Dexfenfluramine in the treatment of juvenile obesity

BACKGROUND: The aim of this study was to investigate the potential of dexfenfluramine (dF) for reducing cardiovascular risk factors and improving compliance towards diet in a group of young patients hospitalized for essential obesity of high degree (BMI > or = 35). METHODS: 103 adolescents (mean age 15.4 +/- 0.2) participated in a nine-week randomized double-blind study of dF (15 mg bid) versus placebo. All patients received a VLCD (2,512 kJ/day = 600 kcal/day) for two months. In basal conditions, and after 30 and 60 days of treatment, anthropometric variables (height, weight, BMI, and W/H) and cardiovascular risk factors (blood glucose concentration, total cholesterol, HDL-cholesterol, triglycerides, systolic and diastolic blood pressure) were monitored. Modifications in hunger and satiety were also assessed. RESULTS: During the treatment period, both the dF group and the placebo group presented a similar pattern of weight loss (BMI = dF: 36.7 +/- 0.5 vs 32.5 +/- 0.4 vs 30.1 +/- 0.4; placebo: 37.0 +/- 0.6 vs 33.1 +/- 0.5 vs 30.8 +/- 0.5). No important side-effects were recorded in either group. Blood pressure and metabolic markers decreased significantly in both groups. Earlier reductions in total cholesterol and diastolic blood pressure in dF-treated subjects were the only significant differences observed as compared to the patients receiving placebo (day 30 = total cholesterol: 120 +/- 2 (dF) vs 132 +/- 3 (placebo) mg/dI; p < 0.005; diastolic blood pressure: 73 +/- 1 (dF) vs 77 +/- 1 (placebo) mmHg; p < 0.01). However, after 60 days, these values were similar in the two groups. As far as non-parametric data are concerned, dF determined a reduction in hunger and an increase in satiety in a significantly higher number of subjects than did the placebo, not only after 30 days of treatment (92.8% vs 55.3% and 92.8% vs 45.5%, respectively; p < 0.0001), but also after two months of treatment (97.8% vs 67.4% and 97.8% vs 45.8%, respectively; p < 0.0001). CONCLUSIONS: These findings demonstrate that dF represents a useful support in the treatment of juvenile obesity and might ensure a better individual compliance towards restrictive diets, particularly in the initial "critical" stages, in the absence of important side-effects.