. (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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