For people with prediabetes who are overweight or obese, adding 3.0 mg of liraglutide for three years to a diet and exercise plan may lead to major health improvements, new industry-sponsored research suggests. The results will be presented Monday, April 4, at ENDO 2016, the annual meeting of the Endocrine Society, in Boston.
“Treatment with subcutaneous liraglutide 3.0 mg for three years, combined with a reduced-calorie diet and increased physical activity, can help people to not only lose weight, but also reduce the risk of Type 2 diabetes and improve cardiometabolic risk factors, which may ultimately reduce the risk of cardiovascular disease - the number one cause of death globally,” said lead study author Ken Fujioka, MD, director of nutrition and metabolic research, and director for weight management at Scripps Research Institute in La Jolla, California.
“Type 2 diabetes is a major cause of death in the US. Both obesity, a chronic disease with serious health consequences, and prediabetes, typically defined as blood glucose concentrations that are higher than normal but lower than diabetes thresholds, increase the risk of developing Type 2 diabetes,” Fujioka said. “For people with overweight or obesity and prediabetes, losing between 5 and 10 percent of their body weight can reduce their risk of Type 2 diabetes and other obesity-related health consequences.”
Over a three - year period, the researchers studied 2,254 overweight and obese adults whose average age was around 48 years and who also had either high cholesterol or high blood pressure, or both. The authors randomly assigned 1,505 participants to treatment with liraglutide 3.0 mg and 749 participants to treatment with placebo. All patients were put on a 500-calorie-per-day diet and a 150-minute-per-week physical activity program, and they were given counseling.
After three years, those taking liraglutide lost weight and lowered their risk of Type 2 diabetes. Overall, 66 percent of participants taking liraglutide no longer had prediabetes and returned to normoglycemia, compared with 36 percent of those on placebo.
The liraglutide group’s blood glucose levels dropped to normal, their waist circumference was smaller and their cardiometabolic risk factors, including systolic blood pressure and some fasting lipids and cardiovascular biomarkers, decreased.
Liraglutide (marketed as Victoza) Information
FDA approved Victoza (liraglutide) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Additionally, Victoza is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Side effects and serious event rates were similar in both groups. Major adverse cardiovascular events were generally low, and no new safety issues were found. Of the four people who died, two were on liraglutide and two were on placebo.
Novo Nordisk A/S, Denmark, funded the study.
The US Food and Drug Administration (FDA) has approved the diabetes drug liraglutide (Saxenda, Novo Nordisk) for the treatment of obesity.
The specific indication is as an adjunct to lifestyle for chronic weight management in individuals with a body mass index of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, diabetes, or dyslipidemia.
Available in the United States since 2010 for the treatment of type 2 diabetes as Victoza (Novo Nordisk), liraglutide is a glucagonlike peptide-1 (GLP-1) receptor agonist. The dose for obesity is 3.0 mg, in contrast to 1.2 mg or 1.8 mg for diabetes. Liraglutide should not be used with any other drug in the GLP-1 class, including Victoza, according to the FDA.
Patients should be evaluated after 16 weeks and the drug discontinued if the patient has not lost at least 4% of baseline body weight.
Liraglutide now becomes the fifth available obesity drug in the United States, after orlistat (Xenical, Genentech; and Alli, GlaxoSmithKline), lorcaserin (Belviq, Eisai), phentermine-topiramate (Qsymia, Vivus), and bupropion/naltrexone (Contrave, Takeda Pharmaceuticals).
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