DEXFENFLURAMINE ITALIAN MULTICENTER OPEN STUDY (DIMOS) - EFFICACY ANDSAFETY OF DEXFENFLURAMINE IN THE TREATMENT OF PATIENTS WITH SIMPLE ORCOMPLICATED OBESITY

The purpose of this study was to confirm the safety and efficacy of de xfenfluramine in association with a weight-stabilising diet in obese p atients. A total of 415 obese subjects received dexfenfluramine 15mg t wice daily for 3 months. These subjects were suffering from obesity wi th either no concomitant complications (n = 210) or the following conc omitant complications: hypertension (n = 59), non-insulin-dependent di abetes mellitus (NIDDM) [n = 86], eating disorders (n = 60). The demog raphic parameters and the parameters related to bodyweight in the vari ous subgroups were similar at the time of inclusion. After 3 months of dexfenfluramine treatment, the mean weight loss in the patients who h ad completed the study was as follows: simple obesity 5.7 +/- 0.3kg (n = 183); obesity with hypertension: 6.0 +/- 0.3kg (n = 57); obesity wi th NIDDM: 4.2 +/- 0.3kg (n = 78); obesity with eating disorders: 6.1 /- 0.4kg (n = 58). In the patients with obesity and hypertension, the mean systolic and diastolic pressures showed highly significant reduct ions (p < 0.001). In the patients with obesity and NIDDM, the fasting and postprandial blood glucose and glycosylated haemoglobin were also highly significantly reduced (p < 0.001). In the obese patients with e ating disorders, the mean total caloric intake was reduced by 36%, whi ch was highly significant (p < 0.001). The mean carbohydrate and fat i ntake was reduced by 35.4 and 37.9%, respectively (p < 0.001), whereas protein intake was only marginally reduced. Adverse events were usual ly moderate and transient, occurring at the beginning of treatment. Th e most common were drowsiness (6.3%), dry mouth (5.3%) and headaches ( 5.3%). This incidence was similar to that found in previous clinical t rials. In conclusion, dexfenfluramine induced significant weight loss in this group of obese patients, both with and without concomitant com plications. A concomitant improvement in diabetes and hypertension was observed in patients initially presenting with these complications. I n addition, dexfenfluramine improved the eating disorders that are fre quently responsible for overweight and had a selective effect on diet, essentially reducing carbohydrate and fat intake and not that of prot ein.