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Cardiovascular effects of sibutramine in the treatment of obese adolescents: results of a randomized, double-blind, placebo-controlled study.

Daniels SR, Long B, Crow S, Styne D, Sothern M, Vargas-Rodriguez I, Harris L, Walch J, Jasinsky O, Cwik K, Hewkin A, Blakesley V,

Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA. daniels.stephen@tchden.org

BACKGROUND: Adolescent obesity is a major public health problem. Treatment options in addition to behavioral therapy could include pharmacotherapy with sibutramine. OBJECTIVES: Concerns regarding increases in blood pressure and heart rate after sibutramine treatment in some adult patients precipitated the present analysis, which evaluated the cardiovascular safety of sibutramine plus a behavioral therapy program in obese adolescents. PATIENTS AND METHODS: With this 12-month, randomized, double-blind, placebo-controlled trial in 33 US clinics we studied 498 adolescents aged 12 to 16 years with multiethnic backgrounds and BMIs of 28.1 to 46.3 kg/m2. RESULTS: The subjects were randomly assigned to behavioral therapy plus 10 mg of sibutramine or behavioral therapy plus placebo daily. At the end point, there was a mean treatment group difference in BMI of 2.6 kg/m2 in favor of sibutramine. Small mean decreases in blood pressure and pulse rate were seen in both sibutramine and placebo groups at the end point (systolic blood pressure: -2.1 vs -2.1 mmHg; diastolic blood pressure: -0.1 vs -1.1 mmHg; pulse rate: -0.2 vs -1.8 bpm). In both treatment groups, these reductions in vital signs were greater at the end point when BMI reduction was > or = 5% compared with < 5%. CONCLUSIONS: Sibutramine may have some direct cardiovascular effects on obese adolescents. These cardiovascular effects may be balanced by a reduction in BMI, which, in adolescents, seems to be greater than that observed in adults.

Published 3 July 2007 in Pediatrics, 120(1): e147-57.
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