitors, the study results show that this class of drugs can be used to prevent adverse cardiovascular outcomes. We are increasing the number of evidences that support useful guidelines. The discovery of their research New England Journal of Medicine..

This class of drug therapy turned out to be a big win for patients who have more benefits than glycemic control“

Christopher Cannon, MD, Cardiologist, Brigham and Women’s Hospital

“Originally, the Food and Drug Administration called for an analysis of the safety of these drugs, but studies have shown that SGLT2 inhibitors have beneficial effects, rather than causing harm, and are harmful to cardiovascular and kidney. It has been found to reduce the risk of consequences. “

Type 2 diabetes can lead to hospitalization for heart failure and progression of renal disease, and adult type 2 diabetic patients and their clinicians often have cardiovascular and kidney problems while working to control blood glucose levels. I am dealing with it. Recent studies of other SGLT2 inhibitors have shown that they may benefit both kidney and cardiovascular health.

VERTIS-CV relied on an event-driven non-inferiority structure, but was revised as a result of a prospective study involving another drug in its class.

In light of the positive results of the EMPA-REG study, the VERTIS-CV team doubled the sample size and reduced the remaining time of the study from 5 years to an average of 3 years. Of the 8,238 patients enrolled in the study, the average age was 64.4 years and the average duration of type 2 diabetes diagnosis was 13 years.

Previous studies have established ertugliflozin as an effective drug for controlling blood sugar levels. VERTIS-CV evaluated the cardiovascular safety of the drug.

Among patients with type 2 diabetes and atherosclerosis, ertzgliflozin is inferior to placebo due to a combination of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (an endpoint called MACE). did not. Overall, major cardiovascular adverse events occurred in approximately 12% of patients in both the Ertugliflozin and placebo groups.

A combination of both cardiovascular death and hospitalization for heart failure occurred in approximately 8 percent and 9 percent, respectively, in the ertugliflozin and placebo groups. A secondary endpoint of hospitalization for heart failure was a 30% lower rate for ertzgliflozin.

Ertugliflozin is the fourth drug in this class that has been extensively tested and is non-inferior to placebo. Three other major SGLT2 drug trials testing dapagliflozin, canagliflozin, and empagliflozin have yielded significant benefits across a variety of endpoints.

According to the American Diabetes Association guidelines established in 2019, SGLT2 inhibitors such as ertugliflozin in patients with type 2 diabetes can be used to lower blood glucose levels, and cardiovascular and renal events in patients who are prone to these complications. It is recommended to be used as an additional drug to reduce the risk of. Canon describes the results of his team in support of these guidelines.

“The guidelines are, if anything, a little before their time and are spotted,” Canon said.

“These data reaffirmed the guidelines and now it is up to us as clinicians to adhere to them more fully.”