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Division of Nutrology and Metabolism, Institute of Diabetes and Endocrinology of Rio de Janeiro (A.G.M., L.C., A.V., J.O., E.P.G., L.M., C.R.) and Obesity and Eating Disorders Group (GOTA), Institute of Psychiatry, Federal University of Rio de Janeiro / Institute of Diabetes and Endocrinology of Rio de Janeiro (R.O.M., W.C., J.C.A.)
* To whom correspondence should be addressed. E-mail: godoymatos{at}openlink.com.br.
Adolescent obesity is becoming a health problem in both developed and developing countries. Anti-obesity drug therapy is not currently indicated for the treatment of adolescent obesity, and remains investigational at this time. The aim of this study was to determine efficacy and safety of sibutramine in obese adolescents. A randomized, double-blind, placebo-controlled trial, enrolling 60 adolescents aged 14 to 17 yr for 6 months was conducted. In the first month, all patients received placebo and a hypocaloric diet plus exercise orientation. For the next six months, participants received either sibutramine or placebo. Patients assigned to sibutramine group lost an average of 10.3 ± 6.6 kg and patients in placebo group lost 2.4 ± 2.5 kg (P < 0,001). Mean BMI reduction was significantly greater in the sibutramine group (3.6 ± 2.5 kg/m2) than in placebo group (0.9 ± 0.9 kg/m2; P < 0.001). No participants withdrew because of adverse events and no differences in blood pressure or heart rate was noted between groups. There were no changes in echocardiographic parameters. In conclusion, sibutramine plus diet and exercise induced significantly more weight loss in obese adolescents.
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