New LEADER Analysis Shows Victoza(R) Reduces Cardiovascular Risk in People With Type 2 Diabetes Regardless of Severe Hypoglycaemia Events

PR68873

BAGSVAERD, Denmark, June 13 /PRNewswire=KYODO JBN/ --

    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.[1]

    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.[1]

    "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 Health 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."

    About LEADER  

    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.[2]

    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.[2]

    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.[2]

    About Victoza(R)  

    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[3] and is commercially available

in more than 90 countries, treating more than 1 million people with type 2

diabetes globally.[4] 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.[3] 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.[5]

    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 ]  

    References  

    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.

     Further information

    Media:

    Katrine Sperling

    +45-4442-6718

    krsp@novonordisk.com

    Asa Josefsson

    +45-3079-7708

    aajf@novonordisk.com

    Investors:

    Peter Hugreffe Ankersen

    +45-3075-9085

    phak@novonordisk.com

    Hanna Ogren

    +45-3079-8519

    haoe@novonordisk.com

    Anders Mikkelsen

    +45-3079-4461

    armk@novonordisk.com

    Kasper Veje (US)

    +1-609-235-8567

    kpvj@novonordisk.com

SOURCE: Novo Nordisk