The Pharmaceutical Journal
Vol 270 No 7244 p504
12 April 2003

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Care needed over use of obesity drug in teenagers

Despite showing that sibutramine (Reductil) can help teenagers lose weight, the authors of a new study say that drugs used for weight loss should only be used for this age group as part of a clinical trial.

Dr Robert Berkowitz, of the University of Pennsylvania school of medicine, Philadelphia, and colleagues conducted a double-blind trial involving 82 obese adolescents aged 13 to 17 years. All of the teenagers in the study received the same family-based behavioural weight loss programme but half were randomised to receive 5mg of sibutramine daily while half received placebo. The dose of sibutramine was increased to 10mg daily after three weeks and to 15mg daily after seven weeks.

The researchers found that after six months' treatment, teenagers in the sibutramine group had lost 7.8kg (±6.3kg) equal to an 8.5 per cent reduction in body mass index (BMI). In contrast, adolescents treated with placebo lost 3.2kg (±6.1kg) equal to a 4.0 per cent reduction in BMI. In addition, more than twice as many sibutramine-treated teenagers than placebo-treated teenagers had their initial BMI reduced by 10 per cent and 15 per cent (P=0.02 for both).

The researchers comment that adolescents who adhered closely to the behavioural programme and who were treated with sibutramine achieved the greatest decrease in BMI during the first six months. "The behavioural and pharmacological treatments appeared to have additive effects that maximised weight loss," they say.

Despite their findings, the researchers are cautious about recommending the use of weight loss drugs for the treatment of obesity in children and adolescents. They point out that patients taking sibutramine must be carefully monitored to control increases in blood pressure and pulse rate. "Until more extensive safety and efficacy data are available ... weight-loss medications should be used only on an experimental basis for adolescents," they say (JAMA 2003;289:1805).

Authors of an accompanying editorial (ibid, p1851) comment that improvements seen in co-morbid conditions associated with obesity, such as insulin resistance and dyslipidemia, were no different in adolescents receiving sibutramine or placebo. In addition, they point out that it is unknown whether sibutramine will continue to be effective for reducing body weight in the long term.

Reductil is not licensed for use in children and adolescents under 18 years or in adults over 65 years.