Semaglutide, the active ingredient in Ozempic and Wigovy, is effective in reducing overweight and cardiovascular disease patients, according to large-scale randomized results presented today at the American Heart Association’s Scientific Sessions meeting in Philadelphia. Reduced risk of serious cardiovascular events by 20% in obese people.
Semaglutide was previously shown to reduce cardiovascular events by 25% in patients with diabetes. However, these results from the SELECT trial suggest a broader study among the 20 million people with coronary artery disease in the United States, most of whom are overweight or obese, but only 30% of whom have diabetes. It opens the door to use. Nearly 90% of the 17,604 people in the study were taking statins, so semaglutide could be positioned as an add-on therapy to statins to further reduce cardiovascular risk.
Photos of side effects in clinical trials were controversial. Researchers tallied that people randomized to treatment with semaglutide had a lower incidence of serious side effects than those randomized to placebo (33.4% vs. 36.4%). . However, side effects leading to treatment discontinuation occurred twice as often in the semaglutide group than in the placebo group (16.6% vs. 8.2%), including gastrointestinal disturbances (nausea, diarrhea), which are well-documented disadvantages of semaglutide. . , was the most common reason.
Those randomly given semaglutide lost an average of 9.4% of their body weight. However, researchers and discussants of the study’s results said there was a strong suggestion that semaglutide had a direct protective effect against cardiovascular disease, apart from reducing risk through weight loss.
“I think most of us believe that part of this is weight loss, but I think that’s an oversimplification of a very complex molecule, complex receptors on multiple tissues. .And I don’t think it’s that simple,” said A. Michael. Linkoff is vice chair of research in the Department of Cardiovascular Medicine at the Cleveland Clinic in Ohio and lead author of a research paper describing the findings published in the journal. New England Medical Journal Coinciding with Linkoff’s presentation at the AHA conference.
Because the SELECT trial was a large, double-blind, randomized, multicenter study, the results are considered convincing. However, over 80% of the participants were white and over 70% were male, so there are questions about how applicable the results are to more diverse populations.
To participate in the trial, patients must be 45 years of age or older, have a BMI of 27 or higher, and have cardiovascular disease, which for the purposes of this trial is defined as myocardial infarction, previous stroke, or symptomatic were defined as having peripheral disease. Arterial disease. The trial was designed to test the protective effects of semaglutide in people without diabetes, so people with a diagnosis of diabetes or a hemoglobin A1C (HbA1C) level of 6.5% or higher were excluded. The primary endpoint was a composite of cardiovascular and nonfatal death. Myocardial infarction or non-fatal stroke.
In addition to taking statins and having low LDL levels, most of those in the study (86.2%) were taking platelet aggregation inhibitors (such as aspirin), and about the same number (70.2%) were taking beta-blockers. I was taking it. The average BMI was 33.3, but 28.5% of the participants were in the overweight range (BMI less than 30).
The average duration of treatment with semaglutide or placebo was 34 months.
Of the 8,803 patients in the semaglutide group, 569 (6.5%) experienced one of the composite primary endpoints, compared with 701 of 8,801 (8%) in the placebo group. That’s a 20% difference. Secondary endpoints were also stacked in favor of semaglutide.
“20% may not sound like a big number, but that’s what we’re doing for heart disease. We’re still the world’s largest number. “We are gradually reducing heart disease, which is the cause of death for many people.”
The SELECT trial was funded by Novo Nordisk, which manufactures and sells Ozempic, a low-dose version of semaglutide approved for the treatment of type 2 diabetes, and Wigovy, a high-dose version approved for weight loss. provided. The trial tested weekly subcutaneous injections of a 2.4 mg dose of semaglutide, one of the two doses included in Wegovy.
Semaglutide, a glucagon-like peptide-1 (GLP-1) inhibitor and a member of the drug family that includes tirzepatide, was approved by the FDA on Wednesday as a weight-loss drug sold by Eli Lilly as Zepbound. GLP-1 inhibitors have been transformed from treatment for type 2 diabetes to weight loss drugs, and sales are rapidly increasing.
Although the SELECT trial evaluated semaglutide in people who already had cardiovascular disease, Professor Linkoff said most drugs, including statins, are effective in that setting (secondary prevention), and primary prevention (secondary prevention). In this context, it means people who are overweight or obese). People without established cardiovascular disease.
In the accompanying editorial, New England Medical JournalAmit Khera, MD, of the University of Texas Southwestern Medical Center in Dallas and Tiffany M. Powell Wiley, MD, MPH, of the National Heart, Lung, and Blood Institute and the National Institute on Minority Health and Health Disparities, said: It was announced on . The SELECT trial shows that it is a welcome treatment option for people at risk of cardiovascular events, even though their risk factors are well controlled and their LDL levels are very low. However, they also noted the “significant costs” of GLP-1 inhibitor treatment at current prices, and said that it is important to understand the “upstream basis” of obesity and the communities most vulnerable to experiencing it. advocated for continuing to address downstream impacts on