© Reuters. FILE PHOTO: In this photo illustration a 0.25 mg injectable pen of the weight loss drug Wegovy from Novo Nordisk is shown in Oslo, Norway, September 1, 2023. REUTERS/Victoria Klesty/Illustration/File Photo
By Patrick Wingrove
PHILADELPHIA (Reuters) – Novo Nordisk said on Saturday that the heart-protective benefits of its popular obesity treatment Wegovy stem from more than just weight loss, according to new data presented at a major medical meeting on Saturday.
Early data from the Danish manufacturer’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 death from heart disease in 20%.
The full results of the study, presented at the American Heart Association’s annual scientific meeting in Philadelphia in front of a standing-room only crowd and published in the New England Journal of Medicine, suggest that the drug has other beneficial effects beyond the Known health benefits of weight loss. .
The difference in heart risk between patients who received Wegovy, known chemically as semaglutide, and those who received placebo began to appear almost immediately after starting treatment, the researchers said.
In the body mass index-based study of overweight and obese patients who had preexisting heart disease but not diabetes, Wegovy reduced the risk of nonfatal heart attack by 28%, nonfatal stroke by 7%, and related death. with the heart by 15%. % compared to a placebo.
Since patients had not started losing weight when cardiovascular benefits first appeared, it suggests that heart protection was not purely a 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 could stop heart disease from occurring and only looked at how to prevent it from getting worse.
Despite that, the size of the patient population covered by this trial should make doctors 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 greater than 27 fits into this study, which is a very large patient population,” he said.
Study investigators said that while understanding semaglutide’s cardiovascular protective mechanisms remains speculative, there was a consistent effect on associated risk factors supporting the idea 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 taking Wegovy experienced decreases in C-reactive proteins, an indication of inflammation, similar to those reported with cholesterol-lowering statins, which are known to significantly reduce cardiac risks, the 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,” said Martin Lange, head of development at Novo Nordisk. (NYSE:). an interview.
According to the study, in the trial of 17,604 patients with a median duration of 33 months, almost 1,500 of those taking Wegovy discontinued treatment due to adverse side effects, mainly gastrointestinal disorders such as nausea and vomiting, compared with 718 patients in the group placebo.
Although the trial was not conducted to evaluate 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 in the obesity trials.
The study showed that Wegovy is safe and well tolerated, in line with previous trials with semaglutide, Novo said.
It was unclear whether the results could apply to all GLP1 class drugs or were specific to semaglutide, Barclays analyst Emily Field said in an interview.
Lange said he expected the company’s application to update Wegovy’s label to include heart benefits would 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.
Novo Nordisk reported last week that the U.S. Food and Drug Administration had accepted its label update request under priority review, meaning the agency will decide within six months.
US and UK drug regulators on Wednesday approved Eli Lilly’s (NYSE:) rival weight loss treatment, which had previously been approved and marketed as Mounjaro for diabetes.
