PThe popular weight loss drug has dominated news headlines and social media, primarily because it helps people lose weight and control diabetes. But now there is evidence that one drug, semaglutide, can also reduce the risk of death from heart disease in some patients. The drug semaglutide is sold under the trade names Wegovy, Ozempic, and Rybelsus. However, this trial only studied the effects of Wegovy, a 2.4 mg semaglutide injection currently approved for weight management. Results of a long-awaited study sponsored by Novo Nordisk, the manufacturer of semaglutide, examining the effects of semaglutide on the heart were presented at the American Heart Association’s annual meeting in Philadelphia. New England Medical Journal.
The study involved more than 17,000 people who did not have diabetes but had a history of heart attack, stroke or cardiovascular conditions, were overweight or obese, and had a body mass index of 27 or higher. They had a history of heart disease and most were taking medications to treat risk factors such as high blood pressure, high cholesterol and blood clots. In addition to controlling for these risk factors, researchers randomly assigned half of the volunteers to receive semaglutide and to learn how losing weight affected their risk of dying from heart disease. A therapeutic drug was administered. overweight and obese, while the other half received a placebo.
After more than three years, scientists led by Dr. A. Michael Linkoff, a professor of medicine at the Cleveland Clinic, found that people who received semaglutide lost about 9% of their weight, compared to found that the weight loss was less than 1%. Placebo group. People who took semaglutide also had a 20% lower risk of having a heart attack, stroke, or dying from a cardiac event compared to people who took a placebo. The results drew applause from a standing-room-only audience packed into one of the main auditoriums at the American Heart Association conference.
“While it is well established that obesity and overweight increase the risk of cardiovascular events, standard treatment includes treating risk factors such as high blood pressure, diabetes, and high cholesterol with drugs; “The risk factors for being overweight have not yet been resolved; they could be effectively treated in the past,” Linkov told TIME. “Some patients now have additional modifiable risk factors that can be treated with another route, namely semaglutide.”
“This is a completely new way to address obesity and its metabolic complications,” said Dr. Amit Khera, director of the Preventive Cardiology Program at the University of Texas Southwestern Medical Center. “The fact that we now have a new treatment option for patients with cardiovascular disease is very exciting and welcome.”
“The results are surprising,” says Dr. Holly Lofton, director of the Medical Weight Management Program at NYU Langone Health, who led the study at one of the more than 800 sites participating in the trial. “I think this will change prescribing practices.”
Dr. Ania Jastreboff, associate professor of medicine at Yale University School of Medicine and director of the Yale Obesity Research Center, said the patients in this study represent a larger population of 6.6 million people in the United States who could potentially benefit from this drug. he said in a lecture. meeting.
Professor Linkoff said that although the trial found a link between weight loss drugs and a lower risk of cardiac events, the effect may be more complex than a simple correlation between weight loss and lower risk. It is pointed out that there is a sex.influence [heart] There are risks,” he says. After about a month of weekly treatment, differences in cardiac events between the two groups began to emerge immediately, but weight loss occurred gradually and did not peak until about a year. “The effects were not necessarily proportional and were not driven by the amount of weight lost,” he explains. In fact, the heart benefits were similar no matter how much people started the study or how much weight they lost during the trial.
Further research is needed to determine exactly how the drug affects the heart, but it is also possible that changes in GLP-1 levels can cause physiological changes that directly affect the heart. “Other studies have shown that excess fat accumulation can directly affect cells in the heart and blood vessels, so the drug can promote inflammation, accelerate atherosclerosis, and make blood stickier. It may be affecting excess fat cells that can increase sex.” [through clotting]All of these things increase the risk of cardiac events,” says Linkoff.
Jastrebov agrees. “We see that if we treat obesity, we can improve hypertension, hyperlipidemia, inflammation, and have an effect on all kinds of diseases,” she said in a conference briefing.
This data provides the strongest reason for doctors to begin treating overweight or obese heart patients in the same way they treat high blood pressure, excess cholesterol, and diabetes in their patients. “It’s always good to have another tool in your toolbox,” says Dr. Sean Heffron, assistant professor of medicine at New York University’s Center for Cardiovascular Disease Prevention. Many heart experts believe that the 20% reduction in cardiac events is in addition to the 20% reduction in cardiac events already experienced with treatment with current standards of care, such as aspirin, cholesterol-lowering statins, and high blood pressure control medications. I am impressed that there has been a decline. “We are literally leaping from the past into the future at a watershed brought about by highly effective obesity drugs,” Jastrebov said.
“We’re thrilled to be working with this new team,” said Dr. Bruno Manno, clinical professor of cardiology at New York University Langone, who was in the audience for the presentation. [treatment]. This result confirms a very convincing argument for their treatment. But he said the drug’s high price (more than $1,000 for a month’s supply), coupled with a lack of coverage by insurance companies and a lack of supply of semaglutide, prevent heart patients from benefiting from the drug. He said this was the biggest barrier. “If it weren’t for the cost and availability issues, we would have no problem treating people for whom this drug is suitable,” he says.
One change that could convince more insurance companies to cover the drug is adding heart benefits to its label. Novo Nordisk asks the U.S. Food and Drug Administration to update the label for semaglutide (Wegovy) to include the fact that the drug can help people lose weight in people with a BMI of 27 or higher and a history of heart disease Did. Risk of further cardiac events. The FDA has granted the application priority review and expects to make a final decision within six months.
Meanwhile, the success of this study means that, of course, people without a history of heart attack or stroke should be given the drug to avoid heart disease in the first place, rather than withholding the drug until heart disease occurs. The question arises whether it should be done or not. events of the heart. “Scientifically, the medical benefits are likely to be similar,” Linkoff says. “But it would be difficult to do that study logically.”
Even if no such studies exist, Dr. Lofton believes that combining the results of this trial with those of previous studies of semaglutide in overweight or obese people without a history of heart disease could help people point out that it may justify using semaglutide to help avoid heart disease. In the first place, there is a heart event. “I think an astute preventive cardiologist or primary care physician would consider that if you are overweight or obese and have a strong family history of heart disease or other risk factors, you are a candidate for semaglutide to help you lose weight.” she says. In fact, the drug is already approved for people who are overweight or obese, but doctors can now tell you that it may not only help you lose weight, but may also reduce your risk of heart disease. However, there is still no solid data to document it. “They may say the drug is not intended to treat cholesterol or blood pressure or other heart risk factors, but they may also see benefit there,” she says. .
Although the data are encouraging, Kela cautioned that the results should be interpreted with caution and do not negate the importance of changing your diet and exercise habits to lower your risk of heart disease. do. He noted that although the study’s subjects were people who already had heart disease, ideally people should avoid experiencing heart disease in the first place. “You don’t want to wait until you develop cardiovascular disease,” he says. “It’s not a choice between lifestyle modification and these drugs. It has become a useful option for
Addressing access and availability will be the next hurdle for semaglutide. Novo Nordisk is ramping up production to meet the already exploding demand for the drug, but supply constraints won’t ease until at least 2024 as new patient populations become eligible for the drug. Probability is high.