Effect of sibutramine on weight maintenance after weight loss: a randomised trial
| Autor: | James, W.P.T., Astrup, A.V., Finer, N., Hilsted, J., Kopelman, P., Rossner, S., Saris, W.H.M., van Gaal, L.F., the STORM Study, Group |
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| Přispěvatelé: | Humane Biologie, RS: NUTRIM School of Nutrition and Translational Research in Metabolism |
| Jazyk: | angličtina |
| Rok vydání: | 2000 |
| Předmět: |
medicine.medical_specialty
Intention-to-treat analysis Tertiary amine business.industry Cholesterol General Medicine Placebo medicine.disease Obesity Surgery law.invention chemistry.chemical_compound chemistry Randomized controlled trial Weight loss law Internal medicine medicine medicine.symptom business Sibutramine medicine.drug |
| Zdroj: | The lancet : international edition Lancet, 23-30(356), 2119-2125. Elsevier Science |
| ISSN: | 0140-6736 |
| Popis: | Summary Background Sibutramine is a tertiary amine that has been shown to induce dose-dependent weight loss and to enhance the effects of a low-calorie diet for up to a year. We did a randomised, double-blind trial to assess the usefulness of sibutramine in maintaining substantial weight loss over 2 years. Methods Eight European centres recruited 605 obese patients (body-mass index 30-45 kg/m 2 ) 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 Interpretation This individualised management programme achieved weight loss in 77% of obese patients 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 either from weight loss alone or when induced by other selective therapies for low concentrations of HDL cholesterol relating to coronary heart disease. |
| Databáze: | OpenAIRE |
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