Apr. 9, 2003 (Philadelphia., PA) -- A study by researchers at the Weight and Eating Disorders Program of the University of Pennsylvania School of Medicine reports the results of the first controlled trial in overweight teenagers of an FDA approved weight loss medication, sibutramine (brand name MERIDIA). Sibutramine is approved by the FDA for obese patients aged 16 years or older. Adolescents treated for 6 months by behavior modification combined with sibutramine lost more than twice as much weight as those who received behavior modification plus placebo (sugar pill). Those receiving sibutramine also reported greater reductions in hunger.
The study, to be published in the April 9th issue of the Journal of the American Medical Association, was conducted by Robert Berkowitz, MD, Associate Professor of Psychiatry and Thomas Wadden, PhD, Professor of Psychology in Psychiatry. The study investigated 82 adolescents who were between 13 and 17 years of age and had an average body weight of 228 pounds. Participants treated by sibutramine lost an average of 17.2 pounds compared with 7 pounds in the placebo group.
Sibutramine (Meridia) works by increasing the levels of two neurotransmitters in the brain – serotonin and norepinephrine – which affect appetite. In this study, hunger levels decreased twice as much in the medication group compared with the placebo. All adolescents participated in a behavior modification program in which they were instructed to consume a nutritionally balanced 1200 – 1500 calorie a day diet and to increase their physical activity to at least 30 minutes per day on 4 or more days of the week.
“Adolescent obesity is becoming a national public health problem. The addition of sibutramine to a comprehensive behavioral program induced significantly more weight loss than did the behavioral program and placebo, “ Berkowitz stated. "Further, during the second six months of the study, the teens who continued to receive both behavior modification and medication kept their weight off.”
“Teens who both closely followed the behavioral program and received medication lost the most weight, an average of 23 lbs.,” Wadden reported. Weight loss also was associated with improvements in insulin levels. A significant number of adolescents treated by sibutramine experienced increased blood pressure or pulse rate which required reductions in the dose of medication. The authors recommend that sibutramine be carefully monitored in all patients to prevent increases in blood pressure and pulse rate.
Results of this placebo-controlled study suggest that the weight loss medication may be of benefit to obese adolescents when combined with a comprehensive behavioral program. "Larger and longer studies are needed to assess the benefits and costs of pharmacological treatment in obese adolescents. Until more extensive safety and efficacy data are available, we believe that weight-loss medications should be used only on an experimental basis with adolescents,” Berkowitz stated.
This study was funded through grants from the National Institutes of Health, the General Clinical Research Center of The Children’s Hospital of Philadelphia, and from Abbott Laboratories. Abbott Laboratories manufactured and provided both sibutramine and placebo for the study.
Others who participated in the study are Joanna Cronquist, Research Coordinator, of Penn, and Andrew Tershacovec, MD, formerly of Penn and Children's Hospital of Philadelphia.
Berkowitz and Wadden have served as consultants to Abbott Laboratories, and Wadden was a member of Abbott's former speakers bureau and has received honoraria from Abbott. In addition, Berkowitz, Wadden and Tershakovec have received research funding from Abbott.
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