NICE recommends Wegovy® (semaglutide injection) 2.4 mg as the first GLP-1 RA to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in obese or overweight (BMI ≥27 kg/m2) adults with established cardiovascular disease.
This was published after the SELECT trial demonstrated that semaglutide 2.4 mg in addition to standard of care reduced the risk of initial MACE by 20% compared to placebo (hazard ratio, 0.80; 95% CI, 0.72 to 0.90; p < 0.001) and was unrelated to weight loss. During the trial, MACE occurred in 6.5% of participants who received semaglutide, compared to 8.0% of participants who received placebo, representing an absolute risk reduction of 1.5 percentage points.
Overall, the safety profile of semaglutide injection 2.4 mg in SELECT was consistent with previous study experience in STEP 1. Serious adverse events were lower in the semaglutide group compared with placebo (33.4% vs 36.4%; p < 0.001). Adverse events leading to treatment discontinuation were more common with semaglutide injection 2.4 mg vs. placebo (16.6% vs. 8.2%; p < 0.001) and were primarily due to gastrointestinal symptoms.
Wegovy® will be introduced into existing cardiovascular care pathways, allowing clinicians to consider semaglutide as an alternative treatment option alongside standard of care for the secondary prevention of cardiovascular events in those who are overweight or obese (BMI ≥ 27 kg/m2). NICE assessed that in this patient population: “Semaglutide offers benefits and value for money so it can be used routinely across the NHS.”.
Today’s NICE recommendation for Wegovy is a significant step forward for people living with pre-existing cardiovascular disease or being overweight or obese. This means that clinicians in the UK now have access to a further treatment that NICE has recognized as cost-effective – the first and only GLP-1 receptor agonist proven to reduce the risk of heart attack, stroke and cardiovascular death in this high-risk population. ”
Sebnem Avsar Tuna, General Manager, Novo Nordisk UK
Professor Derek Connolly, consultant preventive cardiologist and Vice Chancellor’s Professorial Fellow for Healthcare Research at Aston University, consultant cardiologist in Birmingham and member of the Primary Care Cardiovascular Society Council, said:
“Cardiovascular disease remains one of the leading causes of death in the UK, and people who have already experienced a cardiovascular event continue to face a significant risk of further heart attack or stroke. For clinicians, having an alternative treatment supported by robust outcome evidence is an important additional option to help reduce mortality and the burden of heart attack and stroke. ”
More than eight million people in the UK have a heart or circulatory disease, and these diseases account for around a quarter of deaths each year, or around 170,000 people a year. Although survival rates after heart attack and stroke have improved, the overall number of people living with cardiovascular disease is expected to continue to increase as the population ages.
Novo Nordisk is exploring how best to support the NHS in implementing NICE’s recommendations, with input from NHS clinical experts and organizations.
