Long-term maintenance of weight loss with sibutramine in a GP setting following a specialist guided very-low-calorie diet: a double-blind, placebo-controlled, parallel group study

• Published in: European journal of clinical nutrition Vol. 59; no. Suppl 1; pp. S31 - S39
• Main Author: Mathus, E M H
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.08.2005; Nature Publishing Group
• Subjects: Adult; adults; Analysis; Appetite Depressants - adverse effects; Appetite Depressants - therapeutic use; Body weight loss; Clinical Nutrition; Clinical trials; Cyclobutanes - adverse effects; Cyclobutanes - therapeutic use; Diet; Diet, Reducing; Double-Blind Method; Double-blind studies; Drug therapy; Energy Intake; Epidemiology; Exercise - physiology; Family medicine; Female; general practitioners; Humans; Hypocaloric diet; Internal Medicine; Long term; long term experiments; Longitudinal Studies; Maintenance; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Metabolic Diseases; Netherlands; Nutrient deficiency; Obesity; Obesity - diet therapy; Obesity - drug therapy; Obesity - therapy; original-communication; Patients; Physicians; Physicians (General practice); Placebo effect; Placebos; Public Health; Safety; Secondary analysis; Sibutramine; Single group studies; Specialists; Treatment Outcome; very low calorie diet; Weight control; Weight loss; Weight Loss - drug effects; Weight reducing preparations; Netherlands; sibutramine; weight loss treatment; weight loss management; very-low-calorie-diet (VLCD); general practice
• ISSN: 0954-3007; 1476-5640
• DOI: 10.1038/sj.ejcn.1602172

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/m2; mean age 42.6 y). 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.