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Significant benefits of weight management drug revealed

Tuesday, 07 July, 2015 


Professor Carel le Roux.

Professor Carel le Roux.

‌Findings of an international study published in the New England Journal of Medicine show that the drug, liraglutide 3.0 mg is beneficial to weight management in obesity when used in combination with diet and increased physical activity.

The SCALE™ obesity and prediabetes study included 3731 obese or overweight participants without diabetes from 191 research sites in 27 countries worldwide. The participants were randomly allocated either liraglutide 3.0 mg or a placebo delivered by injection under the skin once daily for 56 weeks. They were also given lifestyle advice and regularly assessed throughout the study.

Liraglutide is 97% similar to a naturally occurring human hormone called glucagon-like peptide 1 (GLP-1) that is released in response to food intake.1 Like human GLP-1, liraglutide controls food intake by increasing feelings of fullness after eating 2,3.

The study set out to evaluate the percentage of participants who experienced weight change, lost at least 5% or more than 10% of their initial weight. The findings showed that liraglutide 3.0 mg, in combination with diet and increased physical activity, resulted in significantly greater weight loss than diet and physical activity alone.4

After one year, patients treated with liraglutide 3.0 mg had lost 8.4 kg (8%) and those treated with a placebo had lost 2.8 kg (2.6%). The study showed that 33% of patients lost more than 10% of their weight compared to 10% in the placebo group and 14% of patients lost at least 15% of their weight compared to 4% in the placebo group.

Of all participants in the SCALE obesity and prediabetes trial, approximately 60% had prediabetes at baseline, which is a major risk factor for development of type 2 diabetes. After 56 weeks of treatment with liraglutide 3.0 mg, 69% of participants with prediabetes at baseline had reverted to a normal level of glucose in the blood versus 33% in those treated with diet and exercise alone.

The most common side effects with liraglutide 3.0 mg were mild or moderate gastrointestinal events (nausea, vomiting, diarrhoea and constipation). Serious adverse events occurred in in 6% of drug-treated and 5% of placebo-treated participants. In the liraglutide 3.0 mg group, a small number of participants reported gallbladder disorders and pancreatitis.

Professor Carel le RouxUCD School of Medicine based in UCD Diabetes Complications Research Centre and UCD Conway Institute is an obesity specialist and one of the co-authors on the article. 

“In Ireland today, 25% of the population lives with obesity and more than 50% are overweight. These individuals are at risk of a range of conditions that can affect their overall health. Current guidelines recognise that a sustained weight loss of 10% provides significant health benefits for adults with obesity but treatment options to achieve this target are limited”, said Professor le Roux.

The SCALE™ study has shown that this drug treatment could help patients change the biology that has inhibited their best behavioral efforts. It provides clinicians with evidence of the potential benefits of liraglutide 3.0 mg but also the possible side effects to expect. While these may only occur in a small subset of patients, we need to use this drug responsibly and in a way that minimises risk”.

Professor Catherine Godson, Director of the UCD Diabetes Complications Research Centre says, “Obesity is a complex chronic disease of excess fat storage influenced by genetic, physiological, environmental and psychological factors. It has an enormous impact on the people who suffer from the disease and requires long-term management. Liraglutide 3.0 mg should now provide us with a new therapeutic approach for helping patients achieve and maintain a healthier body weight”.

About obesity

Obesity rates have doubled worldwide since 1980 with 106 million people classified as obese in the EU alone. It is the 5th leading cause of death worldwide and places significant economic burden on healthcare systems. Classified by the World Health Organisation as a disease of excess fat storage that impairs health, people with obesity are more likely to suffer other medical conditions or comorbidities like type 2 diabetes, heart disease and hypertension. It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors. Obesity is a disease that requires chronic management.

Journal Reference 
A Randomized Controlled Trial of 3.0 mg of Liraglutide in Weight Management. Xavier Pi-Sunyer, M.D., Arne Astrup, M.D., D.M.Sc., Ken Fujioka, M.D., Frank Greenway, M.D., Alfredo Halpern, M.D., Michel Krempf, M.D., Ph.D., David C.W. Lau, M.D., Ph.D., F.R.C.P.C., Carel W. le Roux, F.R.C.P., Ph.D., Rafael Violante Ortiz, M.D., Christine Bjørn Jensen, M.D., Ph.D., and John P.H. Wilding, D.M., F.R.C.P.; on Behalf of the SCALE Obesity and Prediabetes NN8022-1839 Study Group* NEJM 2015;373(1):11-22| doi:10.1056/NEJMoa1411892

Acronym: SCALE™: Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic people

References
1. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem. 2000; 43(9):1664-1669. 
2. Flint A, Raben A, Ersbøll AK, Holst JJ, Astrup A. The effect of physiological levels of glucagon-like peptide-1 on appetite, gastric emptying, energy and substrate metabolism in obesity. Int J Obes. 2001;25(6):781-92. 
3. van Can J, Sloth B, Jensen CB, Flint A, Blaak EE, Saris WHM. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults [published online ahead of print October 1, 2013]. Int J Obes. doi:10.1038/ijo.2013.162. 
4. Phase 3a data showed liraglutide 3 mg demonstrated significantly greater weight loss compared to placebo in adults with obesity and type 2 diabetes. Data also showed liraglutide 3 mg improved blood glucose control compared to placebo at 56 weeks. [Novo Nordisk press release, 14 June 2014]