International Study of More Than 8,000 People Showed Ertugliflozin Does Not Increase Risk of Cardiac Events

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International Study of More Than 8,000 People Showed Ertugliflozin Does Not Increase Risk of Cardiac Events

VERTIS-CV trial of SGLT2 inhibitor evaluated medication’s cardiovascular safety in patients with type 2 diabetes and heart disease

The sodium glucose co-transporter 2 (SGLT2) inhibitor ertugliflozin does not impact the likelihood of heart attack, stroke, or cardiac death in patients with type 2 diabetes (T2D) and established cardiovascular (CV) disease, according to data presented today. Research also showed the rate of hospitalization for heart failure was lower among study participants treated with ertugliflozin. The study was highlighted during the “Results of the eValuation of ERTugliflozin EffIcacy and Safety CardioVascular Outcomes Trial (VERTIS-CV)” symposium at the American Diabetes Association’s (ADA’s) 80th Virtual Scientific Sessions.

Ertugliflozin, a relatively new member of the SGLT2 inhibitor class of medications, is prescribed as an adjunct medication to diet and exercise to improve glycemic control in adults with T2D. The VERTIS CV Study was an international phase 3, randomized, parallel-group study to determine the CV safety of ertugliflozin compared to placebo. Beginning in 2013, the study enrolled 8,246 participants with T2D throughout the U.S. and 34 countries worldwide who were aged 40 and older and had a documented history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems. The patients were randomly assigned to take either ertugliflozin 15 mg (n= 2747), ertugliflozin 5 mg (n=2752), or a placebo (n= 2747), once daily. Participants were followed for up to 6.1 years to assess the time to the first occurrence of major adverse CV events, including CV death, non-fatal myocardial infarction, or non-fatal stroke (the primary outcome of the study).  

Results of the study indicated: 

  • Patients treated with ertugliflozin had similar rates of CV death, heart attack, or stroke as the placebo group: the primary outcome occurred in 653 of 5,493 (11.9%) patients in the ertugliflozin groups and 327 of 2,745 (11.9%) in the placebo group (p<0.001 for non-inferiority). 
  • Although ertugliflozin was not shown to decrease overall risk of CV death/hospitalization for heart failure nor CV death alone, the rate of hospitalization for heart failure was lower among participants treated with ertugliflozin.
  • The safety profile of ertugliflozin was consistent with known risks of the class of SGLT2 inhibitors; the rates of amputations were 0.6 and 0.5 per 100 patient years, and the confidence limit of this difference included 1.

“While we hypothesized that we would have shown more significant preventive cardiovascular benefits, the overall pattern of benefit is consistent with what has been seen with other drugs in this class,” said Christopher Cannon, MD, lead VERTIS-CV researcher, 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 . “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.” 

Research presentation details:

For more information or to request an interview with Dr. Cannon, please contact Daisy Diaz by phone at (703) 253-4807 or by email at SciSessionsPress@diabetes.org.
 

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About the ADA’s Scientific Sessions
The ADA’s 80th Scientific Sessions, the world’s largest scientific meeting focused on diabetes research, prevention and care, will be held virtually June 12-16, 2020. Leading physicians, scientists and health care professionals from around the world will unveil cutting-edge research, treatment recommendations and advances toward a cure for diabetes. Though the conference will be remote this year, attendees will receive exclusive access to nearly 2,000 original research presentations and take part in provocative and engaging exchanges with leading diabetes experts. Learn more and register at scientificsessions.diabetes.org and join the Scientific Sessions conversation on social media using #ADA2020 and #ADAGoesVirtual.

About the American Diabetes Association
Every day more than 4,000 people are newly diagnosed with diabetes in America. More than 122 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).