Long-term changes of body weight and cardiovascular risk factors after weight reduction with group therapy and dexfenfluramine.

The aim of this work was to investigate the long-term changes of body weight and cardiovascular risk factors after weight reduction with dexfenfluramine (dF) compared to placebo (pI) and additional group therapy. There was a 3 year follow-up of obese patients after 1 year double-blind, randomized treatment with 30mg dF or pI and group therapy. The work was carried out at the outpatient clinic of University Hospital, Tübingen. Forty-eight (24 dF, 24 pI) patients were investigated with more than 120% of ideal body weight. Body weight, blood pressure, blood glucose, serum cholesterol and triglycerides were measured. During 1 year of treatment body weight fell by 11.2% (dF) and 9.1% (pI) (P < 0.001 for time, n.s. for dF/pI), systolic blood pressure by 7.3 and 9.9 mm Hg (P = 0.044/n.s.). There were no significant changes of serum cholesterol, triglycerides, and blood glucose. At the follow-up of 22 (11/11) patients 3 years later, the dF group had regained more than the lost weight; the placebo group had lost 2.4% of the initial body weight. Serum cholesterol (dF + 0.64/pI + 0.65 mmol/l, P = 0.010/n.s.), triglycerides (+0.74/+0.59 mmol/l, P = 0.002/n.s.), and blood glucose (+0.56/+0.81mmol/l, P < 0.001/n.s.) increased significantly. Systolic blood pressure increased slightly, diastolic blood pressure did not change significantly. Without appropriate prevention of weight regain even combined weight reduction therapy over a period of one year results in weight regain and deterioration of cardiovascular risk factors.

RCT Entities:   Population Interventions Outcomes