Diabetes community welcomes news
that Victoza® reduces the
risk of cardiovascular deaths by 22 per cent
MISSISSAUGA, ON, June 13, 2016 /CNW/ - Novo Nordisk Canada Inc.
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 per cent 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 per cent 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
"The results of this trial are extremely encouraging," said Dr.
Lawrence Leiter, endocrinologist at
St. Michael's Hospital in
Toronto and LEADER investigator.
"The potential to prevent heart attacks, strokes and cardiovascular
deaths in patients with type 2 diabetes who are most at risk is an
exciting advance, and central to successful diabetes care."
All-cause death was significantly reduced by 15 per cent with
Victoza® compared to placebo (95% CI: 0.74; 0.97,
p=0.02). The expanded CV endpoint was significantly reduced by 12
per cent 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 hospitalization, coronary revascularization and
hospitalization for heart
failure.1,2
From a mean baseline of 8.7 per cent (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
"Novo Nordisk is pleased to share these exciting results from
LEADER with the healthcare and broader diabetes community," said
Brian Hilberdink, president, Novo
Nordisk Canada Inc. "This is a tremendous advancement in the
treatment of diabetes as reducing CVD risk has been an ongoing
challenge for physicians. To ensure this important treatment option
is available to more Canadians living with type 2 diabetes, we will
be working closely with provinces across Canada to demonstrate the value of
Victoza®. We've seen positive support from private
insurers and the province of Quebec and we look forward to securing
increased coverage for Victoza® as an option to help
improve the long-term health outcomes for people living with
diabetes, no matter where they live in Canada."
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, randomized,
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 randomized 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®3:
Victoza® is a human glucagon-like peptide-1 (GLP-1)
analog that was approved by Health Canada for once-daily
administration for the treatment of adults with type 2 diabetes to
improve glycemic control in combination with:
- Metformin, when diet and exercise plus maximal tolerated dose
of metformin do not achieve adequate glycemic control.
- Metformin and a sulfonylurea, when diet and exercise plus dual
therapy with metformin and a sulfonylurea do not achieve adequate
glycemic control.
- Metformin and basal insulin, when diet and exercise plus dual
therapy with Victoza® and metformin do not achieve
adequate glycemic control.
Victoza® was launched in the EU in 2009 and is commercially
available in more than 85 countries, including Canada, treating more than 1 million people
with type 2 diabetes globally.4,5
For information about Victoza®, including important
safety information, please visit
http://novonordisk.ca/PDF_Files/our_products/Victoza/Victoza_PM_EN.pdf.
About Novo Nordisk Canada Inc.
Novo Nordisk Canada
Inc. is an affiliate of Novo Nordisk A/S, 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: hemophilia, growth disorders and
obesity. Headquartered in Denmark,
Novo Nordisk employs approximately 40,300 employees in 75
countries, and markets its products in more than 180
countries.
Novo Nordisk's company history has deep Canadian roots, with
company founders Marie and August
Krogh traveling to Toronto
in 1922 to meet with Banting, Best, Collip and MacLeod to discuss
the insulin preparation. Novo Nordisk would become the first
company in Europe to produce
insulin in 1923.
References:
- 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.
- 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.
- Novo Nordisk Canada. Victoza® Product Monograph. April 19, 2016.
- EMA. Victoza® 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.
- Internal Calculations based on IMS Midas Quantum data.
September 2015.
SOURCE Novo Nordisk Canada Inc.