Research highlights:
- A large international clinical trial found that people who were obese or overweight but did not have diabetes had a 20% lower risk of heart attack, stroke, or death from cardiovascular disease when they took semaglutide for more than three years; 9.4% of the body decreased. weight. Semaglutide is her GLP-1 drug that is primarily prescribed to her type 2 diabetic patients. It is also approved by the FDA for weight loss in obese individuals.
- This double-blind, randomized trial included 41 patients who were overweight or obese, had a previous heart attack, stroke, or peripheral artery disease, but did not have either type 1 or type 2 diabetes. More than 17,500 adults from Cambodia were enrolled.
- According to researchers, the results of the SELECT trial are the first to demonstrate that pharmacotherapy or lifestyle therapy reduces cardiovascular events in overweight or obese adults who do not have type 1 or type 2 diabetes. It is about.
Embargoed until Saturday, November 11, 2023 at 8:30 a.m. ET
PHILADELPHIA, November 11, 2023 — A large international clinical trial found that people who were obese or overweight but did not have diabetes were less likely to die from heart attacks, strokes, or cardiovascular disease if they took semaglutide for more than three years. Risk is reduced by 20%, averaging 9.4% of body weight. Semaglutide is her GLP-1 drug that is primarily prescribed to her type 2 diabetic patients. It is also approved by the FDA for weight loss in obese individuals.
These results were shared today at the latest scientific presentation at the American Heart Association. Academic Session 2023. The conference, to be held in Philadelphia from November 11-13, is the premier global gathering to exchange updates on the latest scientific advances, research, and evidence-based clinical practice in cardiovascular science. . The full text of the manuscript is available today. New England Medical Journal.
“This news is very reassuring for people who are overweight or obese, because treatments specifically aimed at managing obesity and overweight in people without type 1 or type 2 diabetes have not been tested in randomized trials. “It has not been shown to affect cardiovascular outcomes.” Study lead author A. Michael Linkoff, MD, is vice chair for research in the Robert and Suzanne Tomsic Department of Cardiovascular Medicine and an interventional cardiologist in the Seidel and Arnold Miller Family Heart, Vascular, and Thoracic Institute at the Cleveland Clinic. be.
Previous studies have confirmed the benefits of semaglutide in blood sugar control, reduced cardiovascular disease events, and weight loss in patients with type 2 diabetes, but this study specifically investigated the potential effects of semaglutide on cardiovascular disease. He did not have type 1 or type 2 diabetes.
Study participants were randomly assigned to receive 2.4 milligrams of semaglutide (an FDA-approved dose of semaglutide for weight management) or a placebo once a week, which is the FDA-approved dose of semaglutide for type 2 diabetes. Higher than the semaglutide dose limit of 2.0 mg/week. . Each study participant used a “pen” to inject the drug or a placebo into a skin fold on their stomach, thigh, or upper arm on the same day each week. Doses started at 0.24 mg and were gradually increased every 4 weeks. The dose was 2.4 mg, and the average follow-up period for all participants was 40 months. No one involved in the study, neither the participants nor the medical professionals nor the trial researchers, knew which participants were receiving semaglutide or a placebo.
In addition to taking either semaglutide or a placebo in the trial, all participants also received standard treatments for cardiovascular disease, such as cholesterol-regulating drugs, antiplatelet therapy, beta-blockers or other treatments. The authors note that heart disease diagnoses vary among participants, so treatment was tailored to each individual’s diagnosis and needs, as well as treatment guidelines in their country of residence.
The study was conducted from October 2018 to June 2023 and the results showed that:
- Participants who took semaglutide had a 20% reduced risk of heart attack, stroke, and death from cardiovascular disease compared to participants in the placebo group.
- Participants in the semaglutide group lost an average of 9.4% of their body weight, compared to a 0.9% reduction in adult body weight in the placebo group.
- Although the study found no new safety concerns, the SELECT trial is the largest and longest trial (4.5 years) of semaglutide in adults without type 1 or type 2 diabetes, so the researchers He points out that this is reassuring.
- The number of serious adverse events was lower in the semaglutide group. Previous studies of drugs in the GLP-1 receptor agonist class have shown an association with gallbladder damage, with SELECT showing a slightly higher rate of gallbladder damage in the semaglutide and placebo groups (2.8% vs. 2.3%, respectively). ). .
- Semaglutide was discontinued more frequently than placebo due to gastrointestinal intolerance, a known side effect of this type of drug. However, there was no increased incidence of serious gastrointestinal events.
- The researchers noted that the drug did not lead to an increase in the incidence of pancreatitis, which was a concern with previous drugs of this type.
- Of note, other weight loss drugs that are not GLP-1 receptor agonists are associated with an increased risk of mental illness or cancer. These risks were not increased with semaglutide in the SELECT trial.
“It is estimated that within about 10 years, more than half of the world’s population will be overweight or obese,” says Dr. Linkoff. “And while GLP-1 drugs are often prescribed to patients with vascular disease and type 2 diabetes, they can also be used in people who do not have type 1 or type 2 diabetes but have vascular disease and are overweight or obese. There are a significant number of people for whom these drugs are prescribed, but they are often unavailable due to access issues, insurance coverage, or other factors. This population may benefit from semaglutide. Importantly, our results demonstrate that the magnitude of cardiovascular risk reduction with semaglutide in people without type 1 or type 2 diabetes is similar to that observed in people with type 2 diabetes. Our findings expand the opportunity to treat patients with overweight or obesity and pre-existing heart disease without type 1 or type 2 diabetes, reducing the risk of secondary cardiovascular events, including death. This presents an opportunity to significantly reduce the risk of
This study had several limitations. The trial only included adults with a history of cardiovascular disease, so it did not look at primary prevention of cardiovascular disease (in people without a history of heart attack, stroke, or peripheral artery disease). Additionally, 28% of study participants were women, which is disproportionate to the number of women with cardiovascular disease or overweight or obesity in the general population.
The study authors aimed to identify mediators of cardiovascular effects to determine the extent to which results were driven by direct effects, such as reduction of metabolically unhealthy body fat, positive effects on inflammation and blood sugar, and It notes that additional analyzes of the results are planned, including studies aimed at The effect of the drug itself, or a combination of one or more variables, on plaque buildup in the arteries.
Research background:
- More than 17,500 people enrolled in this international study. Since 2018, 72% of him in 41 countries were adult males.
- All participants were over the age of 45 and had a body mass index (BMI) of 27 kg/m2 or higher, and over 70% had a BMI of 30 or higher, indicating obesity.
- All participants in the study had a history of previous cardiovascular disease, such as heart attack, stroke, or peripheral artery disease.
- Although none of the participants had type 1 or type 2 diabetes at the time they entered the study, about two-thirds of the participants had an A1C level (the percentage of hemoglobin in red blood cells that has glucose or sugar attached) of 5.7. It was ~5.7. % to 6.4%, meeting diagnostic criteria for prediabetes, a precursor to type 2 diabetes.
- SELECT’s semaglutide dose of 2.4 mg/week is the same as the maximum FDA-approved dose for weight loss, but is different from the approved dose for type 2 diabetes (typically 1.0 to 2.0 mg/week).
Obesity rates have increased in most countries since the 1980s, and the 2023 World Obesity Atlas estimates that 51% of the world’s population will be overweight or obese by 2035. This is concerning because obesity directly contributes to the development of cardiovascular disease and the risk of premature cardiovascular death, as noted in the Obesity and Cardiovascular Disease Association’s 2021 Scientific Statement. be.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, a type of drug that simulates the function of the body’s natural incretin hormones, which helps lower blood sugar levels after meals. Regulating these hormone levels also makes you feel fuller, so you consume fewer calories throughout the day and most people lose weight over time. Semaglutide was first approved by the FDA to treat type 2 diabetes and in 2021 for chronic weight management in obese adults.
Co-authors, disclosures, and funding sources are listed in the abstract and manuscript.
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