The National Institute for Health and Care Excellence (NICE) has recommended that a weekly injection of semaglutide is given to more than a million people to help prevent heart attacks and strokes.
This latest recommendation from NICE is underpinned by several years of research supported by the NIHR.
Semaglutide, which is sold under the brand name Wegovy, is already available through the NHS for some people living with obesity. It is also offered under the brand name Ozempic to treat type 2 diabetes.
Now people who are not obese but overweight – with a body mass index (BMI) score of 27 and above – and at risk of serious cardiovascular events will also be eligible for the weekly injections.
The burden of heart disease
Heart and circulatory disease remain one of the leading causes of early death and ill health in England. Each year in the UK, there are around 100,000 hospital admissions due to heart attacks. Another 100,000 people experience a stroke and around 350,000 people live with peripheral arterial disease.
People who have already had one of these events face a significantly higher risk of another and are usually prescribed a number of medicines to reduce that.
Although semaglutide (Wegovy) is widely known as a weight loss treatment, the NICE recommendation is specifically about preventing heart attacks and strokes. The injection is an additional treatment, which will be offered on top of the medicines people are already taking such as statins, and alongside a reduced-calorie diet and increased physical activity for those at high risk of another serious event.
How NIHR research underpins this work
Research funded or supported by the NIHR has contributed to the body of evidence for the clinical uses of semaglutide. This includes aspects of weight management, type 2 diabetes and cardiovascular disease.
In Novo Nordisk’s SELECT trial, 17,604 people who took semaglutide alongside their existing cardiovascular medicines – including cholesterol-lowering drugs such as statins – were 20% less likely to have a serious cardiovascular event than those who took a placebo alongside the same medicines.
SELECT was supported by NIHR Leicester Biomedical Research Centre (BRC) and NIHR Exeter Clinical Research Facility, and delivered through the NIHR Clinical Research Network (CRN, now the Research Delivery Network), with over 1,000 participants recruited to 44 sites.
The NIHR also supported the Novo Nordisk-funded STEP trials (STEP 1, STEP 2, STEP-HFpEF and STEP-HFpEF DM), which found that semaglutide consistently induced significant weight loss (~10–15%) and improved physical symptoms and functional capacity in patients with obesity, type 2 diabetes, and heart failure with preserved ejection fraction.
The STEP trials were delivered through the NIHR CRN and Leicester BRC, and some participant recruitment took place through the Be Part of Research service. Professor Melanie Davies CBE, Director of the NIHR Leicester BRC, was a co-author on the landmark papers for STEP-HFpEF and STEP-HFpEF DM.
Among other semaglutide trials, the NIHR has also supported PIONEER 6, ESSENCE, EVOKE and EVOKE Plus.
Further research relating to semaglutide is ongoing across various NIHR programmes, schemes and initiatives, with a focus on uses of semaglutide for obesity and weight management. This includes:
- an adaptive trial consortium
- a study on use of obesity medications outside hospital settings
- supporting treatment in cardiovascular disease
- studies on digital and behavioural tools to improve outcomes of weight management interventions
Helen Knight, Director of Medicines Evaluation at NICE, said:
“We know that people who have already had a heart attack or stroke are living with real fear that it could happen again. Today’s decision gives thousands of people in that situation an extra layer of protection, on top of the medicines they are already taking.
“Our role is to help practitioners get the best care to people while ensuring value for the taxpayer, and we are confident this rigorous, transparent recommendation strikes the right balance between clinical effectiveness and the best use of limited NHS resources.”