Novo Nordisk shared new clinical trial data that shows its obesity drug Wegovy (semaglutide) can also reduce the risk of various heart complications, including heart attack, in certain individuals.
Novo presented the results of the study at the American Heart Association (AHA) Scientific Sessions this past weekend in Philadelphia, which were also published in the New England Journal of Medicine.
The results come from Novo’s large-scale, Phase III cardiovascular outcomes study SELECT, which involved over 17,000 people in 41 countries who were overweight or obese and had heart disease. The participants did not have diabetes, which GLP-1 agonists like Wegovy can treat. Importantly, the results showed that the heart benefits were independent of Wegovy’s weight loss effects.
In trial data shared by Novo in August, Wegovy (2.4 mg injection, once weekly) cut the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke or cardiovascular death by 20 percent compared to placebo, results that Novo revealed in August. The latest data confirmed these results and showed Wegovy reduced the risk of non-fatal heart attack by 28 percent and the risk of chronic kidney disease progression and renal death by 22 percent.
However, the results did not suggest that Wegovy specifically reduces the risk of cardiovascular death. Despite this, the researchers said there were “directionally consistent effects” across the study’s secondary measures that included heart failure complications, non-fatal heart attacks and death from any cause.
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Cardiovascular disease is the leading cause of disability and death worldwide, resulting in almost 18 million deaths every year. Despite cardiovascular mortality having decreased over the past 20 years, obesity-related cardiovascular deaths have increased significantly. Obesity leads to cardiovascular morbidity and mortality and is associated with risk factors such as high blood pressure and inflammation, said Novo in a news release announcing the trial results.
The SELECT trial began in 2018 and is Novo’s largest trial to date. Study volunteers were at least 45 years of age with a BMI ≥27 kg/m2 and the mean duration of Wegovy treatment was 33 months, offering a more real-world, long-term perspective.
Heart attack, stroke or cardiovascular death occurred in 6.5 percent of participants on Wegovy compared to eight percent of those given placebo. The difference between the two groups was statistically significant and resulted in an overall calculated 20 percent reduction in these cardiovascular events.
Wegovy decreased the risk of stroke by seven percent, the risk of heart-related death by 15 percent and the risk of death by any cause by 19 percent compared to placebo. Notably, the obesity drug also slashed the risk of developing diabetes by 73 percent.
Since the study enrolled individuals who already had heart disease, the results don’t speak to Wegovy’s effects on cardiovascular outcomes in people without preexisting disease. In addition, Black people and women were underrepresented in the study, a study limitation that could hinder the generalization of the results.
Novo noted that the reduction of MACE was evident soon after treatment with Wegovy was started, which suggests “an effect that is more rapid than what would be expected if the cardiovascular effects were entirely mediated with the effects on body weight reduction.”
Novo filed for a label update in the US and EU this year to include an indication for risk reduction of MACE in adults with a BMI ≥27 kg/m2 and established cardiovascular disease. A decision is expected in 2024. In the US, the Food and Drug Administration (FDA) recently granted priority review for the addition of the SELECT data to the label for Wegovy.
Since its approval, Wegovy has been in high demand, which has led to significant shortages of the obesity drug. Despite the supply constraints, the drug has been bringing in over $1 billion every quarter for Novo.