Victoza(R) lowered the progression of kidney damage in adults with type 2 diabetes at high CV risk

PR65765

MUNICH, Sept. 16 /PRNewswire=KYODO JBN/ --

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    Novo Nordisk today announced that the progression of kidney damage was

significantly lower with Victoza(R) treatment vs placebo, as measured by

urinary albumin creatinine ratio, both added to standard of care in 9,340

adults with type 2 diabetes at high cardiovascular (CV) risk. Similar

significant results were observed between Victoza(R) and placebo across

subgroups (with no, mild or moderate renal impairment).[1] The results were

presented today at the 52nd Annual Meeting of the European Association for the

Study of Diabetes (EASD) 2016.[1]

    New onset or worsening kidney disease was part of a pre-specified secondary

endpoint in the landmark LEADER CV outcomes trial. The overall risk reduction

of 22% was primarily driven by the component of new onset of persistent

macroalbuminuria (high levels of a protein called albumin found in the urine),

which occurred significantly less (26%) in adults treated with Victoza(R) vs

placebo.[1]

    "Kidney disease is one of the more common long-term complications of type 2

diabetes, affecting up to 40% of adults living with this disease," said Dr

Johannes Mann, LEADER investigator and Professor of Medicine, Dept. of

Nephrology & Hypertension, University of Erlangen-Nuremberg, Germany. "These

findings are clinically relevant as they indicate that Victoza(R) may have the

potential to reduce the risk of kidney disease in adults with type 2 diabetes

at high cardiovascular risk."

    Furthermore, a secondary analysis on hospitalisations for heart failure

(HF) demonstrated that Victoza(R) did not increase the risk of hospitalisation

for HF in adults with type 2 diabetes and a history of HF vs placebo. In a

pre-specified secondary analysis for LEADER, Victoza(R) reduced

hospitalisations for HF by 13% vs placebo across all adults with or without a

history of HF at baseline.[1]

    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.[2]

    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

cardiovascular events.[2] Standard of care was comprised of lifestyle

modifications, glucose-lowering treatments and cardiovascular medications.[3]

    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]

    Kidney disease was assessed by the composite renal outcome, defined as:

high levels of a protein called albumin found in the urine (new onset of

persistent macroalbuminuria); kidney filtration function (persistent doubling

of serum creatinine); need for dialysis (continuous renal replacement therapy);

or death due to kidney disease.[2]

    About kidney disease and type 2 diabetes

    Diabetes significantly increases the risk of developing diabetic

nephropathy, which is the leading cause of end-stage kidney disease (or kidney

failure). Diabetic nephropathy affects 30-40% of those with diabetes and males

with type 2 diabetes have a six-fold increased risk of developing this

condition compared to those without type 2 diabetes. Furthermore, the presence

of diabetic nephropathy is known to be a significant risk factor for

cardiovascular disease.[4]

    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 approved in the EU in 2009[5] and is commercially available

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

diabetes globally.[6] 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.[5] 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.[7]

    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 42,300 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

    Asa Josefsson

    +45 3079 7708

    aajf@novonordisk.com

    Investors:

    Peter Hugreffe Ankersen

    +45 3075 9085

    phak@novonordisk.com

    Melanie Raouzeos

    +45 3075 3479

    mrz@novonordisk.com

    Hanna Ogren

    +45 3079 8519

    haoe@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. Scientific Sessions at the 52nd

Annual Meeting of the European Association for the Study of Diabetes (EASD)

2016. 15 September 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; 375:311-322.

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

cardiovascular outcomes in type 2 diabetes. Supplementary Information. New

England Journal of Medicine 2016; 375:311-322.

    4) Gallagher H, Suckling RJ. Diabetic nephropathy: where are we on the

journey from pathophysiology to treatment? Diabetes, Obesity and Metabolism

2016; 18:641-647.

    5) EMA. Victoza(R) EU 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: September 2016.

    6) Internal Calculations based on IMS Midas Quantum data. March 2016.

    7) FDA. Victoza(R) US prescribing information. April 2016. Available

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

SOURCE: Novo Nordisk