Real-World Evidence Shows Clinically Meaningful Weight Loss in People Receiving Saxenda®

Vienna (ots/PRNewswire) -

People treated with Saxenda® (liraglutide 3 mg) for weight
management lost an average of 8.1 kg after six months in a real-world
clinical setting, in combination with diet and exercise. The data
were presented this week at both the 25th European Congress on
Obesity (ECO 2018) in Vienna, Austria and the 23rd Annual
International Meeting of the International Society for
Pharmacoeconomics and Outcomes Research (ISPOR 2018) in Baltimore,
US.[1],[2]

This retrospective effectiveness study investigated the impact of
Saxenda® treatment in people with overweight and obesity across six
weight management clinics in Canada. After six months, people treated
with Saxenda® as an adjunct to diet and exercise achieved 7.1% weight
loss from baseline, with 63.4% and 35.2% of people losing >=5% and
>10% of their body weight, respectively.[1],[2] Results from the
real-world study were in line with those observed in the SCALE
clinical trial programme.[3]

"Obesity is a chronic and multifactorial disease, requiring a
range of treatment options to help people achieve and maintain weight
loss," said Dr Sean Wharton of the Wharton Medical Clinic, Toronto,
Canada and lead investigator of this study. "Weight loss of 5 to 10%
can have significant health benefits, including reducing the risk of
developing cardiovascular disease and type 2 diabetes. In this study
we are seeing real-world evidence of people treated with Saxenda®
achieving clinically meaningful weight loss."

People treated with Saxenda® for at least six months also
experienced improvements in cardiometabolic risk factors including
blood glucose levels and systolic blood pressure.[1],[2]

"Saxenda® is an important treatment option for people with obesity
and reflects our commitment to help reduce the impact of obesity and
improve the health of people living with the disease," said Mads
Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk. "It is great to see real-world evidence for
Saxenda®, demonstrating that people are experiencing the benefits of
Saxenda® seen in clinical trials."

Saxenda® was generally well tolerated, with gastrointestinal side
effects being the most frequently reported adverse events.

About the Saxenda® real-world effectiveness study

The study objective was to investigate the real-world clinical
effectiveness of Saxenda® in combination with diet and exercise. This
retrospective study included a total of 311 people who had received
Saxenda® for weight management, of which 167 people received
treatment for at least six months. People whose records were included
in the study had an average body mass index (BMI) of 40.7 kg/m2 and
weight of 114.8 kg at baseline.[1]

About Saxenda®

Saxenda® (liraglutide 3 mg) is a once-daily glucagon-like
peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring
human GLP-1,[4],[5] a hormone that is released in response to food
intake.[6] 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 analogues, Saxenda®
stimulates insulin secretion and lowers glucagon secretion in a
glucose-dependent manner.[4],[5] Saxenda® was evaluated in the SCALE
(Satiety and Clinical Adiposity - Liraglutide Evidence) phase 3a
clinical trial programme.

In Canada, Saxenda® is indicated as an adjunct to a
reduced-calorie diet and increased physical activity for weight
management in adult patients with an initial BMI of >=30 kg/m2
(obese), or >=27 kg/m2 to <30 kg/m2 (overweight) in the presence of
at least one weight-related comorbidity such as dysglycaemia
(prediabetes or type 2 diabetes mellitus), hypertension,
dyslipidaemia or obstructive sleep apnoea.[4]

Guidance is given in the label that treatment with Saxenda® should
be discontinued after 12 weeks on the liraglutide 3.0 mg/day dose, if
patients have not lost at least 5% of their initial body weight.[4]

About obesity

Obesity is a disease[7] that requires long-term management. It is
associated with many serious health consequences[8] and decreased
life expectancy.[9] Obesity-related complications include type 2
diabetes,[8] heart disease,[10] hypertension,[10]
dyslipidaemia,[10]obstructive sleep apnoea,[11] chronic kidney
disease,[12] non-alcoholic fatty liver disease[13] and certain types
of cancer.[14],[15]It is a complex and multifactorial disease that is
influenced by physiological, psychological, environmental,
socio-economic and genetic factors.[16],[17],[18]

The global increase in the prevalence of obesity is a public
health issue that has severe cost implications to healthcare
systems.[19],[20] In 2016, 13% of adults, or approximately 650
million adults, were living with obesity worldwide.[19]

About Novo Nordisk

Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs
approximately 42,700 people in 79 countries and markets its products
in more than 170 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. Wharton S, Liu A, Pakseresht A, et al. Real world clinical
effectiveness of liraglutide 3.0 mg for weight management in
Canada. Abstract (T4PLB2) presented at the 25th European Congress
on Obesity (ECO 2018), Vienna, Austria. 23-26 May 2018.
2. Wharton S, Liu A, Pakseresht A, et al. Real world clinical
effectiveness of liraglutide 3.0 mg for weight management in
Canada. Abstract (PSY10) presented at the 23rd Annual
International Meeting of the International Society for
Pharmacoeconomics and Outcomes Research (ISPOR 2018). Baltimore,
USA. 19-23 May 2018.
3. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, Controlled
Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J
Med. 2015;373:11-22.
4. Novo Nordisk Canada. Saxenda® (liraglutide 3 mg) Canada Product
Monograph. 12 July 2017. Available at: http://www.novonordisk.ca/
content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/S
axenda_PM_English.pdf. Last accessed: May 2018.
5. EMA. Saxenda® (liraglutide 3 mg) summary of product
characteristics. Available at: http://www.ema.europa.eu/docs/en_G
B/document_library/EPAR_-_Product_Information/human/003780/WC5001
85786.pdf. Last accessed: May 2018.
6. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives
of glucagon-like peptide-1 with pharmacokinetic properties
suitable for once daily administration. Journal of Medicinal
Chemistry. 2000;43:1664-1669.
7. American Medical Association. A.M.A Adopts New Policies on Second
Day of Voting at Annual Meeting. Obesity as a Disease. Available
at: http://news.cision.com/american-medical-association/r/ama-ado
pts-new-policies-on-second-day-of-voting-at-annual-meeting,c94306
49. Last accessed: May 2018.
8. Guh DP, Zhang W, Bansback N, et al. The incidence of
co-morbidities related to obesity and overweight: a systematic
review and meta-analysis. BMC Public Health. 2009;9:1-20.
9. Whitlock G, Lewington S, Sherliker P, et al. Body-mass index and
cause-specific mortality in 900 000 adults: collaborative
analyses of 57 prospective studies. Lancet. 2009;373:1083-1096.
10. Poirier P, Giles TD, Bray GA, et al. Obesity and cardiovascular
disease: pathophysiology, evaluation, and effect of weight loss:
an update of the 1997 American Heart Association Scientific
Statement on Obesity and Heart Disease from the Obesity Committee
of the Council on Nutrition, Physical Activity, and Metabolism.
Circulation. 2006;113:898-918.
11. Li C, Ford ES, Zhao G, et al. Prevalence of self-reported
clinically diagnosed sleep apnea according to obesity status in
men and women: National Health and Nutrition Examination Survey,
2005-2006. Prev Med. 2010;51:18-23.
12. Morandi A, Maffeis C. Urogenital complications of obesity. Best
Pract Res Clin Endocrinol Metab. 2013;27:209-218.
13. Angulo P. Nonalchoholic fatty liver disease N Engl J Med.
2009;346:1221-1231.
14. Eheman C, Henley SJ, Ballard-Barbash R, et al. Annual Report to
the Nation on the status of cancer, 1975-2008, featuring cancers
associated with excess weight and lack of sufficient physical
activity. Cancer. 2012;118:2338-2366.
15. Bhaskaran K, Douglas I, Forbes H, et al. Body-mass index and risk
of 22 specific cancers: a population-based cohort study of 5.24
million UK adults. Lancet. 2014;384:755-765.
16. Badman MK, Flier JS. The gut and energy balance: visceral allies
in the obesity wars. Science. 2005;307:1909-1914.
17. Tanaka T. Genome-wide meta-analysis of observational studies
shows common genetic variants associated with macronutrient
intake. Am J Clin Nutr. 2013;97:1395-1402.
18. Woods SC. Understanding the physiology of obesity: review of
recent developments in obesity research. Int J Obes Relat Metab
Disord. 2002;26 Suppl 4:S8-S10.
19. World Health Organization. Obesity and Overweight Factsheet no.
311. Available at:
http://www.who.int/mediacentre/factsheets/fs311/en/. Last
accessed: May 2018.
20. Cawley J, Meyerhoefer C, Biener A, et al. Savings in Medical
Expenditures Associated with Reductions in Body Mass Index Among
US Adults with Obesity, by Diabetes Status. Pharmacoeconomics.
2015;33:707-722.

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