Health Canada approves Victoza® as the first and only GLP-1 receptor agonist to reduce the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease. Français
- Cardiovascular disease (CVD) is the leading cause of death for people with T2D, who are at a 2 – 4 times higher risk of CVD than the general population. 1
- People with diabetes are over 3 times more likely to be hospitalized with cardiovascular disease. 1
- 80% of Canadians with diabetes die from a heart attack or stroke.2
MISSISSAUGA, ON, Nov. 21, 2017 /CNW/ - Novo Nordisk announced today that Health Canada has approved a product monograph update for Victoza® (liraglutide). Victoza® is now approved to reduce the incidence of cardiovascular (CV) death in patients with type 2 diabetes mellitus and established CVD when added to diet, exercise, and the current standard of care therapy.3
High blood glucose is one risk factor for heart attack or stroke, but people with diabetes often have a number of other risk factors. These include being overweight (especially if they have additional fat around the stomach), sedentary lifestyles, high blood pressure and high cholesterol. People who smoke or have a family history of heart disease or stroke are at even higher risk.4
The product monograph update for Victoza® reflects the Canadian Diabetes Association Clinical Practice Guidelines and is supported by results from the LEADER trial, which examined the long-term effects of Victoza® in patients with type 2 diabetes and established CVD. In the LEADER trial, Victoza® (liraglutide up to 1.8 mg; median daily dose 1.78 mg) statistically significantly reduced the risk of CV death, non-fatal myocardial infarction (heart attack) and non-fatal stroke by 13 per cent versus placebo. The overall risk reduction was derived from a statistically significant 22 per cent reduction in cardiovascular death with Victoza® treatment versus placebo and non-significant reductions in non-fatal myocardial infarction and non-fatal stroke.5,6
"Diabetes rates in Canada have almost doubled over the past decade," explains Dr. Jan Hux, Chief Science Officer, Diabetes Canada. "People with diabetes may develop heart disease 10 to 15 years earlier than individuals without diabetes. It is critically important that people living with diabetes are provided with solutions to help prevent the onset and consequences of diabetes, including cardiovascular disease."
"LEADER is a landmark study which has provided robust evidence that liraglutide can reduce the risk of cardiovascular disease in adults with diabetes and a history of heart disease" said Dr. Lawrence Leiter, Professor of Medicine at the University of Toronto, and National Leader of the trial. "Our Diabetes Canada guidelines highlight the fact that the use of medications with evidence of cardiovascular benefit should be a priority in such patients"
About Victoza®
Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97 per cent similar to endogenous human GLP-1. Victoza® is approved by Health Canada for the treatment of adults with insufficiently controlled type 2 diabetes together with diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, and in addition to other medicinal products for the treatment of type 2 diabetes.3
Victoza® is also approved by Health Canada to reduce the incidence of CV death in patients with type 2 diabetes mellitus and established CVD when added to diet, exercise and the current standard of care therapy.3
Victoza® was launched in the EU in 2009 and is commercially available in more than 85 countries, including Canada, treating more than 1 million people with type 2 diabetes globally.7,8
For information about Victoza®, including important safety information, please visit
http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/victoza-product-monograph.pdf
About the LEADER trial
LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term (3.5–5 years) effects of Victoza® (liraglutide) compared to placebo, both in addition to standard of care, in patients with type 2 diabetes and established CVD. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.5
The landmark LEADER trial was initiated in September 2010 and randomised 9,340 patients with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal heart attack or non-fatal stroke.5
About Novo Nordisk
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 obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 41,700 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
References
| 1. |
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabetes 2013;37(suppl 1):S1-S212. |
| 2. |
Canadian Diabetes Association. Diabetes: Canada at the tipping point. Available at https://www.diabetes.ca/CDA/media/documents/publications-and-newsletters/advocacy-reports/canada-at-the-tipping-point-english.pdf. Accessed October 2017. |
| 3. |
VICTOZA Product Monograph. Novo Nordisk Canada Inc., November 17, 2017. http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/victoza-product-monograph.pdf |
| 4. |
Diabetes Canada. Heart Disease & Stroke. Available at https://www.diabetes.ca/diabetes-and-you/complications/heart-disease-stroke. Accessed October 2017 |
| 5. |
Marso SP, et al. N Eng J Med 2016;375:311-22. |
| 6. |
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Can J Diabetes 2016;40:484-86. |
| 7. |
EMA. Victoza® EU summary of product characteristics. September 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf. Last accessed: 18 October 2016. |
| 8. |
Internal Calculations based on IMS Midas Quantum data. September 2015. |
SOURCE Novo Nordisk Canada Inc.
Media: Kate Hanna, 905-629-6612, [email protected]
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