Certain blockbuster weight-loss drugs have been found to protect the heart in significant ways, and new research suggests that the cardiovascular benefits could extend to an even broader set of patients than clinical trial data has shown – helping prevent tens of thousands of heart attacks and strokes each year in the United States.
Clinical trial data from drugmaker Novo Nordisk showed that people using Wegovy had a 20% lower risk of a cardiac event than those who got a placebo. In March, the US Food and Drug Administration approved a change that added cardiovascular benefits to Wegovy’s label, making it the first weight-loss drug to be cleared to reduce the risk of heart attack, stroke or heart-related death in people at higher risk of these conditions.
Wegovy is part of 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 people living with obesity who had a previous 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 care, found that GLP-1 drugs could also serve as primary prevention, significantly reducing risk for people with mild or moderate cardiovascular disease who hadn’t had a cardiac event.
With the help of artificial intelligence, researchers analyzed real-world medical records for a set of patients who were similar to those enrolled in the Novo Nordisk clinical trial but without the history of a major adverse cardiovascular event.
Tracking years of medical history – with a particular focus on electrocardiogram readings, or measures of the heart’s electrical activity – the researchers used an AI model to predict the benefits that GLP-1s could have in reducing the risk of heart attack or stroke and then validated those predictions against actual events.
They found that GLP-1s reduced the risk of heart attack or stroke by 15% to 20%, in line with findings from the clinical trial – but for a broader population, with benefits that could extend to 44 million additional people.
With these results, they also estimate that if everyone in this broader population of potentially eligible patients took GLP-1s, it could result in 34,000 fewer heart attacks and strokes each year.
“In clinical research, you take the moderate to severe patients because you require fewer patients to prove out the efficacy. But there’s this huge danger that you will consistently miss the impact of medication on broader populations because you just can’t afford the time or money to study them. This is just a natural flaw of clinical research,” said Elliott Green, co-founder and chief executive officer of Dandelion Health.
Broadening the scope of analysis – with help from AI – helps capture a group of patients that researchers from Dandelion Health considered “clinically silent.”
Experts say GLP-1 drugs have already transformed cardiovascular care, and the ability to use them as a primary prevention method could dramatically shift the landscape even more.
“I think about these drugs not as weight loss drugs or even drugs for obesity but as health promoters. They improve health,” said Dr. Harlan Krumholz, a cardiologist and scientist at Yale University and Yale New Haven Hospital who was not involved in the new analysis.
But for people who are unsure about using the medications to treat obesity, extra evidence of the benefits they have for the heart could make all the difference, he said.
“We could reframe the discussion,” Krumholz said. “It’s about trying to get them in a lower-risk category and helping them live a longer and healthier life.”
Dr. Brendan Everett, a cardiologist at Brigham and Women’s Hospital and associate professor at Harvard Medical School, has prescribed GLP-1s for some of his patients.
“I am a preventive cardiologist who wants people to be well and has watched this epidemic of obesity and what we call cardiometabolic disease consume the United States over the past two or three decades,” he said. “If you want to deliver good care to your patients, you have to at least think about [GLP-1s] and know how to use them. So increasingly, I am treating obesity for the sake of treating obesity.”
GLP-1s have created an “absolute paradigm shift” in caring for people with cardiovascular disease, he said. Expanding use to those with mild or moderate disease could be beneficial, as long as the costs and goals for prevention are clearly understood.
An analysis published last month in the Health Affairs journal suggests that Medicare coverage of these weight-loss drugs could increase Part D spending by $3 billion, even if just 5% of eligible patients were prescribed one. But preventing heart attacks and strokes can reduce health care spending in other ways; research from last year found that heart attacks cost hospitals an average of about $19,000.
Clinical trials with randomized controls, such as the one conducted by Novo Nordisk, are the gold standard for assessing medication safety and efficacy. AI-driven findings are subject to greater scrutiny before they can be used in a more formal drug approvals, but the new research highlights some valuable benefits that work like this can provide.
The analysis by Dandelion Health captured a more diverse population than the Novo Nordisk trial did, including a more balanced ratio of men and women and nearly three times larger share of patients who were not White.
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The new report also found a signal faster: The AI model identified decreased cardiovascular risk in patients in less than two years after they started using GLP-1s; the Novo Nordisk trial took more than three years to complete.
Opportunities to improve cardiovascular health in the US are significant. Heart disease is the leading cause of death in the US, and stroke is fifth.
And as GLP-1 drugs continue to soar in popularity, experts say that additional data could help health care providers better ensure that the currently limited supply is getting to those who need it most.
