Semaglutide reduced cardiovascular events by 20% in adults with obesity or who are overweight, without diabetes mellitus, study results have shown.
The SELECT trial, results of which were published in the New England Journal of Medicine on 11 November 2023, included 17,604 patients who were overweight or had obesity and were aged over 45 years or older with pre-existing cardiovascular disease. Patients were assigned to receive 2.4mg of semaglutide or placebo weekly for a mean duration of 34 months.
Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist, traditionally used for treatment of type 2 diabetes mellitus. In March 2023, NICE recommended use of semaglutide for weight management, alongside a reduced-calorie diet and increased physical activity through specialist NHS weight management services, for a maximum of two years.
The two-year prescribing limit led to some reservation among healthcare professionals owing to the relapsing nature of obesity.
In the study, researchers found that primary cardiovascular end points — cardiovascular deaths, non-fatal heart attack and non-fatal stroke — occurred in 569 patients (6.5%) in the semaglutide group, compared with 701 patients (8.0%) in the placebo group (hazard ratio 0.80; P<0.001).
Adverse events leading to discontinuation of the trial drug occurred in 1,461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group (P<0.001).
Commenting on the study, Paul Wright, lead cardiac pharmacist at Barts Health NHS Trust, said: “We have seen cardiovascular benefits [of semaglutide] outside of their benefits in diabetes.
“In addition to benefits of weight loss, this trial with longer follow up demonstrates reductions in cardiovascular events.
“A review of the cost effectiveness should be undertaken by NICE to review the previous direction to cap the duration at two years,” Wright added.
On 15 November 2023, a spokesperson for NICE told The Pharmaceutical Journal: “The patient population for this trial falls outside of the remit for our appraisal of semaglutide for managing overweight and obesity.
“We would have to consider it as a new topic and I believe the company would have to apply for an extension to their marketing authorisation,” they added.
On 15 November 2023, a spokesperson for Novo Nordisk, which manufactures semaglutide, told The Pharmaceutical Journal: “Novo Nordisk has filed for a label update of Wegovy® [semaglutide] in the UK, United States and EU to include an indication of reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack or non-fatal stroke) in people with an initial BMI [body mass index] of 27 kg/m2 or greater and established cardiovascular disease.
“A decision is expected in 2024. We can’t provide further information about the duration of treatment at the moment,” they added.