Combination Behavior / Drug Therapy Tested To Treat Teen Obesity

The number of obese teens in the U.S. is rising fast. In the 1980s, 5 percent of teens were obese. Twenty years later, that level has grown to more than 15 percent. With this increase in obesity has come a dramatic rise in type 2 diabetes and related health problems. A combination of behavioral and drug treatment of obesity in adolescents is under investigation.

Pharmacotherapy is a widely used treatment option for obese adults. However, no weight-loss drugs are currently approved by the Food and Drug Administration (FDA) for patients under the age of 16.

Sibutramine, a medication that suppresses appetite, is now being tested in teens. In the first randomized, placebo-controlled trial of the drug in youth who are obese, researchers found that the addition of sibutramine to family-based behavioral therapy significantly increased weight loss.

Eighty-two obese boys and girls ages 13 to 17 were coached in eating a 1,200 to 1,500 calorie diet, building up to 120 minutes of walking per week, and keeping a daily eating and physical activity log. Parents attended separate sessions. The teens were randomized to receive either sibutramine or placebo for 6 months. Neither participants nor study personnel knew who received which treatment. In the second 6 months of the study, behavioral therapy continued and all participants knowingly received sibutramine.

After the first 6-month period, participants in the sibutramine group lost about 17 pounds (7.8 kilograms) or 8.5 percent of their initial body mass index (BMI). Those receiving placebo lost about 7 pounds (3.2 kilograms), or 4.0 percent of their BMI.

"... no weight-loss drugs are currently approved by the Food and Drug Administration (FDA) for patients under the age of 16."

In adults using weight-control medications, maximum weight loss usually occurs within 6 months of starting treatment. Weight then tends to level off or increase during the rest of treatment.
The results in teens were similar. In the second 6 months, sibutramine group members maintained their weight loss. Those receiving placebo in the first 6 months and sibutramine in the second 6 months lost a total of about 10 pounds (4.5 kilograms) or 6.4 percent of their BMI.

Researchers guess that the smaller weight loss of the placebo group after switching to sibutramine may be due to the fewer number of behavioral weight-loss sessions held during the second 6 months—half as many as during the first 6 months. “The behavioral and pharmacological treatments appeared to have additive effects that maximized weight loss,” state the study authors.
The primary known side effects of sibutramine in adults are elevations in blood pressure and pulse. Teen study participants taking sibutramine also experienced these effects. During the full 12-month study, medication dose was reduced in 23 participants and discontinued in 10.

Results of other measures showed that after 12 months, participants’ levels of high-density lipoprotein (HDL) cholesterol increased significantly, and insulin levels decreased significantly. These results show the positive effect that weight loss can have on factors related to the development of type 2 diabetes.

Current studies show comprehensive behavioral treatment to be the most effective approach for treating adolescent obesity. Study authors agree that weight-loss medications should only be used on an experimental basis with adolescents and that more research is needed. Results of this investigation suggest that the addition of sibutramine to a comprehensive behavioral program may be a possible treatment option in the future.

In an editorial accompanying the research report, Drs. Jack and Susan Yanovski urge caution in treating obese youngsters with intense interventions

found effective in adults, such as drug treatment and surgery. While supporting additional research into effective treatment methods, they submit that “the ultimate goal must be prevention of the development of overweight in children and adolescents.”

The full report of this study, which was partially funded by NIDDK, appears in the April 9, 2003 Journal of the American Medical Association.. s