期刊
EUROPEAN JOURNAL OF CLINICAL NUTRITION
卷 59, 期 -, 页码 S31-S38出版社
SPRINGERNATURE
DOI: 10.1038/sj.ejcn.1602172
关键词
very-low-calorie-diet (VLCD); sibutramine; weight loss treatment; weight loss management; general practice
Objective: Very-low-calorie diets (VLCDs) are used to promote short-term weight loss in obese patients. However, long-term maintenance of weight loss is generally poor. We assessed the efficacy and safety of sibutramine in maintaining weight loss achieved in obese patients by means of a 3-month VLCD. Design: A multicenter double-blind, parallel-group trial conducted over 18 months, following a 3-month open label VLCD run-in. Setting: Eight hospital centers in The Netherlands, with subsequent follow-up in general practice. Subjects: A total of 221 obese subjects, of whom 189 were randomized (mean screening BMI 36.6 kg/m(2); mean age 42.6y). Measurements: Patients were given a 3-month VLCD and were required to lose 10% or more of their initial weight. A total of 189 patients completed this phase (mean percentage weight loss 14.5 +/- 3.2%) and were randomized to sibutramine 10 mg/day (n = 94) or matching placebo (n = 95). All patients received a recommended diet and exercise program. The primary analysis was outcome in terms of achieving 80% weight maintenance of the VLCD period at month 18. Secondary analysis was percentage of initial weight loss maintained at months 6, 12, 18 and end point.
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