The prevalence of overweight and obesity in children and adolescents is increasing rapidly.
In this population, behavioral therapy alone has had limited success in providing meaningful, sustained weight reduction.
Pharmacological treatment has not been extensively studied.
|Body mass index decreased by 0.6 with orlistat but increased by 0.3 with placebo|
|Journal of the Medical Association|
Dr Chanoine and colleagues determined the efficacy and safety of orlistat in weight management of adolescents.
The investigators conducted a multicenter, randomized, double-blind study at 32 centers in the United States and Canada over 54 weeks from 2000 to 2002.
The investigative team included 539 obese adolescents, aged 12 to 16 years with a body mass index 2 units above the 95th percentile.
The team randomized 357 patients to 120 mg of orlistat or 182 to placebo 3 times daily for 1 year, plus a mildly hypocaloric diet, exercise, and behavioral therapy.
The main outcome measures included by the team were changes in body mass index.
The secondary measures included changes in waist and hip circumference, weight loss, lipid measurements, and glucose and insulin responses to oral glucose challenge.
The investigators found a decrease in body mass index in both treatment groups up to week 12.
After week 12, body mass index in both treatment groups stabilized with orlistat but increased beyond baseline with placebo.
The investigative team found that at the end of the study, body mass index had decreased by 0.6 with orlistat but increased by 0.3 with placebo.
Compared with 16% of the placebo group, the team reported that 27% of participants taking orlistat had a 5% or higher decrease in body mass index.
The investigators also observed that 5% with placebo and 13% receiving orlistat had a 10% or higher decrease in body mass index.
At study end, the investigative team noted that weight had increased 0.5 kg with orlistat and 3 kg with placebo.
The team explained that this difference in weight increase was due to changes in fat mass, shown by using dual-energy x-ray absorptiometry.
The investigators also reported that waist circumference decreased in the orlistat group but increased in the placebo group.
In addition, mild to moderate gastrointestinal tract adverse events were identified in 9% to 50% of the orlistat group and in 1% to 13% of the placebo group.
Dr Chanione and team concluded, “In combination with diet, exercise, and behavioral modification, orlistat statistically significantly improved weight management in obese adolescents compared with placebo.”
“The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group.”