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New Data Show Saxenda (Liraglutide) Provides Benefits Beyond Weight Loss
New data from a post hoc analysis of the phase IIIa SCALE (Satiety and Clinical Adiposity –– Liraglutide Evidence in Nondiabetic and Diabetic People) clinical development program were presented at the European Congress on Obesity (ECO), demonstrating both the weight-loss–dependent and –independent effects of Saxenda (liraglutide 3 mg, Novo Nordisk).
A mediation model was applied to determine the weight-loss–dependent effects of treatment, with a score of 100% indicating full dependence. Endpoints primarily driven by weight loss (88% to 100%) included waist circumference, diastolic blood pressure, triglycerides, high-density lipoprotein (HDL) cholesterol levels, the apnea–hypopnea index (sleep apnea severity), and the effect of weight on the quality-of-life (IWQoL) total score and on the physical-function score.
Endpoints that improved as a result of treatment with liraglutide 3 mg, but were independent of weight loss (18% to 32%), included glycemic endpoints (hemoglobin A1c and fasting plasma glucose), as well as a reduction in the use of oral antidiabetic treatments. However, a reduction in body weight still contributed to these treatment effects.
Across the SCALE clinical development program, liraglutide 3 mg was generally well tolerated. The most common adverse effects were related to the gastrointestinal system.
Obesity is a disease that requires long-term management. It is associated with many serious health consequences and with a decreased life expectancy. Obesity-related comorbidities include type-2 diabetes, heart disease, obstructive sleep apnea, and certain types of cancer. It is a complex and multifactorial 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 health care systems.
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, liraglutide 3 mg regulates a person’s 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, liraglutide 3 mg stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner. These effects can lead to reductions in fasting and postprandial blood glucose levels.
Saxenda (liraglutide 3 mg) was approved by the FDA in December 2014 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, such as hypertension, type-2 diabetes mellitus, or dyslipidemia.
The labeling for Saxenda includes a boxed warning regarding the risk for thyroid C-cell tumors.
Sources: Novo Nordisk; May 8, 2015; and Saxenda Prescribing Information; January 2015.