Is DL‐Fenfluramine a Potentially Helpful Drug Therapy in Overweight Adolescent Subjects?

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Abstract
We have studied the therapeutic effects of two different doses (30 mg and 60 mg, twice daily) of DL‐fen‐fluramine (DL‐F) in, respectively, prepuberal (11–13 years old) and adolescent subjects (14–17 years old). Sixty‐eight obese subjects were recruited for this study (22 boys, 36 girls, aged 10–17 years old) with body mass index ranging from 24.5 to 44.0 kg/m2, absolute weight ranging from 37.0 to 119.5 kg and % over IBW ranging from 122% to 260%. Results were compared to a placebo treated group of obese adolescent patients (n=17), 6 boys and 11 girls, aged 10–17 years old, BMI ranging from 26–44 kg/m2, absolute weight 53.1 to 96.5 kg, and with 129% to 253% over IBW. In the DL‐F‐treated subjects most patients (n=41) had a continuous weight loss during 12 months but 27 individuals were unable to lose any additional weight after the initial 6 months of the trial. Taken together 65% of all patients lost weight during DL‐F treatment (12 months) whereas only 17.4% of the placebo group lost a significant (>10% BMI) amount of excess weight. Also the placebo group had a higher withdrawal rate (57%) as compared with the DL‐F‐treated group (24%). There was a significant (p<0.05) decrease of the mean & SD of the BMI (at 6 and 12 months of therapy). No significant change of the BMI was observed for control group. Minor adverse side effects consisted of a brief period of drowsiness and dry mouth. Our findings indicated that the continuous administration of DL‐Fenfluramine might help obese adolescent subjects adhere to a diet and to maintain the weight loss achieved without major or harmful adverse effects.

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