Reprinted from Eating Disorders Review
May/June 2005 Volume 16, Number 3
©2005 Gürze Books
Q: Are any anti-obesity drugs currently being prescribed for teens? (A.Z., Key West, FL)
A: Antiobesity drug therapy is widely accepted for adults, but few agentsare approved for this use. Sibutramine is among the few agents currently approved for treating obesity among adults. Recently a team of Brazilian researchers designed a randomized controlled trial of sibutramine among obese adolescents (J Clin Endocrinol Metabol 2005; 90:1460). The researchers wanted to determine if this drug, plus diet and exercise, was safe, tolerable, and effective for obese adolescents when given in a clinical setting. The authors used a single-blind, four-week, placebo run-in period was followed by a 6-month, randomized, double-blind, placebo-controlled period. Sixty boys and girls aged 14 to 17 years who had body mass indexes (BMIs) ranging from 30 to 45 and who were otherwise healthy joined the study. During the first month, all patients received placebo and a low-calorie diet plus moderate aerobic exercise. Then, for the next 6 months, participants received either sibutramine or placebo. During the study, blood tests and echocardiograms were performed.
Of the 60 obese adolescents who completed the run-in period and were randomized to sibutramine or placebo, 10 withdrew from the study (8 in the placebo group and 2 in the sibutramine group). Those in the placebo group withdrew due to nonadherence to the protocol or to loss of follow-up, withdrawal of consent, and pregnancy. No one in either group withdrew due to adverse effects.
Participants in the sibutramine group lost an average of 10.3 kg, and those in the placebo group lost an average of 2.4 kg. Mean BMI reduction was also significantly greater in the sibutramine group than in the placebo group (3.6 vs. 0.9 kg/m2). More than five times as many adolescents assigned to the sibutramine group (14) than those in the placebo group lost at least 10% of their initial weight. Approximately 25% of adolescents assigned to the sibutramine group (7 teens) reduced their initial weight by at least 15% compared with teens in the placebo group.
Constipation was the only adverse effect that was significantly increased in those receiving sibutramine treatment. Because damaging heart valves and
development of other cardiac abnormalities have been concerns with anti-obesity drugs, the researchers performed echocardiographic studies to evaluate the drug’s safety. No changes were noted; regurgitation was found in a few patients at baseline and after treatment was found to be a pre-existing condition. No cardiac valve changes were observed.