Table of Contents 21-2

Addition of Orlistat to Conventional Treatment in Adolescents with Severe Obesity

Orlistat, a gastrointestinal lipase inhibitor, has been shown to have varying degrees of effectiveness in promoting and sustaining weight loss in obese adults. Its use in children and adolescents has not been studied extensively. Ozkan and associates report a long-term study in 42 obese adolescents who met the following criteria: severe exogenous obesity (defined as weight for height index index >140%), absence of endocrinopathy, genetic syndromes, or medications; and Tanner stage 2 or higher pubertal stage with ages between 10 years and 16 years. Subjects were randomized to conventional behavioral lifestyle treatment with or without Orlistat (120 mg tid). The lifestyle modification included a diet of 20% reduction in calories and a prescription of 30 minutes of moderate exercise daily. Subjects were examined every 2 months and compliance with diet and exercise was rated by the parents as poor, fair, or good. Twenty-two children (ages 12.9 ± 2.4 years) were randomized to receive the Orlistat treatment, and 20 (ages 12.5 ± 2.2 years) received the lifestyle intervention only. Seven of the 22 (31.8%) subjects dropped out of the Orlistat arm of the study due to gastrointestinal complaints, which included soiling and frequent defecation, and 5 of the 20 (25%) lifestyle-only group dropped out due to noncompliance with medical visits. Reported compliance by the parents with the lifestyle modification was similar in both groups: fair to poor. Average duration of treatment was 11.7 ± 3.7 months in the Orlistat group and 10.2 ± 3.7 months in the lifestyle-only group. At the end of the study, weight change was significantly different in the 2 groups: -6.27 ± 5.4 kg (Orlistat) vs +4.16 ± 6.45 kg (lifestyle only) ( p<0.001). Subjects in the Orlistat group lost –7.65% of their initial body weight, while the conventional treatment group gained 5.7% of initial body weight. The authors state that theirs is the first study of the safety and effectiveness of Orlistat treatment in children for a time period of more than 3 months. Studies in adults have shown that, in combination with a hypocaloric diet, Orlistat produces a greater weight loss than placebo for up to 2 years. Lifestyle intervention alone in the current study prevented further increases in BMI, but did not decrease the degree of obesity in that group. Long-term studies of Orlistat vs lifestyle intervention are required to confirm both its safety and effectiveness.

Ozkan B, Bereket A, Turan S, Keskin S. Eur J Pediatr. 2004;163:738–741.

Editor’s Comment: Obesity is becoming a greater and greater problem, not just in the United States, but worldwide. Effective measures for reducing the degree of obesity in children and adolescents are urgently needed. The current study suggests that using Orlistat, a lipase inhibitor that has been used in adults for a number of years, may be used successfully in some adolescents for up to 15 months. Longer studies are obviously needed. It is of particular interest that 25% of the conventionally treated group in this study dropped out for non-compliance with bi-monthly clinic visits. It is reasonable to assume that some of these may have dropped out because they failed to perceive any change in their weight using the lifestyle intervention. However, as pointed out by the authors, a recent Italian study of nutrition intervention in 1300 obese children had a drop-out rate of more than 90%. It would appear that lifestyle modification is perceived to be of little value by many obese children and their families. Part of that perception must rest with the way in which obesity is perceived and discussed by physicians and health care professionals. Until there is consensus on the seriousness of this epidemic and on the the need for immediate, and at times novel or drastic interventions, its frequency will continue to grow. Perhaps the addition of a pharmacological agent, such as Orlistat, can provide the impetus for patients to put more effort into successfully modifying the lifestyle contributors to this disease.

William L. Clarke, MD