Cardiovascular Effects of Sibutramine in the Treatment of Obese Adolescents: Results of a Randomized, Double-Blind, Placebo-Controlled Study

Abstract

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 ≥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.