Wegovy shown to reduce risk of heart attack, stroke in major cardiovascular trial

August 11, 2023  Source: drugdu 141

By Meg Tirrell, CNN

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The weight loss drug Wegovy was shown to reduce the risk of heart attack, stroke or heart-related death by 20% in what’s being called a landmark clinical trial in people with cardiovascular disease, the first to show a weight loss drug alone can have such protective effects.
Novo Nordisk studied Wegovy against placebo in addition to standard of care for prevention of major adverse cardiac events in 17,604 adults with heart disease and obesity or who were overweight, but who didn’t have diabetes. It called the five-year trial “Select.”
The finding of a 20% reduction in heart risk is higher than many experts had anticipated. A similar trial for the type 2 diabetes drug Ozempic, which uses the same ingredient, semaglutide, previously showed it could reduce cardiovascular risk by 26% — but no trial had yet shown a risk reduction in people without diabetes.
“Historically, trials of drugs for weight loss have been very unsuccessful, and some of them have shown harm,” Cleveland Clinic’s Dr. Steven Nissen told CNN Tuesday. “This is an important trial and I think the term ‘landmark’ is appropriate.”
Nissen emphasized, though, that these are just topline results shared by news release. He emphasized that it’s crucial to see full results presented at a scientific conference and published in a peer-reviewed journal. Specifically, he noted the news release didn’t discuss adverse events or the specific effects on each measure of heart risk: cardiovascular death, heart attack and stroke.
“That doesn’t mean it’s not a good result,” he said, “it just means we don’t know.”
Novo Nordisk’s executive vice president for development, Martin Holst Lange, said in the news release that the trial “has demonstrated that semaglutide 2.4mg has the potential to change how obesity is regarded and treated.”
The findings, once peer-reviewed and published in a medical journal, may encourage more doctors to prescribe the wildly popular weight loss drug, but could also potentially help improve insurance coverage, physicians told CNN.
“If the Select study is positive, it will add to the growing body of evidence that weight loss is not just cosmetic and will encourage insurers to pay for medications that reduce weight,” Dr. Willa Hsueh, director of the Diabetes and Metabolism Research Center at Wexner Medical Center at The Ohio State University, told CNN before the results were released.
Wegovy costs $1,349 a month before insurance, and coverage has been difficult for many patients in the US.
“For weight loss right now, I would call it poor,” said Dr. Jena Shaw Tronieri, director of Clinical Services at the Center for Weight and Eating Disorders at the Perelman School of Medicine at the University of Pennsylvania, in an interview before the trial results. “We do see a lot of patients struggling to access these medications.”
Novo Nordisk said Wegovy appeared to have a “safe and well-tolerated profile” in the study, in line with what it has seen in previous trials.
The company said it will submit applications with regulators to add the cardiovascular benefits to the drug’s prescribing information, and said it will present detailed results from the trial at a scientific conference later this year.
Those steps are key to improving reimbursement, Nissen said.
“I can tell you that the pharmacy benefit managers who now rule the world will not generally pay for something based on a press release,” he said.
Nissen is leading a similar trial for tirzepatide, a drug made by Eli Lilly and sold for type 2 diabetes as Mounjaro. It’s awaiting US Food and Drug Administration approval for weight loss as well. In an interview before the results of the Wegovy trial, he said expectations may have been for a benefit of about 15%.
“I think for a drug that requires patients to inject weekly, that’s relatively expensive, a meaningful result … is a 15% relative risk reduction,” Nissen said. But he noted he’d be disappointed with that level. “Something more Iike 20% for a biological is a more reasonable one.”

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