Sibutramine ( Meridia/Reductil ) added to a behavior therapy program reduced BMI ( body mass index ) and body weight more than placebo and improved the profile of several metabolic risk factors in obese adolescents.

The study enrolled 498 severely obese adolescents, aged 12 to 16, in 33 outpatient clinics throughout the United States from 2000 to 2002.
The patients were randomized into two double-blinded groups, one receiving Sibutramine ( 10 mg ) and one receiving a placebo, while both groups received behavior therapy.
Blinded study medication dose was uptitrated to 15 mg or placebo at month 6 if initial BMI was not reduced by 10%.

Each treatment center had its own behavior therapy program, with flexible modification approaches that included self-monitoring of eating habits and physical activity, stress management, stimulus control, problem solving and social support. Counselors encouraged patients to increase their physical activity and reduce their sedentary behaviors, and provided nutritional counseling.

At the end of the study, the 281 adolescents in the treatment group lost an average of 14 pounds, while the 79 patients in the control group gained an average of 4 pounds.
BMI decreased by 9.4 percent in the treatment group compared to 1.2 percent in the control group.
Patients in both groups gained height and matured sexually at the same rate.

The standard definition of overweight in adolescents usually refers to those with a BMI greater than the 95th percentile for age and sex.
The study focused on heavier patients, those with a BMI two units more than the 95th percentile, placing them at roughly the 97th percentile. Their mean weight was approximately 215 pounds.

At the end of the study, 33 percent of the patients who received Sibutramine, compared to 7.6 percent in the control group, no longer had a BMI that was 2 units above the 95th percentile. Furthermore, 16.7 percent of the treated patients had their BMI drop below the 95th percentile ( vs. 3.8 percent in the control group ).

The Sibutramine group had greater improvements in triglyceride levels, high-density lipoprotein cholesterol levels, insulin levels, and insulin sensitivity.

The rate of tachycardia was greater with Sibutramine vs. placebo ( 12.5% vs. 6.2%; difference, 6.3 percentage points ) but did not lead to increased withdrawal ( 2.4% vs. 1.5%; difference, 0.9 percentage point ).

" At the end of a year of treatment, one-third of the adolescents who received medication were no longer severely overweight, and one out of six who were treated dropped below the standard definition of being overweight," said Robert I. Berkowitz, at The Children's Hospital of Philadelphia. " We know that moderate weight loss in adults helps prevent or delay progression to type 2 diabetes. This may also be true in adolescents, although this study cannot address that question."

The 1-year study duration precluded assessment of long-term weight maintenance and putative health benefits and harms, and 24% and 38% of the Sibutramine and placebo groups, respectively, did not complete follow-up.

Sibutramine has not been approved by the FDA ( Food and Drug Administration ) for use in adolescents under age 16.

Source: Annals of Internal Medicine, 2006


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