THE ADDITION OF DEXFENFLURAMINE TO FLUOXETINE IN THE TREATMENT OF OBESITY - A RANDOMIZED CLINICAL-TRIAL

Current evidence demonstrates that pharmacologic agents, alone or in c ombination produce short-term weight-loss and may remain effective for extended periods of time in obese patients. We have evaluated the wei ght loss of a selective inhibitor of serotonin uptake, fluoxetine, alo ne as compared with combined therapeutic trial with another serotonine rgic drug, dexfenfluramine. Thirty-three patients were randomly assign ed in a double-blind randomized clinical trial divided to two groups: Group I [Fluoxetine 40 mg and placebo (n=13)] and Group II [Fluoxetine 40 mg plus dexfenfluramine 15 mg at night (n=20)]. Both groups had a significant weight loss at the end of 8 months (Group I, mean +/- SEM 6.2 +/- 2.8 kg and Group II 13.4 +/- 6.3 kg, p < 0.05). Group II patie nts had a significantly greater weight loss as compared with Group I b oth in terms of mean weight loss in kg and BMI in kg/m(2). However sig nificance between Group I and II related to BMI mean values and weight mean values were only achieved after, respectively, 4 and 6 months of treatment, At laboratory level there was an elevation of HDL-choleste rol and lowering of serum lipids values (cholesterol and triglycerides ) in both groups. Side effects were relatively minor and no altered cl inical vital signs or abnormal laboratory values were observed, We con cluded that the combination of fluoxetine (daytime) and dexfenfluramin e (at night) may be more effective than fluoxetine alone In weight red uction although the small size of this study does not permit broad gen eralization.