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

VIENNA, May 24, 2018 /PRNewswire/ --

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
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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.
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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.  
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