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New analyzes of the longest clinical trial of the weight-loss drug Wegovy are shedding light on how quickly it helps. People lose weight, how long they continue to lose weight, and how safe the drug is when used for more than four years.
The analysis – the results of the test called Select He showed. Last year, Wegovi significantly reduced heart risk in addition to helping with weight loss — and the drug may protect the heart in ways beyond weight loss, researchers said, raising new questions about how wildly popular drugs in this drug class should be. Used – and covered by insurance.
“The implications are profound,” he said Dr. Harlan KrumholzCardiologist and Scientist at Yale University and Yale New Haven Hospital Not Involved in Research Noting that a second Research This week it showed a similar finding for heart failure. “We've never seen a drug with such heart benefits.”
More than 25,000 people in the U.S. are starting Wegovin every week, according to drugmaker Novo Nordisk. he said. This month. And in KFF Poll Released on Friday, 6% of respondents said they were currently using drugs known as GLP-1 receptor agonists in this category. That translates to more than 15 million Americans.
An important question about these blockbuster drugs is how widely and for how long they have been studied. The Select trial, funded by Novo Nordisk; He showed. Last year, Wegovi reduced the risk of heart attack, stroke or heart-related death by 20 percent in people who were obese and at risk for cardiovascular problems. It included more than 17,600 people from 41 countries between 2018 and 2021 and was followed for several years.
Researchers continue to extract the data, and the new analyzes were presented on Monday European Congress on Obesity And published in the magazine Natural medicine, show results for up to four years for people taking Wegovy. Here are some of the main uses:
The analysis An average of more than 10% weight loss has been shown for people using semaglutide, an ingredient found in Wegovy. compared to 1.5% for study participants who received a placebo. The researchers, Dr. Donna Ryan of the Pennington Biomedical Research Center in Baton Rouge, Louisiana, said this trend shows that the drug participants usually lost weight for 65 weeks, or one year and three months.
A Previous clinical trial It showed an average weight loss for Wegovy: 15% on average over 68 weeks, compared to 2.4% for people who got a placebo. In the new analysis, the researchers said that in addition to some differences in the people enrolled in each trial, the previous study was specifically designed for weight loss and included a more structured lifestyle around diet and exercise compared to the current trial. Designed to test whether the drug prevents cardiac events.
The results showed that the average weight loss of 10% for those using Wegovy lasted up to 208 weeks, or four years.
Patients stay on medication while continuing to lose weight. Other studies have shown that many people regain their weight after stopping the drug, including one Published In December from Novo Nordisk competitor Eli Lilly, people using the GLP-1 drug Zipbod, which uses the active ingredient tirzepatide and targets a second hormone called GIP, lost an average of 21 percent of their body weight over 36 weeks. The participants were then split into two groups: those who stayed on the drug lost an additional 5.5% of their body weight, while those who switched to the placebo gained 14% of their weight.
However, not everyone was able to recover that much Weight. The study looked at how many people maintained at least 80% weight loss after the first 36 weeks, and as many as 90% of those who continued with the drug maintained it, compared to 17% of those who switched to placebo. Lose that much weight without medication.
In the new analysis, the researchers reported that after two years, 68% of those taking Wegovin had lost at least 5% of their body weight, compared to 21% of those on placebo. About 23% of people on Wegovy lost at least 15% of their body weight, compared to 1.7% on placebo. And 5% of people on the drug lost more than 25% of their body weight, compared to 0.1% on the placebo, studies show that top-line findings are average. Everyone has a different experience with medicine.
Overall, more people on Wegovy decided to stop participating in the trial because of side effects than those on placebo: 17 percent of those taking the drug compared to 8 percent on placebo, the result. Previously He reported. And the side effects are well-known with these drugs: mainly gastrointestinal disturbances such as nausea, diarrhea, vomiting and constipation that affect people in the first months of the study as the dose increases.
The researchers said that no new safety signals were found in the recent analysis. Acute pancreatitis or pancreatitis was not seen at a higher rate among those on Wegovy than on placebo, although gallbladder disorders such as gallstones occurred in 2.8% of those on Wegovy, compared to 2.3% of those on placebo. Both are included in the warnings in the medicine Order information Because they were previously seen in experiments.
When the full results of the selection trial were first presented, the main question was whether the 20% reduction in heart risk was due to weight loss alone or to some other drug prevention. The new one Analysis It suggests that there is something else in the game.
This is because a reduction in the risk of heart attack or other events was seen even in people using Wegovin who did not lose weight.
“You may not even need to lose weight to get the cardiovascular benefits,” says Dr. Daniel Drucker, who pioneered the GLP-1 research at the University of Toronto and was not involved in the new study. Analyzes. Here's what GLP-1 does: It's cardioprotective, at least in animals, whether you have diabetes or not, independent of your obesity, and you don't want to lose weight. He said.
An Analysis leading John Deanfield The reduction in major adverse cardiovascular events in the study on Wegovi by University College London was similar among those who lost 5% or more of their body weight and those who lost less or even the same compared to placebo. Weight increased.
“This suggests alternative mechanisms for improved cardiovascular outcomes beyond reducing adiposity” or body fat, the researchers concluded.
A separate study has been published Monday About heart failure, b Wegovy has It has been seen. A big advantage, the same thing pointed out, said Krumholz.
“These two studies show that these anti-obesity drugs are heart-healthy drugs,” he wrote in an email. “In people with established coronary artery disease or in people with certain heart failure, the benefit to the heart occurs regardless of the amount of weight loss.”
Drucker expressed skepticism that GLP-1 drugs provide such benefits by reducing inflammation.
“We can't ignore lowering blood pressure or triglycerides, and weight loss should help a little bit, and glucose should help a little bit,” he said.
But based on His laboratory In research, he says, “One of my favorite theories is inflammation, because we know that people with cardiovascular disease have increased inflammation in their blood vessels and heart.
According to Drucker, studies have shown that GLP-1 drugs can reduce the harmful inflammation the lab is studying. He said he receives communications from people with conditions such as Covid-related brain fog, ulcerative colitis and arthritis — which are driven by inflammation — who think their symptoms have improved while using GLP-1 drugs. Those links must be demonstrated in clinical studies to be considered definitive.
The results in the selection trial raise the question of whether people who are not obese or overweight but have had a heart attack or stroke could benefit from taking a drug like Wegovi to prevent another event — something that needs further study.
And Drucker said the results mean insurers should more widely cover drugs that cost $1,000 or more a month.
“We really need to reconsider these criteria for reimbursing the drugs because they can improve health and save lives and save health care dollars for people with obesity and heart disease, even without much weight loss,” he said. “You don't even need to lose weight to reduce heart attack, stroke and death.”