Novo Nordisk said Saturday that the heart-protecting benefits of its wildly 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 has been shown to help patients lose an average of 15% of their weight, also reduced the incidence of heart attacks, strokes or deaths from heart disease by 20%.
The full results of the study, presented to a standing-room-only audience at the American Heart Association's annual scientific meeting in Philadelphia and published in the New England Journal of Medicine, suggest that the drug has known health benefits The benefits of losing weight also have other positive effects.
The difference in heart risk between patients who received Wegovy, chemically known as semaglutide, and those who received placebo began to emerge almost immediately after starting treatment, researchers said.
In the study of overweight and obese patients based on body mass index who already had heart disease but not diabetes, Wegovy reduced the risk of a nonfatal heart attack by 28%, a nonfatal stroke by 7%, and of heart-related death by 15 % compared to a placebo.
Given that the patients had not yet started losing weight when the cardiovascular benefits first appeared, this suggests that cardiac protection was not just 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 study did not look at how semaglutide might prevent the onset of heart disease, but simply looked at how to prevent it from happening these worse.
Still, the size of the patient population covered by this study should prompt physicians to consider which patient populations should be prescribed Wegovy based on the data.
“Anyone who has had a heart attack or obstructive coronary disease and has a body mass index greater than 27 is eligible for this study, which is a very large patient population,” he said.
Study said researchers that while understanding of the mechanisms of cardiovascular protection from semaglutide remains speculative, there is a consistent impact on associated risk factors, supporting the notion that there are multiple pathways behind the drug's clinical benefit.
Associated risk factors include inflammation, blood pressure and blood sugar control, all of which can affect heart health.
Patients on Wegovy experienced a decrease in C-reactive proteins, an indication of inflammation, similar to cholesterol-lowering statins known to significantly reduce heart risk, researchers reported.
“The cardiovascular benefit (of Wegovy) is a combination of many factors, but I would highlight glycemic (blood sugar) control, weight loss and inflammation,” Novo Nordisk development director Martin Lange said in an interview.
In the study of 17,604 patients and an average duration of 33 months, nearly 1,500 of those taking Wegovy discontinued treatment due to adverse side effects, mainly gastrointestinal symptoms such as nausea and vomiting, compared with 718 patients in the placebo group, according to the study the study.
Although the study wasn't conducted to test weight loss, participants lost, on average, nearly 10% of their total body weight. Novo said patients in the heart trial were not required to monitor diet and exercise, as is the case in obesity trials.
The study showed that Wegovy was safe and well tolerated, consistent with previous semaglutide studies, Novo said.
It's unclear whether the results apply to all GLP1-class drugs or are specific to semaglutide, Barclays analyst Emily Field said in an interview.
Lange said he expects the company's application for a label update to include heart benefits for Wegovy, which is expected to be approved in the US in the first half of next year and in the EU in the second half. Drug regulators may update the information on drug labels to include new data or reflect new indications for use after initial approval.
Novo Nordisk reported last week that the US Food and Drug Administration accepted its label update application under priority review, meaning the agency will make a decision within six months.
Drug regulators in the United States and Britain on Wednesday approved Eli Lilly's competing weight-loss product, previously approved and marketed as Mounjaro for diabetes.

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