A 0.25 mg injection pen for Novo Nordisk’s weight loss drug Wigoby is shown in this photo illustration taken on September 1, 2023 in Oslo, Norway.Reuters/Victoria Klesty/Illustration/File photo Obtaining license rights
PHILADELPHIA, Nov. 11 (Reuters) – Novo Nordisk (NOVOb.CO) said on Saturday that the cardioprotective effects of its wildly popular Wegoby obesity drug may reduce weight loss, according to new data presented at a major medical conference on Saturday. He said that it was not only due to this. .
Initial data from the Danish drugmaker Select trial, published in August, showed that Wegovy helped patients lose an average of 15% of their body weight, reducing the incidence of heart attack, stroke, or death from heart disease. It was also demonstrated that it reduced the amount of water by 20%.
The full results of the study were presented in front of a standing-room-only crowd at the American Heart Association’s annual scientific meeting in Philadelphia and published in the New England Journal of Medicine. suggests that there are other beneficial effects beyond the known health benefits of losing weight.
Researchers say the difference in heart risk between patients who received Wigovy, chemically known as semaglutide, and those who received a placebo began to emerge soon after treatment began.
In a study of overweight and obese patients based on BMI with pre-existing heart disease but no diabetes, Wegovy lowered the risk of non-fatal heart attack by 28%, non-fatal stroke by 7%, and heart-related death by 15%. % decreased. % compared to placebo.
Given that patients had not started losing weight when the cardiovascular effects first appeared, Novo said this suggests that the heart protection was not purely a result of weight loss. Ta.
Dr. Chad Weldy, a cardiologist at Stanford University, said on the sidelines of the conference that the trial did not study how semaglutide stopped heart disease from developing, only how it stopped heart disease from worsening. He said it is important to note that the government is considering the following:
Nevertheless, given the size of the patient population in this study, physicians should consider which patients to prescribe Wegovy based on the data.
“Anyone who has had a heart attack or obstructive coronary artery disease and has a BMI over 27 is eligible for this study. The number of patients is very large,” he said.
The researchers concluded that although understanding the mechanism of cardiovascular protection by semaglutide remains speculative, associated risk factors have consistent effects and multiple pathways may be behind the drug’s clinical benefits. He said that this supports the idea that there is.
Associated risk factors include inflammation, blood pressure, and blood sugar control, all of which can affect heart health.
Wegovy’s patients experienced a decrease in C-reactive protein, a sign of inflammation, similar to that reported with cholesterol-lowering statins, which are known to significantly reduce heart risk, researchers said. reported.
Martin Lange, head of development at Novo Nordisk, said in an interview: “The cardiovascular effects[of Wigovy]are a combination of many factors, but I would like to mention glycemic (blood sugar) control, weight loss, and inflammation. I think so,” he said.
According to the study, in a study of 17,604 patients with an average duration of 33 months, approximately 1,500 patients taking Wegovy experienced adverse side effects, primarily nausea, compared to 718 patients in the placebo group. Treatment was discontinued due to gastrointestinal disorders such as vomiting and vomiting.
Although this study was not conducted to test weight loss, participants lost, on average, nearly 10% of their total body weight. Novo said patients in the heart study won’t have to track their diet or exercise like they would in an obesity trial.
The study showed Wegovy to be safe and well-tolerated, consistent with previous semaglutide trials, Novo said.
Barclays analyst Emily Field said in an interview that it is unclear whether the results apply to all GLP1 class drugs or are specific to semaglutide.
Lange said he expects the company’s application will result in an updated label for Wegovy to include heart benefits, which will be approved in the U.S. in the first half of next year and in the European Union in the second half of next year. Drug regulatory authorities can update drug label information to add 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 renewal application under priority review, meaning the Food and Drug Administration will make a decision within six months.
U.S. and British drug regulators on Wednesday approved competing weight loss treatments from Eli Lilly (LLY.N). This treatment was previously approved and sold as the diabetes drug Munjaro.
Reporting by Patrick Wingrove Editing by Caroline Huemer, Bill Berkrot and Diane Craft
Our standards: Thomson Reuters Trust Principles.
