Wegovy Shows Early Reduction in Major Adverse Cardiovascular Events
Semaglutide resulted in a significant reduction in the risk of MACE within the first 3 months of treatment compared to placebo.
A secondary post hoc analysis of a phase 3 trial showed that treatment with semaglutide (Wegovy) resulted in early reduction in risk of major adverse cardiovascular events (MACE) in adult patients with obesity and established cardiovascular disease (CVD), Novo Nordisk said in a release.1 The data was presented at the 2025 European Congress on Obesity, held May 11 to 14 in Malaga, Spain.
Wegovy Shows Early Reduction in Major Adverse Cardiovascular Events / Ole - stock.adobe.com
"Cardiovascular disease is linked to two thirds of obesity-related deaths, and with obesity on the rise, there is an urgent need for effective treatments,” Jorge Plutzky, MD, lead study author, said in a release.1 “Building on the landmark SELECT trial, that showed that semaglutide 2.4 mg decreased heart disease events in people with overweight or obesity and established cardiovascular disease, in this secondary analysis, there was early reduction in heart disease events observed with semaglutide 2.4 mg prior to what is typically considered significant weight loss.”
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SELECT (NCT03574597) was a multicenter, randomized, double-blind, placebo-controlled, event-driven, phase 3 superiority trial that evaluated the efficacy of semaglutide compared to placebo as an adjunct to cardiovascular standard of care for reducing the risk of MACE in adult patients with established CVD, overweight or obesity, and no history of diabetes. The study cohort included 17604 adult patients aged 45 years or older who had a BMI of 27 kg/m^2 or greater.
Patients received either semaglutide or placebo as an adjunct to standard of care for 31 to 59 months. Those who received the therapy started treatment at 0.24 mg once a week and were gradually increased every 4 weeks up to 2.4 mg. Exclusion criteria included a history of myocardial infarction or stroke, an HbA1c of 48 mmol/mol or greater, a history of type 1 or type 2 diabetes, history of chronic pancreatitis, end stage renal disease, and chronic or intermittent haemodialysis.
The study found that treatment with semaglutide resulted in a significant reduction in the risk of MACE within the first 3 months of treatment compared to placebo. Over the first 6 months, a similar reduction was seen for risk of cardiovascular death, as well as lowered composite heart failure risk and reduced death from any cause.
Additionally, 33.4% of patients who received semaglutide reported serious adverse events, compared to 36.4% of patients who received placebo. In the semaglutide group, 16% discontinued the therapy, compared to 8% in the placebo group. Gastrointestinal disorders were the most common adverse event leading to discontinuation, which occurred in 10% of patients receiving semaglutide and 2% of those receiving placebo.
“For people with obesity and existing cardiovascular disease, preventing another heart attack or stroke is vitally important,” Jason Brett, MD, principal medical head at Novo Nordisk, said in a release.1 “Seeing this SELECT secondary data demonstrate that patients experienced MACE risk reduction within three months is remarkable. These latest findings add to the growing evidence on the effect of Wegovy in addressing cardiovascular disease.”
In previously announced results from the SELECT trial, semaglutide treatment resulted in a 20% reduction in MACE compared to placebo.2 The positive data was used as the basis for a supplemental New Drug Application (sNDA) for the indication of reducing risks of MACE, which was approved by the FDA on March 8, 2024.3
READ MORE: Obesity Management Resource Center
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