Novo Nordisk reports five-year Victoza cardiovascular safety data
pharmafile | March 7, 2016 | News story | Research and Development, Sales and Marketing | Novo Nordisk, Victoza
Novo Nordisk has announced the top-line results from a trial investigating the cardiovascular safety of Victoza (liraglutide [rDNA origin] injection) over a period of up to five years in more than 9,000 adults with type 2 diabetes at high risk of major adverse cardiovascular events.
The LEADER trial compared the addition of Victoza, an injectable prescription medicine that may improve blood sugar in adults with type 2 diabetes, 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 of 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 cardiovascular events demonstrated by Victoza was derived from all three components of the endpoint. The safety profile of Victoza in the LEADER trial was generally consistent with previous liraglutide clinical studies.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, comments: “People with type-2 diabetes generally have a higher risk of experience major adverse cardiovascular events. That’s why we are very excited about the results from LEADER, which showed that Victoza, in addition to helping people with type-2 diabetes control their blood sugar levels, also reduces their risk of major adverse cardiovascular events.”
The detailed results of the trial are set to be presented at the 76th Scientific Sessions of the American Diabetes Association in June 2016. Thomsen adds: “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.”
Sean Murray
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