Abstract | BACKGROUND: METHODS: Eight European centres recruited 605 obese patients (body-mass index 30-45 kg/m2) for a 6-month period of weight loss with sibutramine (10 mg/day) and an individualised 600 kcal/day deficit programme based on measured resting metabolic rates. 467 (77%) patients with more than 5% weight loss were then randomly assigned 10 mg/day sibutramine (n=352) or placebo (n=115) for a further 18 months. Sibutramine was increased up to 20 mg/day if weight regain occurred. The primary outcome measure was the number of patients at year 2 maintaining at least 80% of the weight lost between baseline and month 6. Secondary outcomes included changes in uric acid concentrations and glycaemic and lipid variables. Analysis was by intention to treat. FINDINGS: 148 (42%) individuals in the sibutramine group and 58 (50%) in the placebo group dropped out. Of the 204 sibutramine-treated individuals who completed the trial, 89 (43%) maintained 80% or more of their original weight loss, compared with nine (16%) of the 57 individuals in the placebo group (odds ratio 4.64, p<0.001). Patients had substantial decreases over the first 6 months with respect to triglycerides, VLDL cholesterol, insulin, C peptide, and uric acid; these changes were sustained in the sibutramine group but not the placebo group. HDL cholesterol concentrations rose substantially in the second year: overall increases were 20.7% ( sibutramine) and 11.7% (placebo, p<0.001). 20 (3%) patients were withdrawn because of increases in blood pressure; in the sibutramine group, systolic blood pressure rose from baseline to 2 years by 0.1 mm Hg (SD 12.9), diastolic blood pressure by 2.3 mm Hg (9.4), and pulse rate by 4.1 beats/min (11.9). INTERPRETATION:
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Authors | W P James, A Astrup, N Finer, J Hilsted, P Kopelman, S Rössner, W H Saris, L F Van Gaal |
Journal | Lancet (London, England)
(Lancet)
2000 Dec 23-30
Vol. 356
Issue 9248
Pg. 2119-25
ISSN: 0140-6736 [Print] England |
PMID | 11191537
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Appetite Depressants
- Cyclobutanes
- sibutramine
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Topics |
- Adolescent
- Adult
- Aged
- Appetite Depressants
(therapeutic use)
- Cyclobutanes
(therapeutic use)
- Diet, Reducing
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Logistic Models
- Male
- Metabolism
(drug effects)
- Middle Aged
- Obesity
(prevention & control)
- Secondary Prevention
- Weight Loss
(drug effects)
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