A weight-loss jab can reduce the risk of a heart attack or stroke by 20 per cent, according to “exciting” trial results.
Pharmaceutical company Novo Nordisk conducted a five-year study of semaglutide, sold under the brand name Wegovy, which showed even more benefits than already known.
Researchers found the risk of heart attack or stroke in obese patients given a 2.4mg once-weekly dose of Wegovy, alongside standard care for the prevention of heart attacks or stroke, reduced by a fifth compared with those given a placebo drug.
It is the third major benefit of semaglutide – also sold under the brand names Ozempic and Rybelsus – which has already been found to be an effective treatment for obesity and type 2 diabetes.
The UK’s medicines regulator authorised Wegovy in September 2021 and the National Institute for Health and Care Excellence announced in March that the drug could be given to obese patients with at least one condition such as high blood pressure.
However, its launch on the NHS has been delayed due to soaring demand for weight loss jabs. Semaglutide’s popularity has led to shortages which look set to last into next year and have seen diabetes patients unable to access vital supplies as people buy the drug “off label” in a bid to lose weight.
Novo Nordisk has been reluctant to announce a date for when it will become available until it is confident it will be able to meet demand, despite patient groups hoping to get access to it by the end of the year. The results of the trial are likely to accelerate the drug’s use by the NHS. About four million people in England are expected to be eligible for the drug on the NHS when it launches.
As part of its Select trial, Novo Nordisk recruited 17,604 adults over the age of 45 from across 41 countries. Each patient had a body mass index (BMI) of 27 or over and established cardiovascular disease, with no history of diabetes.
Analysis: Exciting breakthrough, but patients may have to wait
Anyone who invested a significant amount of money in Novo Nordisk two years ago will be even happier today.
The company’s large study revealed its highly effective obesity drug Wegovy also had a clear cardiovascular benefit and resulted in another surge in the Danish drugmaker’s share price – up 150 per cent in the past two years.
However, Britons wanting access to the “gamechanging” drug will have a little longer to celebrate as Wegovy is still not available on the NHS despite being authorised by the UK’s medicines regulator in September 2021.
The drugs watchdog then issued guidelines this year recommending Wegovy be prescribed to diabetics who have a particular BMI (usually 30 and over) and at least one weight-related health condition as an option for weight management, but soaring demand for weight loss drugs saw Novo Nordisk delay Wegovy’s UK launch indefinitely.
Armed with its new trial findings, the company expects to file for regulatory approvals to expand the use of the drug to protect against major adverse cardiovascular events (MACEs) in the US and the EU later this year.
It is not yet clear when the drug could be approved for such use in the UK and the company declined to comment on the issue.
Scientists who were not involved in the drug welcomed the results – companies normally run their own trials looking at drugs they have developed – although they cautioned that these are only the “headline findings” of the trial and that more detail is needed.
That will come following the peer-review process of the trial results and give a fuller picture of the potential of the drug.
By Paul Gallagher
Martin Holst Lange, executive vice president for development at Novo Nordisk, said: “People living with obesity have an increased risk of cardiovascular disease, but to date there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death.
“Therefore, we are very excited about the results from Select showing that semaglutide 2.4mg reduces the risk of cardiovascular events. Select is a landmark trial and has demonstrated that semaglutide 2.4mg has the potential to change how obesity is regarded and treated.”
Professor Stephen O’Rahilly, director of the MRC Metabolic Diseases Unit at the Institute of Metabolic Science, University of Cambridge, said the results “have been long awaited and do not disappoint”.
He said: “Simply put, a drug which acts to reduce body weight by targeting appetite, if taken long term by people who are overweight or obese, significantly reduces their risk of serious cardiovascular events, such as heart attack.
“The obvious conclusion of these findings is that we should view obesity as a medical condition, like high blood pressure, where effective and safe drug therapy can contribute to reducing serious adverse health outcomes.”
Novo Nordisk expects to file for regulatory approvals to expand the use of the drug to protect against major adverse cardiovascular events in the US and the EU later this year.
Scientists who were not involved in the drug welcomed the results – although they cautioned that these are only “headline findings” of the trial and that more detail is needed to give a fuller picture of the potential of the drug.
“The top line results are exciting as preventing heart attacks and stroke with a drug that also lowers weight is very important for many patients,” said Professor Naveed Sattar, of Glasgow University.
“More details are needed on the trials to give it proper consideration, including examination of safety aspects… The one thing to caution is we do not know to what extent the weight loss effects of semaglutide – as opposed to its other direct effects on blood vessels or the heart – account for the 20 per cent reduction in cardiovascular events.
“More data are needed to try to work this out. For now, however, this is a good result for patients, especially as progressively more are living with obesity and cardiovascular disease.”
Professor Stephen O’Rahilly, of the University of Cambridge, said: “The results from this trial have been long awaited and do not disappoint. Simply put, a drug which acts to reduce body weight by targeting appetite, if taken long term by people who are overweight or obese, significantly reduces their risk of serious cardiovascular events, such as myocardial infarction (heart attack).”
Dr Simon Cork, senior lecturer in physiology at Anglia Ruskin University, added: “Whilst the results of the trial still need to be confirmed through careful peer review, they demonstrate the urgent need for patients living with obesity to be offered this effective and safe drug to prevent future disease.
“Obesity and its associated health impacts cost the NHS over £ 6bn per year. The results of the trial show that effective and long term support with losing weight with Wegovy, the results of which are unattainable for most people living with obesity to achieve through diet and exercise alone, results in significant improvements in health outcomes. This will not only provide significant financial savings for health bodies, but provide people with a greater quality of life.”
Health Secretary Steve Barclay, said: “The next generation of obesity drugs have the potential to help patients lose significant amounts of weight and reduce obesity related conditions, helping ease pressure on the NHS and cut waiting times – one of the government’s five priorities.
“But it’s vital they’re used alongside diet, physical activity, and wider behavioural support to help minimise weight regain.
“We’ve announced a two-year pilot, backed by £40 million, to give more eligible patients living with obesity access to the newest and most effective obesity drugs when they launch in the UK.”
A spokesman for Novo Nordisk said: “We are working to make it (Wegovy) available in the UK as soon as possible.”
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