Washington — Exenatide helps increase weight loss in obese nondiabetic patients who also are following a diet and exercise program, recent study results suggest.
Dr. Michael Trautmann, a researcher at Eli Lilly & Co., and his colleagues conducted a double-blind, placebo-controlled study of 152 patients with a mean body mass index of 39.6 kg/m
As is typical with obesity studies, 35% of patients originally enrolled did not complete the study, Dr. Trautmann said.
Patients were randomized to receive placebo or 10 mcg exenatide twice daily. Lifestyle modification—comprising a balanced, calorie-restricted diet; moderate increase in physical activity, with a target of 150 minutes per week; and counseling sessions at 4-week intervals—was prescribed for all participants, Dr. Trautmann said at the annual meeting of the Endocrine Society.
The study's primary end point was change in body weight. Secondary end points included changes in glucose tolerance, physical activity, and dietary behavior. After 24 weeks, a significantly higher percentage of exenatide-treated patients had lost at least 5% of their body weight, compared with patients on placebo (31% vs. 17%), Dr. Trautmann said. All of the patients who had lost 10% or more of their body weight were in the exenatide group.
The average weight loss in the placebo group was 1.6 kg. In the exenatide group, the average weight loss was 5.1 kg, “a highly significant difference,” he said.
In subgroup analysis, “due to the small sample size, one cannot conclude too much from these results, but the trend indicates that in patients with mild obesity—with a BMI of less than 35 kg/m
Among patients with impaired glucose tolerance at baseline, three-quarters who were on exenatide normalized their glucose levels, compared with slightly more than half of the patients on placebo, he said. “Clearly, weight loss is known to improve glucose tolerance.”
Side effects with exenatide included mild to moderate nausea, which was experienced by 25% of those in the exenatide group, compared with 4% of those on placebo. The nausea rate in the exenatide group was lower than has been seen in type 2 diabetes patients who are taking exenatide, he said.
No hypoglycemia occurred among patients on exenatide, “again confirming the strict glucose dependence of the insulin secretion induction by GLP-1 receptor agonists,” Dr. Trautmann said.
The study was sponsored by Eli Lilly and Amylin Pharmaceuticals.
All of the patients who had lost at least 10% of their body weight were in the exenatide treatment group.
Source DR. TRAUTMANN