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Researchers Express Concern Despite Benefits Of Weight-Loss Medication In Obese Adolescents

Weight-loss medication may benefit obese adolescents, but researchers in the United States suggest that its use be limited to experimental studies until more extensive safety and efficacy data are available.

Investigators from the University of Pennsylvania and the Children's Hospital of Philadelphia, report that adding sibutramine to comprehensive behavioural therapy (BT) induced significantly more weight loss in a study of 82 obese teenagers than did BT and placebo. "Results of this controlled trial of sibutramine in adolescents suggest there may be benefits of combining behavioural and pharmacological therapies," they say.

But, the researchers also express concerns about the management of increases in blood pressure, pulse rate and other symptoms observed in the treated adolescents.

"Sibutramine must be carefully monitored in adolescents, as in adults, to control increases in blood pressure and pulse rate."

"Moreover, larger and longer studies are needed to assess the benefits and costs of pharmacological treatment in obese adolescents," they state.

Participants in the March 1999 to August 2002 trial were aged from 13 to 17 years and had a body mass index (BMI) of 32 to 44. They were randomised to either BT and sibutramine or BT and placebo at a university-based clinic for six months. This was followed by another 6 months of open-label care in which all participants received the drug.

At the end of 6 months, patients receiving BT and sibutramine had an 8.5% reduction in BMI, compared with a 4% BMI reduction in placebo patients. Adolescents receiving sibutramine also had significant reductions in hunger.

Between 7 and 12 months, the adolescents initially taking sibutramine gained 0.8 kilograms, while those who initially received placebo lost an additional 1.3 kg.

The researchers point out that medication dose was reduced in 23 patients and discontinued in 10 others in order to manage blood pressure, pulse rate and other symptoms.
JAMA 2003;289:14:1805-1812.

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