Novo publishes positive Victoza® results
The GLP-1 receptor analogue Victoza® (liraglutide) significantly reduced the risk of major cardiovascular events and death in adults with type 2 diabetes in the LEADER trial, Novo Nordisk has announced.
The drug significantly reduces the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13 per cent vs placebo (95 per cent confidence interval [CI]: 0.78; 0.97, p=0.01), in addition to standard of care in 9,340 adults with type 2 diabetes at high CV risk.
Superior reduction of major CV events
The main results of the LEADER trial were presented yesterday at the American Diabetes Association’s 76th Scientific Sessions (ADA 2016) and also published in the New England Journal of Medicine. Victoza® is the only approved GLP-1 receptor agonist to demonstrate a superior reduction of major CV events vs placebo, both in addition to standard of care, in a cardiovascular outcomes trial.
There was a significant 22 per cent reduction in cardiovascular death with Victoza® treatment vs placebo (95 per cent CI: 0.66; 0.93, p=0.007) and reductions in non-fatal myocardial infarction (HR=0.88, 95 per cent CI: 0.75; 1.03, p=0.11) and non-fatal stroke (HR=0.89, 95 per cent CI: 0.72; 1.11, p=0.30).
The study findings for liraglutide have surpassed our expectations
Professor Steve Bain is the UK LEADER trial National Leader and Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Unit, Wales.
He 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.”
All-cause death was significantly reduced by 15 per cent with Victoza® compared to placebo (95 per cent CI: 0.74; 0.97, p=0.02). The expanded CV endpoint was significantly reduced by 12 per cent with Victoza® compared to placebo (95 per cent CI: 0.81; 0.96, p=0.005). The expanded CV endpoint included the three components of the primary endpoint in addition to unstable angina leading to hospitalisation, coronary revascularisation and hospitalisation for heart failure.
From a mean baseline of 8.7 per cent (both groups), there was a greater reduction in HbA1c with Victoza® vs placebo, in addition to standard of care, at three years (estimated treatment difference [ETD]: -0.40 per cent, 95 per cent CI: -0.45; -0.34). Weight loss was also sustained over three years with Victoza® treatment vs placebo (ETD: -2.3 kg, 95 per cent CI: – 2.5; -2.0). Mean baseline weight was 91.9 kg and 91.6 kg, respectively.
‘Beginning of a new era’
Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “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.”
The proportion of adults experiencing adverse events was similar between the Victoza® and the placebo groups (62.3 per cent vs 60.8 per cent, respectively). The most common adverse events leading to the discontinuation of Victoza® were gastrointestinal events. The incidence of pancreatitis was non-significantly lower in the Victoza® group than in the placebo group.