Still life of Wegovy, an injectable prescription weight loss medication that has helped people with obesity. It should be used with a weight loss and physical activity plan.
Michael Siluk | UCG | fake images
Nordisk Wegovy reduced the risk of serious cardiovascular complications in people with obesity and heart disease in a closely watched trial, showing a particularly large effect on heart attacks. a promising new frontier for the drug.
The Select study, which involved about 17,500 people, tested Wegovy in people with obesity and heart disease but who did not have diabetes. Weekly injections of Wegovy reduced the overall risk of heart attack, stroke and death from cardiovascular causes by 20%, according to detailed trial results presented Saturday at the American Heart Association Scientific Sessions and published simultaneously in the New England Journal of Medicine. Novo Nordisk revealed the main data of the study in August.
Findings could expand Wegovy’s insurance coverage, a major barrier so far for the drug and similar GLP-1 agonists, and will spur broader use of the anti-obesity drug.
“This is the first time that a drug approved for the management of chronic obesity can be considered life-saving,” said Dr. Robert Kushner, professor of medicine in endocrinology at Northwestern University Feinberg School of Medicine, who participated in the study.
The new data could also help the Danish pharmaceutical company maintain its lead over Eli Lilly, whose competing weight-loss drug, Zepbound, was approved in the United States earlier this week. Zepbound has been shown to help people lose more weight, but no effect on cardiovascular outcomes has yet been shown.
“If you look at where insurance companies will be forced to go, they will be forced to go with the drug that reduces cardiovascular events,” said Dr. Howard Weintraub, clinical director of the Center for Cardiovascular Disease Prevention at NYU. Langone Heart who participated in the study.
Wegovy reduced the risk of non-fatal heart attack by 28% in the five-year trial. It produced a smaller 7% reduction in the occurrence of non-fatal strokes, although few strokes were seen in the trial overall.
What’s more, Wegovy began showing a reduction in overall cardiovascular events within a few months after participants started taking the drug, and the difference between the drug and placebo widened as the study progressed.
About two-thirds of the participants had blood sugar levels that put them in the prediabetes range. Wegovy slowed progression to diabetes by 73%, suggesting the drug could be used as an early treatment. Novo’s Ozempic, which uses the same active ingredient as Wegovy, is approved for diabetes.
The study enrolled patients whose body mass index met the threshold for overweight or obesity, although most patients were considered obese.
Side effects and limitations.
Nearly 17% of people given Wegovy in the trial stopped taking the drug, mainly due to gastrointestinal problems such as vomiting and diarrhea, double the rate of people who stopped the placebo. But more people in the control group experienced serious adverse events, such as heart disorders and medical procedures.
The discontinuations may reflect less familiarity with Wegovy among doctors involved in the study, said Kushner, who specializes in caring for patients who are overweight or obese. Adjusting the dosage or modifying the diet can help people overcome unpleasant side effects.
Participants also lost less weight in this study than in previous ones that examined Wegovy, although this study did not incorporate lifestyle changes and enrolled people with different characteristics.
A limitation of the study was its lack of diversity. Nearly three-quarters of the participants were men and even more were white. Approximately 4% of the participants were black.
Still, doctors hope the results will increase the number of people taking Wegovy.
Seeing a diabetes drug produce positive cardiovascular and metabolic effects “opens a new door for treating obese patients with cardiovascular disease,” said Dr. George Dangas, director of surgery for the structural heart program at Mount Sinai Health System. But incorporating it into clinical practice could take time and energy.
“It’s good to have those problems,” Dangas said. “We have something good for the patient, that’s great.”
—CNBC’s Patrick Manning contributed to this report.