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

PR73680

VIENNA, May 22, 2018 /PRNewswire=KYODO JBN/ --

     People treated with Saxenda(R) (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(R) treatment in people with overweight and obesity across six weight

management clinics in Canada. After six months, people treated with Saxenda(R)

as an adjunct to diet and exercise achieved 7.1% weight loss from baseline,

with 63.4% and 35.2% of people losing greater than or equal to5% 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(R) achieving clinically meaningful weight loss."

    People treated with Saxenda(R) for at least six months also experienced

improvements in cardiometabolic risk factors including blood glucose levels and

systolic blood pressure.[1],[2]

    "Saxenda(R) 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(R),  demonstrating that people are

experiencing the benefits of Saxenda(R) seen in clinical trials."

    Saxenda(R) was generally well tolerated, with gastrointestinal side effects

being the most frequently reported adverse events.

    About the Saxenda(R) real-world effectiveness study

    The study objective was to investigate the real-world clinical

effectiveness of Saxenda(R) in combination with diet and exercise. This

retrospective study included a total of 311 people who had received Saxenda(R)

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(R)

    Saxenda(R) (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(R) 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(R)

stimulates insulin secretion and lowers glucagon secretion in a

glucose-dependent manner.[4],[5] Saxenda(R) was evaluated in the SCALE (Satiety

and Clinical Adiposity - Liraglutide Evidence) phase 3a clinical trial

programme.

    In Canada, Saxenda(R) 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 greater than or equal to30 kg/m2 (obese), or greater than or

equal to27 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(R) 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(R) (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(R) (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.

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SOURCE: Novo Nordisk