2023-11-11 13:30:07
par Patrick Wingrove
Novo Nordisk NOVOb.CO said on Saturday that the heart-protective benefits of its popular Wegovy obesity treatment are not due to weight loss alone, according to new data presented at a major meeting medical Saturday.
Initial data from the Danish manufacturer’s Select study, published in August, showed that Wegovy, which helps patients lose an average of 15% of their weight, also reduces the incidence of heart attacks, strokes by 20% brain damage and deaths from heart disease.
The full results of the study, presented 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 additional beneficial effects beyond the known benefits of weight loss. weight for health.
The difference in heart risk between patients who received Wegovy, known by the chemical name semaglutide, and those who received a placebo appeared almost immediately following starting treatment, the researchers said.
In the study of patients who were overweight or obese by body mass index and had pre-existing heart disease but not diabetes, Wegovy reduced the risk of non-fatal heart attack by 28%, stroke non-fatal brain injury by 7% and cardiac death by 15% compared to a placebo.
The fact that patients had not started losing weight when the cardiovascular benefits first appeared suggests that the protection of the heart was not solely the result of weight loss, Novo said.
The researchers said that while understanding the mechanisms of cardiovascular protection by semaglutide remains speculative, there was a consistent effect on associated risk factors that supports the idea that multiple pathways drive the clinical benefit of the drug. medicine.
Associated risk factors include inflammation, blood pressure, and blood sugar control, all of which can impact heart health.
Patients on Wegovy experienced a decrease in C-reactive protein, an indication of inflammation, similar to that seen with cholesterol-lowering statins, which are known to significantly reduce heart risks, the researchers reported. ) “The cardiovascular benefit (of Wegovy) is a combination of many factors, but I would cite blood sugar control (, weight loss and inflammation), said Martin Lange, head of development at Novo Nordisk, during ‘an interview.
According to the study, in the trial of 17,604 patients with an average duration of 33 months, almost 1,500 patients taking Wegovy discontinued treatment due to unwanted side effects, mainly disorders gastrointestinal symptoms such as nausea and vomiting, compared to 718 patients in the placebo group.
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, as is the case in obesity trials.
The study showed Wegovy was safe and well-tolerated, consistent with previous semaglutide trials, Novo said.
Mr. Lange said he expected the application to update Wegovy’s label to include heart benefits to be approved in the United States in the first half of next year and in the European Union during the second half of the year. Drug regulators may update information on drug labels to include new data or reflect new indications for use following initial approval.
Novo Nordisk said last week that the U.S. Food and Drug Administration had accepted its request to update the label under priority review, meaning the agency will make a decision within six months.
U.S. and British authorities on Wednesday approved Eli Lilly’s competing weight-loss treatment LLY.N , , which had already been approved and marketed under the name Mounjaro for diabetes.
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