CLEVELAND — The American Heart Association is holding its Scientific Sessions meeting in Philadelphia today.
The first study is being presented by Cleveland Clinic cardiologist, Michael Lincoff, MD, and it's big news, but may not be a big surprise.
Results from the “SELECT – Semaglutide and Cardiovascular Outcomes in Patients with Overweight or Obesity Who Do Not Have Diabetes” trial were presented today during a late-breaking science session at the American Heart Association’s Scientific Sessions 2023 and simultaneously published in the New England Journal of Medicine.
In the SELECT trial, which ran from Oct. 2018 through June 2023, researchers enrolled patients 45 years of age or older who had preexisting cardiovascular disease and a body-mass index of 27 or greater but no history of diabetes.
Over 17,000 patients in 41 countries who had previously experienced a heart attack, stroke, and/or had peripheral artery disease were enrolled and followed for an average of 40 months. They were randomly assigned to receive once-weekly injections of semaglutide 2.4 mg or placebo.
Semaglutide is the main ingredient in Wegovy, which is FDA-approved for weight loss, and Ozempic which is being used off label, but is mainly meant for those with Type 2 diabetes,
The study found those using the drug lost 9.4% of their body weight and experienced improvements in a number of other risk factors for cardiovascular disease, compared to those who received a placebo.
But, they also found semaglutide reduced cardiovascular events by 20%.
"We hope and anticipate that the FDA, on the basis of this data, will expand that indication for cardiovascular protection, just as they did for diabetes with this drug. If that's the case, then this takes on a new urgency and it becomes more of a standard of care for this group of patients," said Michael Lincoff, M.D., SELECT’s lead author and vice chair for research in Cleveland Clinic’s Department of Cardiovascular Medicine.
While the weight loss effects of semaglutide appear to occur primarily through appetite suppression, they found the drug has other actions which may reduce cardiovascular risk, including improvements in glucose levels, decreases in blood pressure and cholesterol levels and reductions in inflammation, and beneficial effects on heart muscle and blood vessels.
That's on top of whether the patients were already taking medications for the other conditions.
However, these medications are often priced out of reach for those who simply want to use them for weight loss, often costing more than $1,000 per month. They're also not covered by most insurance for weight loss either.
Dr. Lincoff hopes these findings change the way the drug is prescribed and for whom.
More than half the world population is projected to have overweight or obesity in the next decade. High body-mass index (BMI) is estimated to have accounted for 4 million deaths globally in 2015, more than two thirds of which were caused by cardiovascular diseases
The trial was sponsored by Novo Nordisk, the company that developed semaglutide and makes both Wegovy and Ozempic. Dr. Lincoff has received consulting fees from Novo Nordisk.
The full study can be read below:
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