VANCOUVER, May 3, 2016 /CNW/ - Today, pooled results from
the SCALE™ Obesity and Prediabetes, and SCALE™ Diabetes trials were
presented at the 13th International Congress on Obesity
(ICO). This post-hoc analysis demonstrated that at 56 weeks,
people with obesity or who were overweight with comorbidities and
treated with Saxenda®, as an adjunct to a
reduced-calorie diet and increased physical activity, had a
generally consistent effect on weight loss and certain weight
related risk factors across baseline Edmonton Obesity Staging
System (EOSS) scores.1 The EOSS is a disease staging
system, which ranks severity of obesity based on clinical
assessment of weight-related health problems, mental health and
physical function.2
At 56 weeks, greater weight loss was seen in people with obesity
or who were overweight, with or without type 2 diabetes, treated
with Saxenda® compared to placebo consistently across
all baseline EOSS scores.1 Additionally, improvements in
cardiometabolic risk factors (including HbA1c, systolic blood
pressure (SBP) and lipid parameters) and physical function were
greater in those treated with Saxenda® compared to
placebo, again, consistently across all baseline EOSS
scores.1
For this analysis, individuals were assigned a baseline EOSS
score ranging from 0-4, based on the available data on
obesity-related comorbidities. An EOSS score of 0 indicated no
obesity-related comorbidities or risk factors, whereas a score of 4
indicated severe disability due to obesity-related comorbidities or
risk factors.
"Rather than using BMI, the traditional measure of obesity, we
developed the Edmonton Obesity Staging System as a tool to describe
the overall health of people with obesity or who are overweight
with the aim of better supporting weight-management decisions in
clinical practice." said Dr Arya
Sharma, University of Alberta,
Canada and SCALE™ clinical trial investigator. "In this analysis,
we saw that Saxenda® led to weight loss and improvements
of weight-related comorbidities in people with obesity regardless
of the severity of their disease".
Saxenda® was generally well tolerated and observed
side effects were in line with previous liraglutide
trials.3 Across EOSS scores, rates of overall adverse
events were similar. Pulse rate increased with Saxenda®
(1.9–2.6 bpm) vs placebo (-3.9–0.9 bpm; treatment difference
2.0–6.5 bpm, p<0.05).1
About obesity
Obesity is a disease that requires
long-term management. It is associated with many serious health
consequences and decreased life-expectancy.4,5,6
Obesity-related comorbidities include type 2 diabetes, heart
disease, obstructive sleep apnoea (OSA) and certain types of
cancer.5,7,8 It is a complex and multi-factorial disease
that is influenced by genetic, physiological, environmental and
psychological factors.9
The global increase in the prevalence of obesity is a public
health issue that has severe cost implications to healthcare
systems. In 2014, 13 per cent of adults, or approximately 600
million adults, were living with obesity.10 In
Canada, approximately 25 per cent
of adults, equivalent to approximately 6.5 million people, live
with obesity.11 Estimates of the economic burden of
obesity in Canada range from
$4.6 billion to $7.1 billion
annually.12
About the Edmonton Obesity Staging System (EOSS)
The
EOSS ranks people with obesity on a 5-point scale, based on
severity of obesity based on clinical assessment of weight-related
health problems, mental health and quality of life:
- EOSS score '0' = no signs of obesity-related risk factors,
physical symptoms, psychological symptoms, or functional
limitations
- EOSS score '1' = mild obesity-related physical symptoms,
psychological, or functional limitations
- EOSS score '2' = presence of established obesity-related
comorbidities (such as hypertension, type 2 diabetes, sleep apnoea,
osteoarthritis) requiring medical intervention, moderate
psychological symptoms or limitations in activities of daily
living
- EOSS score '3' = significant obesity-related comorbidities with
end-organ damage such as heart failure, stroke, significant
psychological symptoms, functional limitations or impairment of
well-being
- EOSS score '4' = severe end-stage disease from obesity-related
comorbidities, severely disabling psychological symptoms,
functional limitations or impairment of well-being2
About Saxenda®
Saxenda®
(liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1)
analogue with 97 per cent similarity to naturally occurring human
GLP-1, a hormone that is released in response to food
intake.13 Like human GLP-1, Saxenda®
regulates appetite by increasing feelings of fullness and satiety,
while lowering feelings of hunger and prospective food consumption,
thereby leading to reduced food intake. As with other GLP-1
receptor agonists, Saxenda® stimulates insulin secretion
and lowers glucagon secretion in a glucose-dependent
manner.3 These effects can lead to a reduction of
fasting and post-prandial blood glucose. Saxenda® was
evaluated in the SCALE™ (Satiety and Clinical Adiposity –
Liraglutide Evidence) phase 3 clinical trial program.
In Canada, Saxenda®
is indicated as an adjunct to a reduced calorie diet and increased
physical activity for chronic weight management in adult patients
with an initial body mass index (BMI) of 30 kg/m2 or
greater (obese), or 27 kg/m2 or greater (overweight) in
the presence of at least one weight-related comorbidity (e.g.,
hypertension, type 2 diabetes, or dyslipidemia) who have failed a
previous weight management intervention.14
Guidance is given in all labels that treatment with
Saxenda® should be discontinued if a specific threshold
of weight loss has not been achieved after a certain period of
time.
About the SCALE™ clinical development program
Novo
Nordisk's phase 3 development program, called SCALE™, investigates
liraglutide 3 mg for weight management. SCALE™ (Satiety and
Clinical Adiposity – Liraglutide Evidence) consists of four,
placebo-controlled, multinational trials called: SCALE™ Obesity and
Prediabetes, SCALE™ Diabetes, SCALE™ Sleep Apnoea and SCALE™
Maintenance. The trials include more than 5,000 people
who are overweight (BMI ≥27 kg/m2) with comorbidities
such as hypertension, dyslipidaemia, obstructive sleep apnoea
(OSA), or type 2 diabetes, or who have obesity (BMI ≥30
kg/m2), with or without comorbidities. The studies all
involved a reduced-calorie diet and increased physical
activity.
Key results from all trials in the SCALE™ clinical development
program have been published, with further data expected to be
presented and published throughout 2016.
About Novo Nordisk
Novo Nordisk Canada 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 41,000 people 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.
Novo Nordisk Canada employs approximately 280 people at its
head office in Mississauga and
across Canada. The company is
listed as one of Canada's Top 100
Employers for 2016 and has also been awarded the distinction of
being a Top GTA Employer since 2008. For more information,
visit www.novonordisk.ca or follow us on
Twitter @NovoNordiskCA.
References
________________________
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R. The efficacy and safety of liraglutide 3.0 mg for weight
management are similar across baseline edmonton obesity staging
system (eoss) categories: Post hoc analysis at 56 weeks.
International Congress on Obesity (ICO) 2016.
2 Padwal RS, Pajewski NM, Allison DB, Sharma AM. Using
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3 mg) Canada Product Monograph. March
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http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/Saxenda_PM_English.pdf
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SOURCE Novo Nordisk Canada Inc.