Efficacy of Semaglutide in Obesity Without Diabetes

Efficacy of Semaglutide in Obesity Without Diabete

Research Highlights:

In a large international clinical trial, people who were obese or overweight, but without diabetes, who took semaglutide for more than 3 years had a 20% lower risk of heart attack, stroke, or death due to cardiovascular disease and They lost an average of 9.4% of their body. weight. Semaglutide is a GLP-1 medication prescribed primarily for people with type 2 diabetes. It is also approved by the FDA for weight loss in people with obesity.
The randomized, double-blind trial enrolled more than 17,500 adults in 41 countries who were overweight or obese and who had previously had a heart attack, stroke, and/or had peripheral artery disease but did not have type 1 or type 2 diabetes.
According to the researchers, the SELECT trial results are the first time that any medication or lifestyle therapy has been shown to reduce cardiovascular events in overweight or obese adults who did not have type 1 or type 2 diabetes.

Background

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes. It is unknown whether semaglutide can reduce the cardiovascular risk associated with overweight and obesity in the absence of diabetes.

Methods

In a multicenter, double-blind, randomized, placebo-controlled, event-based superiority trial, we enrolled patients 45 years of age or older who had preexisting cardiovascular disease and a body mass index (weight in kilograms divided by the square of height in meters) of 27 or more, but without a history of diabetes.

Patients were randomly assigned in a 1:1 ratio to receive once-weekly subcutaneous semaglutide at a dose of 2.4 mg or placebo.

The primary cardiovascular endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in an analysis of time to first event. Safety was also evaluated.

Results

A total of 17,604 patients were enrolled ; 8,803 were assigned to receive semaglutide and 8,801 to receive placebo. The mean (±SD) duration of exposure to semaglutide or placebo was 34.2 ± 13.7 months, and the mean duration of follow-up was 39.8 ± 9.4 months.

A primary cardiovascular event occurred in 569 of 8803 patients (6.5%) in the semaglutide group and in 701 of 8801 patients (8.0%) in the placebo group (hazard ratio, 0.80; range 95% confidence, 0.72 to 0.90; P<0.001).

Adverse events leading to permanent discontinuation of the trial product occurred in 1461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group (P<0.001).

Efficacy of Semaglutide in Obesity Without Diabete

Conclusions

In patients with preexisting cardiovascular disease and overweight or obesity but without diabetes, weekly subcutaneous semaglutide 2.4 mg was superior to placebo in reducing the incidence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. in a medium follow-up. 39.8 months.

(Funded by Novo Nordisk; ClinicalTrials.gov, NCT03574597)

Efficacy of Semaglutide in Obesity Without Diabetes

Weekly subcutaneous administration of 2.4 mg semaglutide demonstrates superiority over placebo in treating obesity without diabetes.