As successful weight management demands a long term approach, a better understanding of weight changes during and for significant periods after cessation of
dexfenfluramine therapy is essential to the evaluation of the
drug's effectiveness in clinical practice. This study aimed to investigate additional benefits to
weight loss during 6 months treatment with
dexfenfluramine in 60 patients enrolled in a
weight loss programme.
DESIGN: Sixty obese subjects (21 males; 39 females) were randomised to
dexfenfluramine (15 mg twice daily) or placebo for six months. Fifty one (27
dexfenfluramine; 24 placebo) subjects completed the double blind, randomised, placebo controlled clinical trial.
RESULTS: After a one month 'run in' phase and six months treatment,
weight loss in the
dexfenfluramine group was significantly greater than placebo, 9.7 +/- 1.1 kg vs 4.9 +/- 0.9 kg (mean +/- s.e.m.); P = 0.002. Reduction in body fat, 5.0 +/- 0.7 kg vs 1.0 +/- 0.9 kg; P = 0.002 and waist circumference, 10.5 +/- 1.9 cm vs 5.7 +/- 1.1 cm; P = 0.04 was also greater in the
dexfenfluramine group. Despite significant
weight loss, waist to hip ratio (WHR) did not change in either group. The
dexfenfluramine group reported a significantly greater incidence of
nausea, dry mouth and
dizziness which tended to decrease as treatment progressed. No subjects withdrew due to
drug induced side effects. Reduction in serum
triglyceride levels and an increase in
HDL cholesterol (in female subjects) in conjunction with a reduction in fasting
insulin, collectively support an improved cardiovascular risk profile in the
dexfenfluramine group. Despite significant
weight loss, these risk factor measurements worsened in the placebo group. After cessation of
dexfenfluramine therapy, there was a significantly greater weight regain indicating a loss of treatment effect. By 5 months after cessation of
dexfenfluramine, the treatment effect was negated with
weight loss in the
dexfenfluramine (6.0 +/- 1.6 kg) and placebo (6.2 +/- 1.3 kg) group, similar.
CONCLUSION: