Victoza, a GLP-1 receptor analogue, lowered the risk of cardiovascular death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13 per cent when compared to placebo.
The LEADER trial involved 9,430 participants, who were followed for a median of 3.8 years. All the patients had type 2 diabetes and were at a high risk of cardiovascular disease before the study. They were randomly assigned to receive Victoza or placebo in addition to standard care.
As well as having a 13 per cent reduced risk of major cardiovascular events, participants in the Victoza group also had a 22 per cent lower risk of death from heart disease.
Study author Professor Steve Bain said: “Liraglutide is the first GLP-1 therapy that has been shown to significantly reduce the risk of major CV events and represents great progress in our understanding of liraglutide’s clinical profile.
“Given the important link between diabetes and CV complications, it is important to be able to trust that any diabetes treatment prescribed does not add to that risk. The study findings for liraglutide have surpassed our expectations in providing us with a tool that can effectively help to treat patients’ type 2 diabetes and control blood sugar levels, with the additional reassurance of reducing CV risk.”
Krogsgaard Thomsen, Executive Vice president and Chief Science Officer of Novo Nordisk, added: “We are very excited by the LEADER trial results that demonstrate a significant reduction in major cardiovascular events among type 2 diabetes patients treated with Victoza, including all-cause death. For us, this marks the beginning of a new era where our R&D focus will go beyond glucose control.”
Both groups experienced adverse events, but the most common side effect among the Victoza group was gastrointestinal upset, which led to the discontinuation of Victoza in some patients. There were also more cases of pancreatic cancer in the Victoza group, but this was not deemed statistically significant.
The findings were presented at the American Diabetes Association’s 76th Scientific Sessions (ADA 2016) and also published in the New England Journal of Medicine.