A pivotal new study suggests that the weight loss drug Wegovy cut the risk of heart attack, stroke or death from cardiovascular issues by 20 percent among overweight or obese people with heart disease — a striking benefit that could change the standard of care for these patients.
“We’ve just identified a new best practice,” said Dr. Clyde Yancy, chief of the division of cardiology at Northwestern Medicine, who was not involved with the study. But the research also raises questions about exactly how the drug helps the heart — through weight loss itself, 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 trial.
Still, the results of the study, presented Saturday in a standing-room only 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 newly approved Zepbound. Drug companies see potential for the medicines that extends far beyond obesity. Proving that the drugs not only treat diabetes and help patients lose weight, but also can lower the risk of other serious diseases linked with obesity, could further drive demand — and pressure insurance companies to cover them at a broader scale.
The research is “one of the most anticipated trials in the last 10 years,” said Dr. Yuan Lu, an assistant professor of cardiovascular medicine at the Yale School of Medicine who was not involved in the study. Outside of statins, she said, no medication has so dramatically reduced cardiovascular risk among people with heart disease. “The uptake of this drug is going to be skyrocketing in the next couple of years,” she 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 regulators in the European Union to update Wegovy’s label to include that it can 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 F.D.A. will approve the new indication.
The study is the longest and largest trial yet of semaglutide, the compound in Ozempic and Wegovy; it is also the biggest clinical trial Novo Nordisk has ever conducted. It followed more than 17,000 adults 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 lower the risk of heart attack, death or stroke in adults with type 2 diabetes and heart disease.
Among those who received a weekly placebo shot, 8 percent had a heart attack, stroke or died from a cardiovascular event, compared to 6.5 percent of participants who took Wegovy, which is a weekly injection.
These results show that Wegovy might prevent some of the most serious cardiovascular issues among people at high risk. “It’s a huge win for the field,” said Dr. Idiko Lingvay, an endocrinologist at UT Southwestern Medical Center and an author on the study, which was published in The New England Journal of Medicine.
The weight that patients lose taking Wegovy might explain some of these differences, said Dr. Michael Lincoff, vice chair for research in Cleveland Clinic’s department of cardiovascular medicine and the lead author on the study. But he and other researchers believe that can’t account for the full range of cardiovascular benefits. Participants who took Wegovy had lower blood pressure and better blood sugar control, and showed signs of lower inflammation, which all could lower the risk of cardiovascular disease.
Researchers will follow the participants to see if the cardiovascular benefits last even when people stop taking the drug. Wegovy is widely considered a lifelong medication for weight loss: If people stop taking it, they tend to regain weight.
But because semaglutide is relatively new, “we don’t know as much as we would like to know about the truly long-term effects,” Dr. Yancy said.
More than 16 percent of participants on Wegovy dropped out of the trial because of side effects or other issues, compared to around 8 percent of the placebo group. People taking Wegovy were also more likely to experience gastrointestinal problems.
“We have to be thoughtful about the administration of these agents, and we have to follow patients carefully,” Dr. Yancy said.
A previous trial showed that Wegovy helped reduce symptoms of heart failure 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…