Dexfenfluramine as an adjunct to a reduced-fat, ad libitum diet: effects on body composition, nutrient intake and cardiovascular risk factors.

In a double-blind, randomized, placebo-controlled study 84 obese subjects were stabilized on the dietary program during a 12 w run-in period and then were randomized to receive dexfenfluramine (dF) in a dose 15 mg or placebo for an additional 12 w. One follow-up was conducted 12 w after cessation of treatment. Body composition (by DEXA), fat distribution (by circumferences and DEXA), nutrient intake (by 7 d food diaries), blood lipids, blood glucose and blood pressure were measured. Relative to placebo, treatment with dF was associated with significantly greater reductions in body weight (-3.8 kg), fat mass (-2.5 kg) and fat-free mass (-1.2 kg), Waist and hip circumferences also decreased but the waist:hip ratio remained unchanged. The ratio of waist:hip fat mass as measured by DEXA decreased more in the dF group. Lower total energy intake (-439 kJ/d) and fat intake (-5.1 g/d) were also seen but were of borderline statistical significance. After adjusting for changes in fat intake, dF treatment was associated with lower cholesterol and triglyceride concentrations. Twelve weeks following cessation of the treatment, the rate of weight gain was not significantly different between the dF and the placebo group (p < 0.01).