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

Bagsværd, Denmark (ots/PRNewswire) -

Findings from a post hoc analysis of the LEADER cardiovascular
(CV) outcomes trial showed that treatment with Victoza® (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® 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 Heart and
Vascular Institute, Kansas City, US and co-chair of the LEADER
Steering Committee. "While the lower incidence of severe
hypoglycaemia with Victoza® 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® (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® 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® treatment vs placebo and non-significant
reductions in non-fatal myocardial infarction and non-fatal
stroke.[2]

About Victoza®

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

Victoza® 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® 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]

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® Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_I
nformation/human/001026/WC500050017.pdf. Last accessed: May 2017.

4. Internal Calculations based on IMS Midas Quantum data. December
2016.

5. FDA. Victoza® 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

Åsa Josefsson

+45-3079-7708

aajf@novonordisk.com
Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Hanna Ögren

+45-3079-8519

haoe@novonordisk.com

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

ots Originaltext: Novo Nordisk A/S
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