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>Dexfenfluramine Italian Multicentre Open Study (DIMOS)Efficacy and Safety of Dexfenfluramine in the Treatment of Patients with Simple or Complicated Obesity
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Dexfenfluramine Italian Multicentre Open Study (DIMOS)Efficacy and Safety of Dexfenfluramine in the Treatment of Patients with Simple or Complicated Obesity
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机译：Dexfenfluramine Italian Multicentre Open Study (DIMOS)Efficacy and Safety of Dexfenfluramine in the Treatment of Patients with Simple or Complicated Obesity
The purpose of this study was to confirm the safety and efficacy of dexfenfluramine in association with a weight-stabilising diet in obese patients. A total of 415 obese subjects received dexfenfluramine 15mg twice daily for 3 months. These subjects were suffering from obesity with either no concomitant complications (n equals; 210) or the following concomitant complications: hypertension (n equals; 59), non-insulin-dependent diabetes mellitus (NIDDM) lsqb;n equals; 86rsqb;, eating disorders (n equals; 60). The demographic parameters and the parameters related to bodyweight in the various subgroups were similar at the time of inclusion. After 3 months of dexfenfluramine treatment, the mean weight loss in the patients who had completed the study was as follows: simple obesity 5.7 plusmn; 0.3kg (n equals; 183); obesity with hypertension: 6.0 plusmn; 0.3kg (n equals; 57); obesity with NIDDM: 4.2 plusmn; 0.3kg (n equals; 78); obesity with eating disorders: 6.1 plusmn; 0.4kg (n equals; 58). In the patients with obesity and hypertension, the mean systolic and diastolic pressures showed highly significant reductions (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 eating disorders, the mean total caloric intake was reduced by 36percnt;, which was highly significant (p 0.001). The mean carbohydrate and fat intake was reduced by 35.4 and 37.9percnt;, respectively (p 0.001), whereas protein intake was only marginally reduced. Adverse events were usually moderate and transient, occurring at the beginning of treatment. The most common were drowsiness (6.3percnt;), dry mouth (5.3percnt;) and headaches (5.3percnt;). This incidence was similar to that found in previous clinical trials. In conclusion, dexfenfluramine induced significant weight loss in this group of obese patients, both with and without concomitant complications. A concomitant improvement in diabetes and hypertension was observed in patients initially presenting with these complications. In addition, dexfenfluramine improved the eating disorders that are frequently responsible for overweight and had a selective effect on diet, essentially reducing carbohydrate and fat intake and not that of protein.
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