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Certain blockbuster weight-loss drugs have been found to be significantly heart-protective, and new research suggests that their cardiovascular benefits may extend to a wider range of patients than clinical trial data suggests, helping to prevent tens of thousands of heart attacks and strokes in the United States each year.
Clinical trial data from the pharmaceutical company Novo Nordisk showed that people taking Wegoby had a 20% lower risk of heart attack than those taking a placebo. In March, the Food and Drug Administration approved a label change for Wegoby to add cardiovascular benefits, making Wegoby the first weight-loss drug shown to reduce the risk of heart attack, stroke, or cardiac-related death in people at high risk.
Wegovi belongs to a class of drugs called GLP-1 receptor agonists and its active ingredient, semaglutide, is also approved to treat type 2 diabetes as Ozempic.
Novo Nordisk’s trial was limited to obese patients with a history of heart attack or stroke, or symptoms of peripheral artery disease, such as clogged arteries in the arms or legs.
New research from Dandelion Health, a platform that uses real-world data and clinical AI to advance personalized medicine, finds that GLP-1 drugs may also act as primary prevention, significantly reducing the risk in patients with mild or moderate cardiovascular disease who have not previously had a heart attack.
With the help of artificial intelligence, the researchers analyzed real-life medical records of patients similar to those who participated in Novo Nordisk’s clinical trials, but without a history of significant cardiovascular disease.
The researchers tracked years of medical history, focusing particularly on electrocardiogram readings – measurements of the heart’s electrical activity – and used an AI model to predict what effect GLP-1 would have in reducing the risk of heart attack and stroke, then tested the predictions against actual events.
The researchers found that GLP-1 reduced the risk of heart attack and stroke by 15 to 20 percent, which is consistent with the clinical trial results but in a broader population, potentially benefiting an additional 44 million people.
From these results, the researchers estimate that if everyone in a broad range of potentially eligible patient populations took GLP-1, there could be 34,000 fewer heart attacks and strokes each year.
“Clinical studies focus on moderate to severely ill patients because of the small number of patients needed to prove efficacy. But there’s always a big risk that we’ll miss the drug’s effect on a broader population because we don’t have the time or funding for the studies – this is a natural flaw in clinical research,” said Elliot Green, co-founder and CEO of Dandelion Health.
Broadening the scope of the analysis with the help of AI will help capture patient groups that Dandelion Health researchers consider to be “clinically asymptomatic.”
Experts say GLP-1 drugs have already transformed cardiovascular treatment, and their availability as a primary prevention approach could change the picture even more dramatically.
“I don’t think of these drugs as weight-loss drugs or obesity drugs, but as health enhancers. They improve health,” said Dr. Harlan Krumholtz, a cardiologist and scientist at Yale University and Yale-New Haven Hospital, who was not involved in the analysis.
But for people who are wary of using the drug to treat obesity, more evidence of its benefit to the heart could make a big difference, he said.
“We can reframe the discussion,” Krumholz said, “to move them into a lower-risk category and help them live longer, healthier lives.”
Dr. Brendan Everett, a cardiologist at Brigham and Women’s Hospital and an associate professor at Harvard Medical School, prescribes GLP-1 to some of his patients.
“As a preventive cardiologist, I want people to be healthy, and over the last 20 to 30 years I’ve watched the epidemic of obesity and what’s called cardiometabolic disease ravage the U.S.,” he said. “If you want to provide good care for your patients, you at least need to be thinking about (GLP-1) and know how to use it, so increasingly I’m treating obesity to treat obesity.”
GLP-1 has brought about an “absolute paradigm shift” in the treatment of patients with cardiovascular disease, he said, and expanding its use to patients with mild or moderate disease could be beneficial, as long as the costs and goals of prevention are clearly understood.
An analysis published last month in Health Affairs magazine found that if Medicare covered these weight-loss drugs, it could increase Part D spending by $3 billion, even if they were prescribed to just 5 percent of eligible patients. But preventing heart attacks and strokes could reduce health care costs in other ways: A study last year found that a heart attack costs hospitals about $19,000 on average.
Randomized controlled clinical trials like those conducted by Novo Nordisk are the gold standard for evaluating drug safety and effectiveness, and while AI findings must undergo rigorous review before being used for more formal drug approval, new research highlights some valuable benefits that such efforts can bring.
The Dandelion Health analysis captured a more diverse population than the Novo Nordisk trial, with a more balanced gender mix and nearly three times the proportion of non-white patients.
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The new report also found earlier signs: The AI model found that patients’ cardiovascular risk was reduced within two years of starting GLP-1 use — the Novo Nordisk trial took more than three years to complete.
There is a great opportunity to improve cardiovascular health in the U.S. Heart disease is the leading cause of death in the U.S., with stroke being the fifth.
As GLP-1 drugs continue to grow in popularity, experts say the additional data will help ensure that health care providers can get currently limited supplies to those who need them most.
Dr. Jody Dashey, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School, told CNN in March that she hopes Wegovi’s expanded approval to include a cardiovascular indication will lead to increased insurance coverage, especially since generic weight-loss alternatives can carry cardiac risks. She added that this “may help prioritize use” among people “at highest risk of obesity” — people who also have cardiovascular disease.
CNN’s Meg Tyrrell contributed to this report.
