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LEADER trial leads the way in cardiovascular safety

20 June 2016

Liraglutide has cardiovascular benefits

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The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) now require proof that a glucose-lowering drug for Type 2 diabetes doesn’t cause cardiovascular harm. 

As a result, several licensed drugs have been undergoing large cardiovascular safety studies. Last year, theEMPA-REG trialreported that empagliflozin (an SGLT-2 inhibitor) significantly lowered the risk of deaths relating to cardiovascular complications. 

Looking forward, theEXSCEL trialis currently testing the safety of exenatide and theGRADE studyis comparing the benefits of several different types of diabetes drug.  

Last week, Novo Nordisk announced that liraglutide (or Victoza) significantly reduces the risk of cardiovascular complications in people with Type 2 diabetes, publishing the results in theNew England Journal of Medicine.

What’s liraglutide?

Liraglutide is a once daily injectable treatment that acts to help people with Type 2 diabetes achieve good control of their blood glucose levels, by stimulating the release of insulin when levels get too high, and reduces appetite. This type of drug is known as anincretin mimetic, or GLP-1 receptor agonist.  

The National Institute for Health and Clinical Excellence (NICE)approved the use of liraglutide as a treatment option in 2010

Reducing the risk of cardiovascular complications

The LEADER (Liraglutide Effect and Action in Diabetes – Evaluation of Cardiovascular Outcome Results) trial tested the effects of liraglutide in 9,340 people with Type 2 diabetes, recruited across 32 countries, compared to a dummy drug. The researchers were interested in the effect that liraglutide had on the risk of cardiovascular problems in people with Type 2 diabetes, to ensure that the treatment was safe. 

At the end of the five-year trial, the team found that there was a 13 percent reduction in the number of cardiovascular problems, compared to those taking the dummy drug. They also found that there was a 22 percent reduction in the number of deaths caused by a cardiovascular problem. 

“It will help in the international fight against diabetes complications”

Professor John Petrie, a member of the LEADER Global Expert Panel based at the University of Glasgow, was very pleased with the results: “This is one of the best pieces of news people with Type 2 diabetes have had in the last 20 years. [Liraglutide] is a powerful drug for lowering blood sugar and also helps with weight reduction – but it has to be taken by daily injections, so is more expensive than most treatments by mouth. For this reason, it has mainly been used when other treatments stop working. 

“The LEADER trial shows without any doubt that liraglutide prevents heart attacks, strokes and early death in people with Type 2 diabetes at risk. 

“Over the past five years, hundreds of people with Type 2 diabetes in the UK have taken part in LEADER. They can be really proud of their role in contributing to this strongly positive result. It will change treatment guidelines and help in the international fight against diabetes complications.”

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