Clinical Experiences
| Effect of Sibutramine on Weight Maintenance After Weight Loss: A Randomised Trial - W Philip T James, Arne Astrup, Nick Finer, Jannik Hilsted, Peter Kopeman, Stephan Rössner, Wim H M saris, Luc F Van Gaal The Lancet, 2000; 356: 2119 -2125. |
| Background: Sibutramine - a tertiary amine has shown to enhance the effects of a low-calorie diet and induce dose-dependent weight loss for up to a year. A study was therefore carried out to assess the usefulness of sibutramine in maintaining substantial weight loss over 2 years.
Study Objective: To assess the the usefulness of sibutramine in maintaining substantial weight loss over two years. Study Design And Schedule: Six hundred and five obese patients (body-mass index 30-45 kg/m2 ) were recruited for a six month period of weight loss with sibutramine (10 mg/day) and an 600 kcal/day deficit programme based on measured resting metabolic rates. Patients with more than 5% weight loss were then randomly assigned 10 mg/day sibutramine (n=352) or placebo (n=115) for a further period of 18 months. In case of weight regain sibutramine was increased to 20 mg/day. The primary aim of the study was to measure at year 2 the number of patients under study who maintained at least 80% of the weight loss between baseline and month 6. The secondary aim was to observe changes in uric acid concentrations and glycaemic and lipid variables. Analysis was by intention to treat. Results: Of the 467 (77%) patients enrolled in the study 204 sibutramine-treated individuals and 57 individuals on placebo completed the trial. Among the 204 sibutramine-treated individuals who completed the study 89(43%) maintained 80% 80% or more of their original weight loss, compared with nine (16%) of the placebo group (odds ratio 4.64 p<0.001). There was a substantial decrease over the past 6 months, in triglycerides, VLDL cholesterol, insulin, C peptide and uric acid in patients; these changes were sustained in the in the sibutramine group but not in the placebo group. HDL cholesterol concentrations rose in the second year . The overall increase observed was 20.7% (sibutramine) and 11.7% placebo (p<0.001). In the sibutramine group, systolic blood pressure rose from from baseline to 2 years by 0.1 mm Hg (SD12.9), diastolic blood pressure by 2.3 Hg (9.4), and pulse rate by 4.1beats/min (11.9). 20 (3%) patients were withdrawn because of increases in blood pressure. Conclusion: A significant weight loss was observed in 77% of obese patients in this individualized management programme and sustained weight loss in most patients continuing therapy for 2 years. Changes in concentrations of HDL cholesterol, VLDL cholesterol and triglyceride, but not LDL cholesterol, exceed those expected from weight loss alone or when induced by other selective therapies for low concentrations of HDL cholesterol relating to coronary heart disease. |
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