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Semaglutide 'A New Pathway' to CVD Risk Reduction: SELECT

November 2, 2023 | MKPEP

Final results of the SELECT trial have shown that the anti-obesity drug semaglutide (Wegovy) produced a consistent reduction of around 20% vs placebo across major cardiovascular event endpoints over the approximately 3-year follow-up in patients with overweight or obesity and cardiovascular disease but not diabetes.

"This is a very exciting set of results. I think it is going to have a big impact on a large number of people," lead investigator A. Michael Lincoff, MD, vice chair for research in the department of cardiovascular medicine at the Cleveland Clinic, Cleveland, Ohio, told theheart.org | Medscape Cardiology.

"And from a scientific standpoint, these data show that we now have a new pathway or a new modifiable risk factor for cardiovascular disease that we can use in our patients who have overweight or obesity," he added.

The trial involved 17,604 patients with a history of cardiovascular disease and a BMI of 27 or above (mean BMI was 33), who were randomly assigned to the glucagon-like peptide 1 (GLP-1) agonist semaglutide, given by subcutaneous injection once weekly at a gradually escalating dose up to 2.4 mg daily by week 16, or placebo. The mean baseline glycated hemoglobin level was 5.8% and 66.4% of patients met the criteria for prediabetes.

Patients lost a mean of 9.4% of body weight over the first 2 years with semaglutide versus 0.88% with placebo.

The primary cardiovascular endpoint — a composite of death from cardiovascular causes, nonfatal myocardial infarction (MI), or nonfatal stroke — was reduced significantly, with a hazard ratio of 0.80 (95% CI, 0.72 - 0.90; P < .001).

Death from cardiovascular causes, the first confirmatory secondary endpoint, showed a 15% reduction (HR, 0.85; P = .07) but this missed meeting criteria for statistical significance, and because of the hierarchical design of the trial, this meant that superiority testing was not performed for the remaining confirmatory secondary endpoints.

However, results showed reductions of around 20% for the heart failure composite endpoint and for all-cause mortality, with confidence intervals that did not cross 1.0, and directionally consistent effects were observed for all supportive secondary endpoints.

The hazard ratio for the heart failure composite endpoint was 0.82 (95% CI, 0.71 - 0.96), and the HR for death from any cause was 0.81 (0.71 - 0.93). Nonfatal MI was reduced by 28%, hazard ratio 0.72 (95% CI, 0.61 - 0.85).

The effects of semaglutide on the primary endpoint appeared to be similar across all prespecified subgroups.

Adverse events leading to discontinuation of treatment occurred in 16.6% in the semaglutide group, mostly gastrointestinal (GI) effects, and in 8.2% in the placebo group.

The trial results were presented by Lincoff today at the 2023 American Heart Association (AHA) Scientific Sessions, being held in Philadelphia. They were also simultaneously published online in the New England Journal of Medicine.

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