Dexenfluramine, an effective and safe serotoninergic
drug with
anorectic and possible food-selection-tuning properties, was investigated in a placebo-controlled study of 1 year's duration in severe and refractory
obesity. The aim of the study was to assess
weight loss, and changes in cardiovascular risk factors, food intake and eating behaviour.
Dexfenfluramine- and placebo-treated patients achieved a similar
weight loss (greater than 10% of initial weight, by 39.5 and 30.0%, greater than 20% of initial
overweight by 42.1% and 32.5% and greater than 10 kg by 41.4 and 33.3%, respectively, of the initial cohorts). Furthermore, the decreases in weight (10.7 vs. 8.0 kg), in body mass index (3.9 vs. 2.9 kg m2) and in waist/hip ratio (0.04 vs. 0.02) were not significantly different. After discontinuation of the
drug, the increase in weight (2.8 vs. 1.0 kg) was significantly higher in the
dexfenfluramine-treated group. Except for a borderline better effect on
glucose of
dexfenfluramine, both groups showed similar beneficial changes in food intake and cardiovascular risk factors. Eating behaviour in response to emotional and external stimuli was comparable in the two groups, but placebo-treated patients had to restrain their eating more in order to achieve the same
weight loss. Notwithstanding the fact that
weight losses and an associated amelioration of health-risk factors were of similar magnitude in
dexfenfluramine- and placebo-treated patients,
dexfenfluramine might have a useful role in promoting a less stressed adherence to prolonged restriction of energy intake in the severe and refractory obese subject.