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FEATURED CONTENT
Findings from a new large-scale clinical trial of Novo Nordisk's weight-loss drug Wegovy suggest that it may reduce the risk of serious cardiovascular events by 20%. Advisory Board's Regina Lohr and Gabriela Marmolejos share their three biggest takeaways from the trial and explain how these findings could impact chronic disease prevention.
Wegovy may reduce the risk of serious cardiovascular events by 20%
In a new large-scale clinical trial, Novo Nordisk's weight-loss drug Wegovy reduced the risk of serious cardiovascular events, such as heart attack and stroke, by 20%.
In the late-stage SELECT trial, researchers analyzed data from 17,604 participants ages 45 and older who either received a 2.4-milligram dose of Wegovy or a placebo as well as standard care.
Participants were either overweight or obese and had existing cardiovascular disease, but not prior history of diabetes. Overall, the researchers found that Wegovy reduced the risk of heart attacks, strokes, and cardiovascular deaths by 20%, surpassing the study's initial goal of a 17% reduction in risk.
"Twenty percent is huge," said Shauna Levy, an obesity medicine specialist and medical director of the Tulane Bariatric Center. "All of this narrative about people just wanting this for cosmetic reasons, I think, to some degree, has overshadowed all of the health benefits we can get from this medication."
"People are very excited," said James Januzzi, a cardiologist and researcher at Massachusetts General Hospital, who was not involved in the study. "Although we have been able to slow the tide of heart disease in the last 20 years, a lot of those gains have started to be lost because of the rise of obesity and diabetes."
Levy noted that the results of the study may be compelling enough to convince insurers to cover the treatment, something many have been reluctant to do due to high costs. Currently, Novo Nordisk and other companies developing weight-loss drugs are testing whether these drugs can treat other health conditions, such as sleep apnea, liver disease, and chronic kidney disease.
According to Joseph Wu, the president of the American Heart Association and a cardiologist at the Stanford University School of Medicine, "it is likely that by reducing weight, these comorbid disease conditions will also improve." (Lovelace Jr., NBC News, 8/8; Mueller, New York Times, 8/8; Loftus, Wall Street Journal, 8/8; Lenharo, Nature, 8/10; Landman, Vox, 8/9)
3 key takeaways from the latest Wegovy trial
By Regina Lohr and Gabriela Marmolejos
These results reveal the potential of second-generation weight management medications to reduce the risk of chronic diseases. Here are our three biggest takeaways:
1. These findings aren't surprising
Earlier studies have already shown that semaglutide offers cardiovascular risk reduction benefits, including declines in blood pressure, total cholesterol, and triglycerides.
Novo Nordisk's other GLP-1 agonist medication, Victoza (liraglutide), is also already FDA-approved for cardiovascular risk reduction as it demonstrated a 13% major adverse cardiovascular events (MACE) risk reduction compared to placebo in the LEADER trial among adults with type 2 diabetes. However, the SELECT trial demonstrated these benefits among patients without diabetes.
2. We need more details on the trial's design
More details are needed on the SELECT trial's design to better understand how Wegovy's cardiovascular risk reduction compares to other approaches like bariatric surgery, which is known to significantly reduce the risk of MACE. One key factor will be the trial's inclusion criteria and discontinuation rates. We don't yet know if patients who discontinued the medication across the course of the trial were included in the trial data or if the data only included patients who stayed on the medication across the full trial.
In the real world, discontinuation is likely to be a key challenge in achieving these kinds of outcomes with weight loss drugs. Our research found that there are many reasons why patients may not maintain adherence to second-generation medications, such as prohibitive costs and unpleasant side effects.
Tune in to our upcoming diabetes and obesity market trends presentation, where we'll discuss these factors in more detail.
3. These results could pave the way for better reimbursement for second-generation medications
Novo Nordisk's announcement states that it is planning to pursue an expanded FDA indication for Wegovy, as they did with Victoza. This move wouldn't necessarily expand the number of people eligible to receive the medication, as the trial was among people who would, in most cases, already be eligible to use Wegovy for chronic weight management under the existing FDA indication. Still, this could change the perception of Wegovy as a "vanity drug" among payers.
Wegovy and other weight loss medications are not currently eligible for reimbursement from traditional Medicare. This expanded indication could enable traditional Medicare coverage of Wegovy among overweight or obese adults with established cardiovascular disease. And if CMS begins to cover Wegovy under traditional Medicare, other payers will likely follow suit.
Posted on August 16, 2023
Updated on August 16, 2023
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