New details from a closely watched clinical trial of Novo Nordisk’s weight loss drug Wegovy confirmed treatment can also prevent an array of heart complications.
Results from the trial, which involved people who were overweight or obese and already had heart disease, are notable evidence supporting use of Wegovy and drugs like it, collectively known as GLP-1 agonists.
In the study, called SELECT, treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo — a statistically significant difference on that so-called “composite” goal. This topline result was announced by Novo Nordisk in early August.
Full trial data, which are being presented Saturday at the American Heart Association’s meeting in Philadelphia, didn’t show Wegovy reduced the risk of cardiovascular death specifically. The lack of clear benefit on this component of the composite goal could raise questions for physicians as they consider how GLP-1 agonists should be used.
Still, researchers described the data as a landmark. “We are in a new era of treating obesity and cardiometabolic risk,” Amit Khera of the University of Texas Southwestern Medical Center and Tiffany M. Powell‑Wiley of the National Heart, Lung, and Blood Institute wrote in an editorial in The New England Journal of Medicine, where the data were also published Saturday.
With the data, Wegovy “joins the list of established therapies that form the basis of our pharmacologic strategies for reducing the risk of cardiovascular disease,” Khera and Powell-Wiley wrote.
SELECT, which began in 2018, enrolled more than 17,000 people aged 45 and older who were overweight or obese and previously had a heart attack, stroke or symptomatic arterial disease. Participants did not have diabetes, a disease which GLP-1 agonists can also treat.
Half of the participants received Wegovy once weekly, while half got a placebo. They were followed for more than three years on average.
A heart attack, stroke or cardiovascular death occurred in 6.5% of study volunteers on Wegovy, compared to in 8% of those given placebo. The difference between the two groups was statistically significant, marking the study as a success.
However, when researchers examined cardiovascular death alone, the rates between the two study arms were close enough they didn’t definitively prove Wegovy’s benefit on that narrower measure. As a result, the investigators didn’t do formal statistical testing on the remaining components individually, providing only estimates of benefit that “should not be used to infer definitive treatment effects.”
Still, the researchers noted “directionally consistent effects” across the study’s secondary measures, which included heart failure complications, non-fatal heart attacks and death from any cause.
Since the study enrolled people who already had heart disease, the results don’t say anything about whether Wegovy could improve cardiovascular outcomes in people without preexisting disease. Women and Black people were underrepresented in the study as well, possibly limiting the generalizability of the findings.
Serious adverse events occurred less frequently in people taking Wegovy, although more participants on the drug discontinued because of adverse events. Like other GLP-1 drugs, Wegovy can cause gastrointestinal side effects, which was the most common reason people stopped the trial.
Pancreatitis, gallbladder disease and suicidal thoughts are among the potential side effects to Wegovy listed on the drug’s approved labeling for weight loss.
Wegovy is a blockbuster product for Novo already, selling so fast the Danish drugmaker has not been able to keep the medicine in stock. Analysts and industry executives see the GLP-1 drug class earning tens of billions of dollars a year by the end of the decade, with some predicting sales as high as $90 billion.
Currently, Wegovy’s closest competitor is Eli Lilly’s Zepbound, which works similarly and won U.S. approval for weight loss on Nov. 8. But behind Novo and Lilly are a long list of potential rivals, including Pfizer, Amgen, Boehringer Ingelheim and AstraZeneca. Smaller startups are in the mix, too.
Versions of Wegovy and Zepbound are also approved for controlling blood sugar in people with diabetes, for which they’re respectively sold as Ozempic and Mounjaro.
While Ozempic and Mounjaro are generally covered by insurance in the U.S., payers have signaled greater concern with paying for obesity treatment. Wall Street analysts expect that data showing a heart benefit are essential to expand access.
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- Source: https://www.biopharmadive.com/news/detailed-trial-data-confirm-wegovy-heart-benefit/699449/