Results from a multicenter, international clinical trial reported by Cleveland Clinic physicians showed that semaglutide reduced cardiovascular events by 20% in adults who were overweight or obese, had cardiovascular disease, and did not have diabetes. It shows.
Semaglutide is primarily prescribed to adults with type 2 diabetes, but it is also approved for chronic weight management in adults who are obese or overweight and have at least one other health problem. In this trial, patients treated with semaglutide lost an average of 9.4% in body weight and saw improvements in other risk factors for cardiovascular disease.
result obtained from The “SELECT – Semaglutide and Cardiovascular Outcomes in Non-Diabetic Overweight or Obese Patients” trial was presented today at the Current Scientific Sessions of the American Heart Association’s 2023 Scientific Sessions, and concurrently New England Medical Journal.
In this study, weekly injections of semaglutide at a dose of 2.4 mg reduced the risk of cardiovascular death, non-fatal heart attack, and increased risk of non-fatal heart attack in patients with pre-existing cardiovascular disease and overweight or obesity, but without diabetes. or was found to be superior to placebo in reducing the risk of death from non-fatal stroke. Average follow-up of 40 months.
Dr. Michael Linkoff
“Overweight and obesity are known to increase the risk of cardiovascular events. While reducing cardiovascular disease by treating high cholesterol, hypertension, and diabetes is standard therapy, treating obesity “The concept of reducing cardiovascular complications in patients with overweight and obesity has been hampered by a lack of evidence that lifestyle and pharmacological interventions for overweight and obesity improve cardiovascular disease outcomes,” said lead author of SELECT. said Michael Linkoff, M.D., vice chair of research in the Department of Cardiovascular Medicine at the Cleveland Clinic. “This is the first pharmacological intervention for overweight or obesity shown in a rigorous way to reduce the risk of cardiovascular events.”
By 2035, more than half of the world’s population is predicted to be overweight or obese. It is estimated that in 2015, 4 million people died worldwide due to high body mass index (BMI), and more than two-thirds of these deaths were caused by cardiovascular disease. .
Semaglutide was initially approved and is the most frequently prescribed GLP-1 receptor agonist for adults with type 2 diabetes, but in 2021 it will be used in adults with obesity or overweight with at least one weight-related comorbidity. FDA-approved for chronic weight management. Although semaglutide’s weight loss effects appear to occur primarily through appetite suppression, the drug also has potential to reduce cardiovascular risk, including improving blood sugar levels, lowering blood pressure and cholesterol levels, reducing inflammation, and having beneficial effects on the heart muscle. There are other effects as well. and blood vessels.
In the SELECT study, which ran from October 2018 to June 2023, researchers enrolled patients aged 45 and older with pre-existing cardiovascular disease, a BMI of 27 or higher, and no history of diabetes. More than 17,000 patients from 41 countries who have had a previous heart attack, stroke, and/or peripheral artery disease were enrolled to receive once-weekly injections of semaglutide 2.4 mg or a placebo. After random assignment, participants were followed for an average of 40 months.
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.
Death from a cardiovascular event, non-fatal myocardial infarction (heart attack), or non-fatal stroke occurred in 6.5% of patients treated with semaglutide during the trial compared with 8.0% of patients receiving placebo. , semaglutide reduced the relative risk by 20%. The risk reduction was similar for men and women, different ethnicities, patient ages, and baseline weight levels.
There were no unexpected safety issues with semaglutide in this trial. More patients discontinued semaglutide (16.6%) than placebo (8.2%). This was mainly due to gastrointestinal symptoms such as nausea and diarrhea. These gastrointestinal symptoms are not uncommon with this class of drugs, especially when starting the drug or increasing the dose. There was a slightly higher incidence of gallbladder damage in the semaglutide and placebo groups (2.8% vs. 2.3%, respectively), but this has also been previously reported in other studies using GLP-1 drugs. Importantly, semaglutide was not associated with an increased risk of severe gastrointestinal disorders, pancreatitis, psychiatric disorders, or kidney damage.
“Although there is increasing recognition that obesity and overweight are actually metabolic diseases, effective treatments are still quite limited,” says Dr. Linkoff. “This study of semaglutide demonstrates the efficacy of a new pathway to reduce the excess risk associated with obesity for important and potentially fatal cardiovascular complications.”
One limitation of this study was that only patients with pre-existing cardiovascular disease were included. The effect of semaglutide on the primary prevention of cardiovascular events in people who are overweight or obese but without a history of cardiovascular disease has not been studied.
The trial was sponsored by Novo Nordisk, which developed semaglutide. Dr. Linkoff has received consulting fees from Novo Nordisk.
