Novo Nordisk Says Victoza Significantly Reduces Risk of Major Adverse Cardiovascular Events in Leader Tria; Says Safety Profile of Victoza in Leader Was Generally Consistent With Previous Liraglutide Clinical Studies
Novo Nordisk (NYSE: NVO) today announced the top-line results from the LEADERtrial, which investigated the cardiovascular safety of Victoza(R) (liraglutide) over a period of up to 5 years in more than 9,000 adults with type 2 diabetes at high risk of major adverse cardiovascular events. The trial compared the addition of either Victoza(R) or placebo to standard of care and met the primary endpoint of showing non-inferiority as well as demonstrating superiority, with a statistically significant reduction in cardiovascular risk. The primary endpoint of the study was defined as the composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. The superior reduction of major adverse cardiovascular events demonstrated by Victoza(R) was derived from all three components of the endpoint.
The safety profile of Victoza(R) in LEADER was generally consistent with previous liraglutide clinical studies.
"People with type 2 diabetes generally have a higher risk of experiencing major adverse cardiovascular events. That's why we are very excited about the results from LEADER, which showed that Victoza(R), in addition to helping people with type 2 diabetes control their blood sugar levels, also reduces their risk of major adverse cardiovascular events ", said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "LEADER is the largest and longest Novo Nordisk clinical trial to report to date, and we look forward to sharing the detailed results with the medical community and submitting the findings to the regulatory authorities."
The detailed results are planned to be presented at the 76th Scientific Sessions of the American Diabetes Association in June 2016.
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