© Reuters. FILE PHOTO: A 0.25 mg injection pen of Novo Nordisk’s weight-loss drug Wegovy is proven on this photograph illustration in Oslo, Norway, September 1, 2023. REUTERS/Victoria Klesty/Illustration/File Photo
By Patrick Wingrove
PHILADELPHIA (Reuters) – Novo Nordisk (NYSE:) on Saturday mentioned the guts protecting advantages of its wildly well-liked Wegovy weight problems remedy are on account of greater than weight reduction alone, in line with new information introduced at a significant medical assembly on Saturday.
Early information from the Danish drugmaker’s Select trial launched in August demonstrated that Wegovy, which has been proven to assist sufferers lose a median of 15% of their weight, additionally lowered incidence of coronary heart assault, stroke or loss of life from coronary heart illness by 20%.
Full outcomes from the examine, introduced on the American Heart Association annual scientific assembly in Philadelphia and revealed within the New England Journal of Medicine, counsel the drug has different helpful results past the identified well being advantages from shedding pounds.
The coronary heart threat distinction between sufferers who acquired Wegovy, identified chemically as semaglutide, and people on placebo started to appear virtually instantly after beginning remedy, researchers mentioned.
In the examine of chubby and overweight sufferers primarily based on physique mass index who had preexisting coronary heart illness however not diabetes, Wegovy lowered the danger of non-fatal coronary heart assault by 28%, non-fatal stroke by 7% and heart-related loss of life by 15% in comparison with a placebo.
Given that sufferers had not began shedding pounds when the cardiovascular advantages first appeared suggests the guts safety was not purely the results of weight reduction, Novo mentioned.
The researchers mentioned that whereas understanding of the mechanisms of the cardiovascular safety from semaglutide stay speculative, there was a constant impact on related threat elements that help the concept a number of pathways are behind the drug’s medical profit.
The related threat elements embody irritation, blood stress and blood sugar management, all of which might affect coronary heart well being.
Patients on Wegovy skilled decreases in C-reactive proteins, a sign of irritation, just like these reported with ldl cholesterol decreasing statins, that are identified to considerably decrease coronary heart dangers, researchers reported.
“The cardiovascular benefit (of Wegovy) is a combination of many factors, but I would call out glycemic (blood sugar) control, weight loss and inflammation,” Martin Lange, Novo Nordisk’s head of growth, mentioned in an interview.
In the 17,604-patient trial with a imply length of 33 months, virtually 1,500 of these taking Wegovy discontinued remedy on account of hostile unwanted effects, largely gastrointestinal issues like nausea and vomiting, in comparison with 718 sufferers within the placebo group, in line with the examine.
Though the trial was not carried out to check weight reduction, members misplaced a median of practically 10% of their whole physique weight. Novo mentioned sufferers within the coronary heart examine weren’t required to trace food regimen and train as they’re in weight problems trials.
The examine confirmed Wegovy to be protected and well-tolerated according to earlier semaglutide trials, Novo mentioned.
Lange mentioned he anticipated the corporate’s utility to have Wegovy’s label up to date to incorporate the guts advantages to be accepted within the U.S. within the first half of subsequent yr and within the EU within the second half. Drug regulators can replace the data on medication labels to incorporate new information or replicate new indications to be used after preliminary approval.
Novo Nordisk reported final week that the U.S. Food and Drug Administration had accepted its label replace utility beneath precedence evaluate, that means the company will resolve inside six months.
U.S. and UK drug regulators accepted Eli Lilly (NYSE:)’s rival weight-loss remedy on Wednesday, which had beforehand been accepted and marketed as Mounjaro for diabetes.