Sibutramine appears to safely promote weight loss in obese adolescents, according to a study conducted in Brazil. In fact, sibutramine treatment led to significant improvements in lipid profiles.

A previous study showed that sibutramine is effective for use in adolescents, but suggested that more data regarding safety and efficacy is required before the drug can be recommended for this population.

Dr. Amelio Godoy-Matos and colleagues at the Catholic University of Rio de Janeiro randomly assigned 60 obese 14- to 17-year-olds to treatment with sibutramine (10 milligrams daily) or placebo. Subjects also received dietary counseling and physical activity instructions.

After 6 months, those in the sibutramine arm had lost considerably more weight than those in the placebo arm (10.3 kg versus 2.4 kg). Fourteen subjects (46%) assigned to sibutramine, but none in the placebo group, lost at least 10% of their initial body weight.

There were no significant changes in blood pressure or heart rate in either group and no changes were observed on heart ultrasound or echocardiography.

Sibutramine was associated with significant decreases in triglycerides and very low density lipoprotein cholesterol at 24 weeks. The beneficial changes observed in the lipid profile “may have an important role” in preventing future cardiovascular disease, the authors suggest.

The only adverse event more commonly reported in the sibutramine group was constipation (12 subjects versus 4 subjects). Nevertheless, the authors suggest that larger clinical trials will be necessary to confirm their findings.

SOURCE: Journal of Clinical Endocrinology and Metabolism, March 2005.