BAGSVÆRD, Denmark, June 13, 2017 /PRNewswire/ --
Findings from a post hoc analysis of the LEADER cardiovascular (CV) outcomes trial showed that treatment with Victoza(R) (liraglutide) resulted in similar reductions in the risk of major cardiovascular events in people with type 2 diabetes at high CV risk, regardless of whether or not they experienced an episode of severe hypoglycaemia during the trial. Results were presented yesterday at the American Diabetes Association 77th Scientific Sessions.
For the overall LEADER population, regardless of treatment group, people who experienced a severe hypoglycaemic episode were at a significantly greater risk of major cardiovascular adverse events (CV death, non-fatal heart attack or non-fatal stroke), CV-death or non-CV death. The risk of a CV event was far greater within 60 days of a severe hypoglycaemic episode occurring. At the same time, people treated with Victoza(R) experienced significantly fewer episodes of severe hypoglycaemia when compared to placebo, both in addition to standard of care.
"It appears that patients who experience severe hypoglycaemia are at an increased risk of cardiovascular events," said Steven P. Marso, medical director for Cardiovascular Services at HCA Midwest Heart and Vascular Institute, Kansas City, US and co-chair of the LEADER Steering Committee. "While the lower incidence of severe hypoglycaemia with Victoza (R) could contribute to the observed beneficial effect on major cardiovascular events in LEADER, this new analysis indicates that the results cannot be explained by these differences in hypoglycaemia."
LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term (3.5-5 years) effects of Victoza(R) (liraglutide up to 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major CV events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.
LEADER was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction (heart attack) or non-fatal stroke.
Over a median follow-up of 3.8 years, Victoza(R) significantly reduced the risk of the composite primary endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke by 13% vs placebo. There was a significant 22% reduction in cardiovascular death with Victoza(R) treatment vs placebo and non-significant reductions in non-fatal myocardial infarction and non-fatal stroke.
Victoza(R) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1.
Victoza(R) was approved in the EU in 2009 and is commercially available in more than 90 countries, treating more than 1 million people with type 2 diabetes globally. In Europe, Victoza(R) is indicated for the treatment of adults with type 2 diabetes to achieve glycaemic control as monotherapy, when metformin is considered inappropriate, and in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. In the US, Victoza(R) was approved in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.youtube.com/novonordisk ]
1. Zinman B, Marso SP, Christiansen E, et al. Severe hypoglycemia, cardiovascular outcomes and death - the LEADER experience. Oral presentation 359-OR. 77th Annual Meeting of the American Diabetes Association (ADA), San Diego, USA; 9-13 June 2017.
2. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016; 375:311-322.
3. EMA. Victoza(R) Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf . Last accessed: May 2017.
4. Internal Calculations based on IMS Midas Quantum data. December 2016.
5. FDA. Victoza(R) Prescribing Information. Available at:http://www.novo-pi.com/victoza.pdf. Last accessed: May 2017.
Peter Hugreffe Ankersen
Kasper Veje (US)