Effect of Orlistat on Weight and Body Composition in Obese Adolescents

Abstract

HE PREVALENCE OF OVERweight in adolescents is increasing worldwide. In the United States, the proportion of adolescents with a body mass index (BMI) at or above the 95th percentile for age, a widely accepted definition of obesity in adolescents, 1,2 has increased 15.5% to 23.4% in certain ethnic minorities. 3 A similar picture is seen in European countries: the prevalence of overweight in adolescents has increased 8% to 21% in northern European countries and 17% to 23% in southern European countries. 4 Excess weight in adolescents is associated with an increased risk of disorders such as hyperlipidemia and type 2 diabetes 5 and can result in decreased emotional and physical quality of life. 6,7 In addition, childhood obesity results in increased risk of morbidity and mortality in adulthood. 8,9 Long-term follow-up studies of children and adolescents indicate that overweight children have a 15-fold greater risk of becoming overweight adults compared with those children and adolescents who were not overweight. 8 Effective weight management in children and adolescents may therefore have important immediate and future societal health benefits. Treatment of obesity in the pediatric age group, and in particular during adolescence, 10 is notoriously difficult. While behavioral therapy has had some success in treating obesity in young children (aged 6-12 years), most stud-For editorial comment see p 2932.

Clinical research in adolescents: challenges and opportunities using obesity as a model

“…For example, since the early 1980s, there have been only 13 published randomised controlled trials (RCTs) of obesity management among adolescents. [28][29][30][31][32][33][34][35][36][37][38][39][40] All but four of these were performed in North America, usually in a tertiary care setting, and all involved intense behavioural management support. Follow-up periods for the majority of studies were 6 months or less.…”

“…Three studies involved pharmacotherapy. [37][38][39] In adults, there is an excellent evidence base for the use of bariatric surgery as the most effective treatment for obesity and its comorbidities. 41 To date, there have been no published randomized controlled trials of the use of bariatric surgery in adolescents.…”

Type 2 Diabetes in Children: A Growing Epidemic

“…20 Attempts at managing weight via diet, exercise, behavioral modifi cation, and pharmacological means may translate into control of plasma glucose. 21 Pharmacological treatment of obesity may become more prevalent as clinicians attempt to treat overweight and obese children who have diabetes as a means to prevent glucose intolerance. Typically a lowfat, low-calorie diet should be used as fi rst-line therapy.…”

“…Orlistat (120 mg TID) or placebo was given for 54 weeks to 357 and 182 patients, respectively. 21 Both groups were placed on a mildly hypocaloric diet (30% calories as fat), given exercise counseling, and provided specifi c behavioral modifi cations. No assessment was made to determine if the participants followed these guidelines.…”

New drug policy in childhood obesity

“…The orlistat treatment had a side effect profile similar to that observed in adults, but its true benefit vs conventional therapy remained to be determined in placebo-controlled trials. The results of a randomised, 54-week double-blind, placebo-controlled study investigating the safety and efficacy of orlistat in obese adolescents were presented at the 13th European Congress on Obesity, Prague in 2004 23 and published recently in JAMA. 24 The study included 539 adolescents (357 on 120 mg orlistat, 182 on placebo), but only 349 completed (232 active, 117 placebo) the study.…”