Effect of sibutramine on weight maintenance after weight loss: a randomised trial.

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Title: Effect of sibutramine on weight maintenance after weight loss: a randomised trial.
Authors: James, W Philip T, Astrup, Arne, Finer, Nick, Hilsted, Jannik, Kopelman, Peter, Rossner, Stephan, Saris, Wim HM, Van Gaal, Luc F
Source: Lancet. 12/23/2000, Vol. 356 Issue 9248, p2119. 7p. 1 Diagram, 5 Charts, 3 Graphs.
Subjects: Sibutramine, Weight loss, Obesity, Hypercholesteremia treatment
Geographic Terms: Europe
Abstract: 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<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0.001). 20 (3%) patients were withdrawn because of increases in blood pressure; in the sibutramine group, systolic blood pressure rose from baseline to 2 years by 0.1 mm Hg (SD 12.9), diastolic blood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... [ABSTRACT FROM AUTHOR]
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  Data: Effect of sibutramine on weight maintenance after weight loss: a randomised trial.
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  Data: &lt;searchLink fieldCode=&quot;JN&quot; term=&quot;%22Lancet%22&quot;&gt;Lancet&lt;/searchLink&gt;. 12/23/2000, Vol. 356 Issue 9248, p2119. 7p. 1 Diagram, 5 Charts, 3 Graphs.
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  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Sibutramine%22&quot;&gt;Sibutramine&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Weight+loss%22&quot;&gt;Weight loss&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Obesity%22&quot;&gt;Obesity&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Hypercholesteremia+treatment%22&quot;&gt;Hypercholesteremia treatment&lt;/searchLink&gt;
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  Data: 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&lt;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&lt;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... [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1016/S0140-6736(00)03491-7
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      – Code: eng
        Text: English
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        PageCount: 7
        StartPage: 2119
    Subjects:
      – SubjectFull: Sibutramine
        Type: general
      – SubjectFull: Weight loss
        Type: general
      – SubjectFull: Obesity
        Type: general
      – SubjectFull: Hypercholesteremia treatment
        Type: general
      – SubjectFull: Europe
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      – TitleFull: Effect of sibutramine on weight maintenance after weight loss: a randomised trial.
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              Text: 12/23/2000
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