Novo Nordisk’s GLP-1 agonist Victoza has become the second drug to show a positive benefit in a large-scale cardiovascular outcomes study involving patients with type 2 diabetes.
The 9,340-patient LEADER trial of Victoza (liraglutide) was presented at the American Diabetes Association (ADA) conference in New Orleans this week and simultaneously published in the New England Journal of Medicine.
The study showed that Novo Nordisk’s drug reduced cardiovascular death, non-fatal myocardial or non-fatal stroke by 13% compared to placebo when added to standard care in patients at high risk of cardiovascular complications.
It is the first drug in the GLP-1 agonist class to show a benefit on outcomes, with the previous ELIXA trial of Sanofi’s rival drug Lyxumia (lixisenatide) suggesting treatment had a neutral effect.
Victoza also reduced all-cause mortality by 15%, and Novo Nordisk’s chief science officer Mads Krogsgaard Thomsen said the data “marks the beginning of a new era where our R&D focus will go beyond glucose control”.
Last year, the results of the EMPA-REG trial of Eli Lilly and Boehringer Ingelheim’s SGLT2 inhibitor Jardiance (empagliflozin) hit the headlines after they showed for the first time conclusively that using drugs to control blood glucose in diabetics can lower risk.
In EMPA-REG trial the reduction in risk was remarkably consistent with LEADER, showing a 14% decline stemming mainly from cutting the rate of cardiovascular death by 38%, and an all-cause mortality reduction of 32%.
Novo Nordisk’s trial also showed the benefit of liraglutide came from reducing cardiovascular death, reducing it by 22%.
Both trials are expected to provide invaluable insights for doctors as they decide which drugs to use second-line after metformin, which remains the first-line drug of choice.
“Our results should give patients and providers comfort that liraglutide can safely improve outcomes beyond the core treatment of type 2 diabetes,” said lead investigator John Buse of the University of North Carolina School of Medicine, who told the conference that the results were “beyond our expectations”.
Interestingly, the LEADER investigators report in the NEJM that they believe the pattern of benefits associated with liraglutide seem different to those seen in EMPA-REG, with the positive impact emerging earlier with empagliflozin.
Victoza has been approved for the treatment of type 2 diabetes in Europe since 2009 and in the US since 2010, with the LEADER trial started shortly after US registration.
The product was Novo Nordisk’s third-biggest product in 2015 with sales of $2.7bn.