GOTHENBURG, Sweden, June 2, 2016 /PRNewswire/ --
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Today, data from a post hoc analysis of the three-year part of the phase 3a SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence) Obesity and Prediabetes trial were presented at the first European Obesity Summit (EOS 2016). Adults with prediabetes and obesity or who were overweight with comorbidities were randomised to receive Saxenda(R) (n=1,505) or placebo (n=749) for 160 weeks, both as an adjunct to a reduced-calorie diet and increased physical activity. People treated with Saxenda(R) who lost 5% or more of their body weight at 16 weeks (classified as 'early responders') demonstrated greater weight loss and improvements in cardiometabolic risk factors at week 160 compared with those who lost less than 5% of their body weight at 16 weeks ('early non-responders').
At week 16, 68.0% of people treated with Saxenda(R) were early responders versus 22.3% of people treated with placebo. At week 160, Saxenda(R) early responders who completed the trial (n=580) achieved an average weight loss of 8.6% (9.1 kg), compared with 2.9% (3.1 kg) in early non-responders (n=210). In addition, Saxenda(R) early responders experienced improvements across a range of glycaemic measures including regression to normoglycaemia (69.8 vs 55.4%) and reduced development of type 2 diabetes (0.5 vs 3.2%) compared with early non-responders.
"These findings demonstrate the predictive nature of an early response to treatment, which is important information that clinicians can use to identify those who are most likely to experience long-term benefits with Saxenda," said Professor Sten Madsbad, Clinical Professor at the University of Copenhagen and SCALE(TM) clinical trial investigator. "It is also encouraging that we continue to see benefits in addition to weight loss experienced with Saxenda, including improvements in cardiometabolic risk factors and glycaemic status for people completing the trial."
For those completing 160 weeks of treatment, Saxenda(R) early responders also experienced greater improvements in systolic blood pressure (-3.7 vs -3.3 mmHg), and improvements in health-related quality of life measures (IWQoL-Lite score 13.4 vs 9.5) compared with early non-responders.
Saxenda(R) was generally well-tolerated, and observed side effects were in line with previous trials. Rates of adverse events were similar between early responders and early non-responders (97.1 vs 95.0%). The most common side effects reported by early responders and early non-responders were related to the gastrointestinal system (75.3 vs 71.6%). Gallbladder disorders were more frequent in early responders compared with early non-responders (6.3 vs 2.2%).
Obesity is a disease that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy., Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.,, It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In 2014, 13% of adults, or approximately 600 million adults, were living with obesity.
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, a hormone that is released in response to food intake. 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 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence) phase 3a clinical trial programme.
In the EU, 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