A pivotal new study suggests that the weight-loss drug Wegovy reduces the risk of heart attack, stroke or death from cardiovascular problems by 20 percent among overweight or obese people with heart disease, a surprising benefit that could change the standard of care for these patients.
“We just identified a new best practice,” said Dr. Clyde Yancy, chief of the division of cardiology at Northwestern Medicine, who was not involved in the study. But the research also raises questions about how exactly the drug helps the heart (through weight loss or other mechanisms) and whether it can be as effective in a real-world setting, with a more diverse group of patients than those included in the study. rehearsal.
Still, the study results, presented Saturday in a standing session at an American Heart Association meeting in Philadelphia, are a turning point for the sought-after new class of obesity and diabetes drugs that also includes Ozempic. and the recently approved Zepbound. Pharmaceutical companies see potential for drugs that goes far beyond obesity. Demonstrating that the drugs not only treat diabetes and help patients lose weight, but can also reduce the risk of other serious obesity-related diseases, could further drive demand and put pressure on insurance companies to make the drugs cover on a broader scale.
The research is “one of the most anticipated trials in the past 10 years,” said Dr. Yuan Lu, an assistant professor of cardiovascular medicine at Yale School of Medicine who was not involved in the study. Aside from statins, he said, no medication has so dramatically reduced cardiovascular risk among people with heart disease. “Use of this drug will skyrocket in the coming years,” he said.
Novo Nordisk, the company that makes Wegovy and Ozempic and which funded the study, said it has already filed paperwork with the Food and Drug Administration and European Union regulators to update Wegovy’s label to include that it may reduce the risk of cardiovascular events in certain patients. Dr. Martin Lange, the company’s executive vice president of development, said he was “very confident” the FDA will approve the new indication.
The study is the largest and longest trial yet of semaglutide, the compound in Ozempic and Wegovy; It is also the largest clinical trial Novo Nordisk has ever conducted. It followed more than 17,000 adults aged 45 and older for up to five years. The vast majority were white and more than two-thirds were men. Most participants in the trial were already taking statins, which are widely recommended for people at risk of cardiovascular disease or stroke. The study excluded people with diabetes; Ozempic is already approved to reduce the risk of heart attack, death or stroke in adults with type 2 diabetes and heart disease.
Among those given a weekly injection of placebo, 8 percent had a heart attack, stroke or died from a cardiovascular event, compared with 6.5 percent of participants taking Wegovy, which is a weekly injection.
These results show that Wegovy could prevent some of the most serious cardiovascular problems among people at high risk. “It’s a big win for the field,” said Dr. Ildiko Lingvay, an endocrinologist at UT Southwestern Medical Center and an author of the study, which was published in The New England Journal of Medicine.
The weight patients lose taking Wegovy could explain some of these differences, said Dr. Michael Lincoff, vice president of research in the department of cardiovascular medicine at the Cleveland Clinic and senior author of the study. But he and other researchers believe that can’t explain the full range of cardiovascular benefits. Participants taking Wegovy had lower blood pressure and better blood sugar control, and showed signs of less inflammation, which could reduce the risk of cardiovascular disease.
Researchers will follow participants to see if the cardiovascular benefits last even when people stop taking the drug. Wegovy is widely considered a lifelong weight loss medication: if people stop taking it, they tend to regain weight.
But because semaglutide is relatively new, “we don’t know as much as we’d like to know about the truly long-term effects,” Dr. Yancy said.
More than 16 percent of Wegovy participants dropped out of the trial due to side effects or other problems, compared with about 8 percent of the placebo group. People who took Wegovy also more likely to experience gastrointestinal problems.
“We have to be careful with the administration of these agents and we have to follow patients carefully,” Dr. Yancy said.
A previous trial showed that Wegovy helped reduce heart failure symptoms in people with obesity and a heart condition known as preserved ejection fraction. And Novo Nordisk is also examining other uses for semaglutide, including as a treatment for kidney disease.
The new findings will increase pressure on more insurance companies to cover Wegovy and could put pressure on Medicare to cover it, said Dr. Scott Hagan, an assistant professor of medicine at the University of Washington who studies obesity. The additional demand for the trial results could make Wegovy, which is already in short supply, even harder to find, said Lindsay Allen, a health economist at Northwestern Medicine. Wegovy’s list price, which exceeds $1,300 a month without insurance, has also made it difficult for some patients to access.
Dr. Allen said the study could have another critical result: pushing the medical field and the general public to view Wegovy and Ozempic not just as vanity drugs, but as treatments for chronic diseases.
“This clearly indicates a change in the way we think about these weight loss drugs,” Dr. Allen said.