Novo Nordisk said Saturday that the heart-protective benefits of its popular obesity treatment Wegovy are due to more than just weight loss, according to new data presented Saturday at a major medical meeting.
Early data from the Danish drugmaker’s Select trial published in August showed that Wegovy, which helps patients lose an average of 15 percent of their weight, also reduced the incidence of heart attacks, stroke or death from heart disease. .
The full study results, presented at the American Heart Association’s annual scientific meeting in Philadelphia before a standing-room-only crowd and published in the New England Journal of Medicine, suggest the drug has other beneficial effects beyond known health benefits of weight loss. .
The difference in heart risk between patients who received Wegovy, known chemically as semaglutide, and those on placebo began to appear almost immediately after starting treatment, the researchers said.
In the study of overweight and obese patients, based on body mass index and with pre-existing heart disease but not diabetes, Wegovy reduced the risk of non-fatal heart attack by 28 percent, d 7 percent non-fatal stroke and cardiac death. 15 percent compared to a placebo.
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Since the patients had not started losing weight when the cardiovascular benefits appeared, this suggests that the cardiac protection was not solely the result of weight loss, Novo said.
Dr. Chad Weldy, a cardiologist at Stanford University, said on the sidelines of the conference that it was important to note that the trial did not study how semaglutide might prevent the onset of heart disease and only examined how to prevent them from getting worse.
Even so, the size of the patient population covered by this trial should prompt doctors to think about the types of patients who should be prescribed Wegovy based on the data.
“Anyone who has had a heart attack or obstructive coronary artery disease and has a body mass index above 27 can participate in this study, which involves a very large patient population,” he said.
Dr. Bruno Halpern, director of the Obesity Center at Hospital 9 de Julho in São Paulo, Brazil, also said at the conference that Wegovy should now be a first-line treatment for heart disease.
Study researchers said that while understanding the cardiovascular protective mechanisms of semaglutide remains speculative, there is a consistent effect on associated risk factors that supports the idea that multiple pathways drive the benefit. drug clinic.
Associated risk factors include inflammation, blood pressure and blood sugar control, all of which can impact heart health.
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John Deanfield, one of the study’s authors and a professor of cardiology at University College London, told the medical meeting that the trial data would spark debate about Wegovy’s place in treatments for doctors.
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“When do we start these medications in our patients? How can we stop them? How much weight do we want them to lose to benefit? he said.
Patients on Wegovy experienced a decrease in C-reactive proteins, an indication of inflammation, similar to those reported with cholesterol-lowering statins, known to significantly reduce heart risks, the researchers reported.
“The cardiovascular benefit (of Wegovy) is a combination of many factors, but I would bring up blood sugar (blood sugar) control, weight loss and inflammation,” said Martin Lange, head of development at Novo Nordisk, in an interview.
In the trial of 17,604 patients lasting an average of 33 months, nearly 1,500 of those taking Wegovy stopped treatment due to unwanted side effects, mainly gastrointestinal upset like nausea and vomiting , compared to 718 patients in the placebo group, according to the study.
Although the trial was not conducted to test weight loss, participants lost on average almost 10% of their total body weight. Novo said patients in the heart study were not required to follow their diet and exercise routine as is the case in obesity trials.
The study showed Wegovy was safe and well-tolerated, consistent with previous semaglutide trials, Novo said.
It was unclear whether the findings could be applied to all drugs in the GLP1 class or whether they were specific to semaglutide, Emily Field, an analyst at Barclays, said in an interview.
Lange said he expected the company’s application to have Wegov
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Y’s label has been updated to include heart benefits that will be approved in the US in the first half of next year and in the EU in the second half. Drug regulators may update information on drug labels to include new data or reflect new indications for use after initial approval.
U.S. and British drug regulators on Wednesday approved Eli Lilly’s rival weight loss treatment, which had already been approved and marketed as Mounjaro for diabetes.
(Reporting by Patrick Wingrove, editing by Caroline Humer, Bill Berkrot and Diane Craft)