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24 May 2018 09:01 CET

Real-world evidence shows clinically meaningful weight loss in people receiving Saxenda®

Vienna, Austria, 24 May 2018 - 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 disease7 that requires long-term management. It is associated with many serious health consequences8 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 disease13 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

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
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Christina Kjær +45 3079 3009 cnje@novonordisk.com

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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/Saxenda_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_GB/document_library/EPAR_-_Product_Information/human/003780/WC500185786.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-adopts-new-policies-on-second-day-of-voting-at-annual-meeting,c9430649. 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.