Berkowitz, R. I., Fujoka, K., Daniels, S. R., Hoppin, A. G., Owen, S., Perry, A. C., & Sothern, M. S., for the Sibutramine Adolescent Study Group. (2006). Annals of Internal Medicine, 145(2), 81-90.
Adolescent obesity is now recognized as a major public health problem in the United States. Substantial data indicate obesity clusters with cardiovascular risk factors in adolescents and is associated with numerous comorbidities, including Type 2 diabetes.
Prevention of overweight is the optimal approach; however, effective treatment options for obese children [body mass index (BMI) equal to or greater than the 95th percentile for age and sex (determined by the 2000 Centers for Disease Control and Prevention growth Charts)] are needed. Toward this goal, this 12-month, randomized, double-blind trial was designed to determine if a pharmacologic agent (sibutramine) reduced weight more than the placebo in adolescents with obesity who were also receiving a behavior therapy program. Participants (n = 498) were 12-16 years old with a BMI of at least 2 units more than the U.S.-weighted mean of the 95th percentile based on age and sex, to the upper limit of 44 kg/m2. The behavioral protocol included site-specific therapy with emphasis on lifestyle modifications tailored to the participants' needs. Counseling at each visit was designed to promote physical activity, reduce sedentary behavior, and develop healthy eating patterns, with dietary consumption based on a 500-kcal/day deficit. Participants were randomly assigned to receive 10 mg of sibutraime or placebo daily. At 6 months, doses for participants who had not lost more than 10% of their initial BMI were uptitrated (blinded) to 15 mg of drug or placebo. Results indicated that 77% of the participants in the sibutramine group and 62% in the placebo group completed the study. The sibutramine group demonstrated significantly greater improvements in serum levels of triglycerides, high-density lipoprotein cholesterol, insulin, and insulin sensitivity (p < .001 for all), and a higher prevalence of tachycardia than the placebo group.
Collectively, these results indicate short-term safety and efficacy of pharmacotherapy (sibutramine) combined with behavior therapy as a potential option for the treatment of obesity in highly select adolescents who are morbidly obese and have metabolic comorbidities. As the authors also indicate, prevention (through healthy lifestyle behaviors) is the optimal approach. Nurses are particularly well prepared and well positioned across healthcare and community settings to promote the development and maintenance of healthy lifestyle behaviors and encourage children and adolescents to modify unhealthy behavior/lifestyle patterns.
Laura L. Hayman