Long-awaited findings from an international study of more than 17,000 patients showed the weight loss drug Wegovy reduced the risk of having a heart attack or stroke, and the risk of dying from a heart attack.
The multi-center study was led by A. Michael Lincoff, MD, the vice chair for research in Cleveland Clinic's Department of Cardiovascular Medicine, and was presented at the American Heart Association's annual meeting Nov. 11. The three-year trial ran from October 2018 through June 2023 and enrolled 17,000 patients worldwide who had no history of diabetes, but had a history of heart attack, stroke or peripheral artery disease. Participants were 45 and older and had a body mass index of 27 or greater.
Participants were randomly assigned to receive weekly injections of Wegovy (2.4 milligrams of semaglutide) or a placebo and were followed for 40 months. Patients who received semaglutide lost about 9% of their body weight on average over the course of the study, relative to 1% in the placebo group. Those who received semaglutide were also about 20% less likely to have a heart attack or stroke, or die from a heart attack, compared to those who received a placebo.
"While reducing cardiovascular disease by treating high cholesterol, high blood pressure, and diabetes is standard practice, the concept of treating obesity to reduce cardiovascular complications has been hampered by the lack of evidence that lifestyle or pharmacologic interventions for overweight or obesity improve cardiovascular outcomes," Dr. Lincoff said in a news release. "This marks the first pharmacologic intervention for overweight or obesity that's been shown in a rigorous fashion to reduce the risk of cardiovascular events."
Weight loss occurred gradually over the study period, though the heart benefits were similar for participants no matter how much they weighed at the start or how much they lost, Dr. Lincoff told Time, adding future research is needed to determine how the drug affects the heart.
About 800 centers were involved in the trial, which was sponsored by Wegovy's maker, Novo Nordisk. Dr. Lincoff received consulting fees from the company, according to a disclosure noted in a news release.
According to Time, experts in the audience at the AHA's conference were largely optimistic about the benefit the drug could offer cardiac patients.
"The results are astounding," Holly Lofton, MD, director of the medical weight management program at NYU Langone Health, who led one of the study's trial centers, said at the conference when findings were presented, according to Time. "I think this will change prescribing practices."
High costs and lack of insurance coverage were key concerns, however. Other studies have linked GLP-1 agonists to stomach paralysis and other serious GI side effects.
Recent survey findings indicate 43% of employers plan to cover weight loss drugs in 2024, nearly double the proportion of employers that cover them now. Meanwhile, Novo Nordisk has filed a request with the FDA to update the label for Wegovy to mention a reduced risk of heart events among people with a BMI of 27 or higher and with a history of heart disease, which it anticipates will convince more insurers to cover the drug.