Victoza(R) significantly reduced the risk of major cardiovascular events and death in adults with type 2 diabetes in the LEADER trial

PR64773

NEW ORLEANS, June 14, 2016 /PRNewswire=KYODO JBN/ --

    This material is intended for global medical media only.

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    Novo Nordisk today announced that Victoza(R) (liraglutide) significantly

reduced the risk of the composite primary endpoint of cardiovascular (CV)

death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by

13% vs placebo (95% confidence interval [CI]: 0.78; 0.97, p=0.01), when added

to standard of care in 9,340 adults with type 2 diabetes at high CV risk. The

main results of the LEADER trial were presented today at the American Diabetes

Association's 76th Scientific Sessions (ADA 2016) and also published in the New

England Journal of Medicine.[1],[2] Victoza(R) is the only approved GLP-1

receptor agonist to demonstrate a superior reduction of major CV events vs

placebo, both on top of standard of care, in a cardiovascular outcomes trial.

    There was a significant 22% reduction in cardiovascular death with

Victoza(R) treatment vs placebo (95% CI: 0.66; 0.93, p=0.007) and reductions in

non-fatal myocardial infarction (HR=0.88, 95% CI: 0.75; 1.03, p=0.11) and

non-fatal stroke (HR=0.89, 95% CI: 0.72; 1.11, p=0.30).[1],[2]

    "These findings are exciting, as it demonstrates that Victoza(R) can

improve outcomes beyond glucose reduction and weight loss by helping to avoid

cardiovascular complications and death in people with type 2 diabetes," said Dr

John Buse, chairman of the LEADER Steering Committee and chief of Endocrinology

and director of the Diabetes Care Centre at the University of North Carolina

School of Medicine. "Type 2 diabetes treatments that can also reduce

cardiovascular risk are important since cardiovascular disease is the leading

cause of death worldwide in this patient population."

    All-cause death was significantly reduced by 15% with Victoza(R) compared

to placebo (95% CI: 0.74; 0.97, p=0.02). The expanded CV endpoint was

significantly reduced by 12% with Victoza(R) compared to placebo (95% CI: 0.81;

0.96, p=0.005). The expanded CV endpoint included the three components of the

primary endpoint in addition to unstable angina leading to hospitalisation,

coronary revascularisation and hospitalisation for heart failure.[1],[2]

    From a mean baseline of 8.7% (both groups), there was a greater reduction

in HbA1c with Victoza(R) vs placebo, both on top of standard of care, at three

years (estimated treatment difference [ETD]: -0.40%, 95% CI: -0.45; -0.34).

Weight loss was also sustained over three years with Victoza(R) treatment vs

placebo (ETD: -2.3 kg, 95% CI: -2.5; -2.0). Mean baseline weight was 91.9 kg

and 91.6 kg, respectively.[1],[2]

    "We are very excited by the LEADER trial results that demonstrate a

significant reduction in major cardiovascular events among type 2 diabetes

patients treated with Victoza(R), including all-cause death," said Mads

Krogsgaard Thomsen, executive vice president and chief science officer of Novo

Nordisk. "For us, this marks the beginning of a new era where our R&D focus

will go beyond glucose control."

    The proportion of adults experiencing adverse events was similar between

the Victoza(R)  and the placebo groups (62.3% vs 60.8, respectively). The most

common adverse events leading to the discontinuation of Victoza(R) were

gastrointestinal events. The incidence of pancreatitis was non-significantly

lower in the Victoza(R) group than in the placebo group.[1],[2]

    About LEADER

    LEADER was a multicentre, international, randomised, double-blind,

placebo-controlled trial investigating the long-term 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 cardiovascular

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 that were followed for 3.5-5 years. The

primary endpoint was the first occurrence of a composite cardiovascular outcome

comprising cardiovascular death,  non-fatal myocardial infarction or non-fatal

stroke.[2]

    About Victoza(R)

    Victoza(R) (liraglutide) 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 launched in the EU in 2009 and is commercially available in

more than 85 countries, treating more than 1 million people with type 2

diabetes globally.[3],[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]

    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 other

serious chronic conditions: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in

75 countries and markets its products in more than 180 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 ]

Further information:

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Ken Inchausti (US)

+1-609-786-8316

kiau@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Melanie Raouzeos

+45-3075-3479

mrz@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

     _______________________

    References

    1. Results of the liraglutide effect and action in diabetes - evaluation of

cardiovascular outcome results (LEADER) trial. Symposium 3-CT-SY24 at the 76th

Scientific Sessions of the American Diabetes Association (ADA). 13 June 2016.

    2. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and

cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine.

2016; In Press. DOI: 10.1056/NEJMoa1603827.

    3. EMA. Victoza(R) EU summary of product characteristics. April 2016.

Available at:

http://ec.europa.eu/health/documents/community-register/2016/20160526135038/anx_135038_en.pdf

. Last accessed: 11 June 2016.

    4. Internal Calculations based on IMS Midas Quantum data. September 2015.

    5. FDA. Victoza(R) US prescribing information. April 2016. Available at:

http://www.novo-pi.com/victoza.pdf. Last accessed: June 2016.

SOURCE: Novo Nordisk