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Investigators examined the efficacy and safety of orlistat, a gastrointestinal tract lipase inhibitor that decreases intestinal fat absorption, for treating obese adolescents in combination with diet, exercise, and behavioral therapy. The 539 obese adolescents, whose body mass index (BMI) was at least two units above the 95th percentile, received 120 mg of orlistat or placebo three times daily. Both groups were maintained on a nutritionally balanced diet with a caloric intake ranging from 1,400 to 1,800 kcal/day for boys and 1,200 to 1,600 kcal/day for girls.
Behavioral modification programs in the study focused on recording food intake and activity; limiting the presence of high-calorie and high-fat foods in the home; restricting eating to dining areas and to meal times; eating slowly; recognizing cues to overeating; and substituting new behaviors for overeating. Investigators also provided guidelines to subjects to encourage them to take regular physical activity and reduce sedentary activities.
During the first 12 weeks of the one-year, multicenter study, BMI decreased in both groups. Later, BMI tended to stabilize in the orlistat group but increased beyond the baseline level in the placebo group. By the end of the study, mean BMI had decreased by 0.55 from baseline in participants taking orlistat and had increased by 0.31 from baseline in those taking placebo. Compared with 15.7% of the placebo group, 26.5% of the orlistat group had a 5% or greater decrease in BMI; 4.5% of the placebo group had at least a 10% decrease in BMI, compared with 13.3% of the orlistat group.
Both groups had similar changes in lipid and glucose levels. Waist circumference and diastolic blood pressure decreased in the orlistat group but increased in the placebo group. Both groups experienced some generally mild or moderate gastrointestinal tract adverse events, although they were more common in the orlistat group (Chanoine JP et al: JAMA 2005;293:2873).
This drug is no silver bullet but, in combination with diet, exercise, and behavioral therapy, may be an effective weapon for physicians treating child and adolescent obesity. Pediatricians are looking for such solutions: In a recent survey of 356 pediatricians, Peru and colleagues (Ambul Pediatr 2005;5:150) found that only 12% of respondents had confidence in their ability to prevent and treat obesity.