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Title: Sibutramine Helps Adolescents Lose Weight: Presented at ENDO

"Sibutramine Helps Adolescents Lose Weight: Presented at ENDO"

By Mike Fillon NEW ORLEANS, LA -- June 21, 2004 -- Obese teens who took the weight-loss drug sibutramine for 6 months experienced substantial weight loss without harmful side effects, according to study findings. Sibutramine is sold as Meridia in the United States. This new study is one of the first to show the effectiveness of drug therapy on obese adolescents, according to a report presented here on June 17[^th by Amelio Fernando de Godoy Matos, MD, in a clinical oral session at the 86th Annual Meeting of The Endocrine Society (ENDO). Dr. Matos is a professor in endocrinology of the Pontifical Catholic University and State Institute of Diabetes and Endocrinology in Rio de Janeiro, Brazil.

Adolescent obesity is a health problem in both developed and developing countries. As a result, adolescents are becoming ill as a consequence of obesity and obesity-related diseases, such as diabetes and high blood pressure.

According to Dr. Matos, until now, there has been a lack of research on drug therapy for obese adolescents, despite the lack of results in conventional treatment of obesity in this age group.

The researchers conducted a double-blind study of 60 obese boys and girls, 14 to 18 years old with an average weight of 220 pounds, and randomized them to either sibutramine or placebo for 6 months. Both groups also participated in a controlled diet, moderate exercise and counseling.

After 6 months, the patients taking sibutramine lost an average of 28 pounds while those taking the placebo lost only about 11 pounds. Also, more than 6 times as many adolescents taking sibutramine reduced their initial body weight by at least 10%, compared with the placebo group. In addition, 50% of the sibutramine group reduced their body weight by at least 15%, compared with none in the placebo group.

"Patients in the sibutramine group, not only lost more weight, but they also experienced significant improvements in good cholesterol, HDL, and insulin levels," says Dr. Matos. The researchers found there were no differences in blood pressure, heart rate and echocardiography readings between the groups.

No participants withdrew from the study due to adverse events, and the only event that occurred more frequently among the patients who took sibutramine over those who took placebo was constipation (P =.039).

"Based on our findings, sibutramine appears to be a safe and effective treatment for obesity in adolescents," concludes Dr. Matos. "We believe larger and longer studies are needed to confirm these findings."

Financial Support for the study was provided by Abbott Laboratories.

[Presentation title: Treatment of Obese Adolescents with Siburtramine: A Randomized, Double-Blind, Placebo-Controlled Trial. Abstract # OR19-1]

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