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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
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Current GGH - Vol. 24 No. 1
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