PHILADELPHIA, Nov 11 (Reuters) – Novo Nordisk ( NOVOb.CO ) said on Saturday that the heart-protective benefits of its wildly popular Wegovy obesity treatment are due to more than weight loss alone, according to new data presented at a major medical meeting on Saturday.
Early data from the Danish drugmaker’s Select trial released 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 attack, stroke or death from heart disease by 20%.
Full results from 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 the drug has other beneficial effects beyond the known health benefits of weight loss . .
The heart risk difference between patients given Wegovy, known chemically as semaglutide, and those given a 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 had pre-existing heart disease but not diabetes, Wegovy reduced the risk of non-fatal heart attack by 28%, non-fatal stroke by 7% and heart-related death by 15% compared with placebo.
Given that the patients hadn’t started losing weight when the cardiovascular benefits first became apparent, that suggests the heart protection wasn’t 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 examine how semaglutide could prevent heart disease from happening, and only looked at how to prevent it from get worse.
Despite this, the size of the patient population included in this trial should make doctors think about which types of patients 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 fits into this study, which is a very large patient population,” he said.
The study researchers said that while understanding the mechanisms of cardiovascular protection from semaglutide remains speculative, there was a consistent effect on associated risk factors, supporting the idea that multiple pathways underlie the drug’s clinical benefit.
The associated risk factors include inflammation, blood pressure and blood sugar control, all of which can affect heart health.
Patients on Wegovy experienced decreases in C-reactive proteins, an indication of inflammation, similar to those reported with cholesterol-lowering statins, which are known to significantly lower heart risk, researchers reported.
“The cardiovascular benefit (of Wegovy) is a combination of many factors, but I would call glycemic (blood sugar) control, weight loss and inflammation,” Martin Lange, Novo Nordisk’s chief development officer, said in an interview.
In the trial of 17,604 patients with an average duration of 33 months, nearly 1,500 of those taking Wegovy discontinued treatment because of unwanted side effects, mostly gastrointestinal disorders such as nausea and vomiting, compared with 718 patients in the placebo group, according to the study .
Although the trial was not conducted to test weight loss, participants lost an average of almost 10% of their total body weight. Novo said patients in the heart study were not required to track diet and exercise as they are in obesity trials.
The study found Wegovy to be safe and well-tolerated, consistent with previous semaglutide trials, Novo said.
It was unclear whether the findings applied to all drugs in the GLP1 class or were specific to semaglutide, Barclays analyst Emily Field said in an interview.
Lange said he expected the company’s application to have Wegovy’s label updated to include the heart benefits to be approved in the United States in the first half of next year and in the European Union in the second half. Drug regulators can 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 had accepted its label update application under priority review, meaning the agency will make a decision within six months.
U.S. and British drug regulators on Wednesday approved Eli Lilly’s ( LLY.N ) rival weight loss treatment, which had previously been approved and marketed as Mounjaro for diabetes.
Reporting by Patrick Wingrove Editing by Caroline Humer, Bill Berkrot and Diane Craft
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