A clinical study with dexfenfluramine (d F) in obese patients is presented. in this randomized double blind placebo controlled trial it has been shown that dF is an efficient weight lowering agent, inducing weight loss largely greater than those seen with placebo. 45 obese patients (body mass index (BMI): 28-35 kg/m2) were included in the study. Either dF, 15 mg twice daily (25) or placebo (20) was given in addition to a calorie restricted diet, for 12 weeks. Patients in both groups had significant weight loss. Weight loss was 5.2+2.5 kg in the dF group, 2.67±2.96 kg in placebo group. The difference between the groups was significant (p < 0.05). The decrease in BMI in each group was also significant as well as the difference between groups. More than halt of the patients in the dF group considered the treatment as "good" whereas no one from the placebo group thought that the quality of life with the drug was good. Acceptability of the drug was 94 % in the dF group whereas it remained at 36 % for the placebo group. More patients in the dF group followed the diet and more patients in the dF group complained of adverse events only in the first month of the treatment. Side effects were short lived and occurred early in the study.
Keywords: Dexfenfluramine, obesity, weight loss