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

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Novo Nordisk today announced that Victoza® (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® 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® 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® 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®
compared to placebo (95% CI: 0.74; 0.97, p=0.02). The expanded CV
endpoint was significantly reduced by 12% with Victoza® 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® 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® 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®, 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® and the placebo groups (62.3% vs 60.8,
respectively). The most common adverse events leading to the
discontinuation of Victoza® were gastrointestinal events. The
incidence of pancreatitis was non-significantly lower in the Victoza®
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® (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®

Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1)
analogue with an amino acid sequence 97% similar to endogenous human
GLP-1.

Victoza® 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® 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® 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® EU summary of product characteristics. April
2016. Available at: http://ec.europa.eu/health/documents/community-re
gister/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® US prescribing information. April 2016. Available
at: http://www.novo-pi.com/victoza.pdf. Last accessed: June 2016.

ots Originaltext: Novo Nordisk A/S
Im Internet recherchierbar: http://www.presseportal.de