File photo: A 0.25 mg injection pen for Novo Nordisk’s weight loss drug Wigoby is shown in this photo illustration on September 1, 2023 in Oslo, Norway. Photo credit: Victoria Klesty/REUTERS
Popular weight loss drug Wegoby reduced the risk of serious heart disease by 20 percent in a large international study, and experts say it could change the way doctors treat certain heart disease patients. There is.
This study documents for the first time that obesity drugs can not only help people lose weight but also safely prevent heart attack, stroke, or heart-related death in people who already have heart disease, but not diabetes. This is what I did.
The findings could change the perception that new classes of obesity drugs are cosmetic treatments and put pressure on health insurance companies to cover them.
“We’re moving from a type of therapy that reduces weight to a therapy that reduces cardiovascular events,” said Dr. Michael Linkoff, lead author of the study and a heart expert at the Cleveland Clinic.
Wegovy is a high-dose version of the diabetes drug Ozempic, which has already been shown to reduce the risk of serious heart disease in people with diabetes. A new study looked at whether the same was true for people who don’t have the disease.
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Losing weight has been known for years to improve heart health, but it has been proven to reduce certain risks, said Mayo Clinic heart expert Dr. Francisco López Jiménez. He said there are still no safe and effective obesity treatments. He expects the new findings to change treatment guidelines and “dominate the conversation” for years to come.
“These are the people who need this drug the most,” said López Jiménez, who was not involved in the study.
Experts say there are about 6.6 million people in the United States like those tested in this study.
The results were published Saturday in the New England Journal of Medicine and presented at a medical conference in Philadelphia. Novo Nordisk, the maker of Wigovy and Ozempic, has asked the U.S. Food and Drug Administration to list heart benefits on the label of Wigovy, as it does with Ozempic.
The new study was paid for by the company and involved more than 17,500 participants from 41 countries. Participants were over 45 years old, had a BMI of 27 or higher, and were followed for an average of over 3 years. Although they were taking common medications to treat heart disease, they were randomly assigned to receive weekly Wegoby injections or dummy injections.
In the study, 569 (6.5%) of those who received the drug had a heart attack, stroke, or died from heart-related causes, compared with 701 (8%) of those who received the dummy injection. It turned out that it did. This translated into an overall 20% reduction in the risk of these outcomes, the researchers reported.
This decline appears to have been primarily driven by differences in heart attacks, but the number of serious health complications reported is too small to determine whether individual results were caused by the drug or due to chance. I couldn’t decide.
Study volunteers who took Wegovy lost about 9% of their body weight, while those in the placebo group lost less than 1%.
Dr. Martha Gulati, a heart expert at Cedars-Sinai Medical Center in Los Angeles, noted that the Wegovy group also had lower key markers of heart disease, including inflammation, cholesterol, blood sugar, blood pressure, and waist circumference. Changes in these markers began early in the study, before the participants had significantly lost weight.
“For me, how this drug works means more than just weight loss,” said Gulati, who had no role in what she called the groundbreaking study. said.
Still, it “remains unclear” how much of the results are due to weight loss or the benefits of the drug itself, an editorial accompanying the study noted.
About one-third of all study volunteers reported serious side effects. About 17 percent of the Wegovy group and 8 percent of the comparison group discontinued the study, primarily because of nausea, vomiting, diarrhea, and other stomach-related problems.
Almost three-quarters of participants were male, and nearly 84 percent were white. Gulati and her colleagues said future studies should include more women and racial and ethnic minorities.
Wegovy is part of a new class of injectable drugs for obesity. The U.S. Food and Drug Administration on Wednesday approved Eli Lilly’s Zepbound, a version of the diabetes drug Mounjaro, for weight management.
Both are expensive, with monthly fees around $1,300 for Wegovy and $1,000 for Zepbound. And both have been in short supply for months, with manufacturers promising to increase supply.
These drugs are often not covered by private health insurance or are subject to strict prior authorization requirements. Medicare, the government’s health insurance plan for older Americans, is prohibited from covering only drugs for weight loss. But drug companies and obesity treatment advocates are pushing for expanded coverage, including asking Congress to pass legislation that would require Medicare to pay for the drugs.
Dr. Mark McClellan, former director of the Centers for Medicare and Medicaid Services and the FDA, said new research and other findings showing that obesity drugs have a direct impact on costly health problems could change the way coverage is calculated. He said it was possible. . He pointed out that in 2006, Medicare was allowed to cover weight loss surgery to treat complications of severe obesity, if not obesity itself.
That approach “could end up making sense here, too,” he says.
