Document Detail


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.
MedLine Citation:
PMID:  16052193     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 42.6 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. RESULTS: At month 18, the odds ratio for achieving successful weight maintenance was 1.76 (95% CI 1.06, 2.93) in favor of sibutramine (P=0.03). In intention-to-treat analysis, more than 80% of the weight loss achieved during the VLCD phase was maintained by 70, 51 and 30% of sibutramine-treated patients at months 6, 12 and 18, respectively, compared to 48, 31 and 20% of placebo-treated patients. The differences between the treatment groups were significant (P< or =0.03) at all time points. CONCLUSION: Weight loss achieved with a VLCD is more effectively maintained with sibutramine in combination with a recommended diet and exercise program than with placebo over a follow-up period of 18 months. Sibutramine is well tolerated, with a safety profile consistent with that seen in other previous trials.
Authors:
E M H Mathus-Vliegen;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of clinical nutrition     Volume:  59 Suppl 1     ISSN:  0954-3007     ISO Abbreviation:  Eur J Clin Nutr     Publication Date:  2005 Aug 
Date Detail:
Created Date:  2005-07-29     Completed Date:  2005-10-28     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8804070     Medline TA:  Eur J Clin Nutr     Country:  England    
Other Details:
Languages:  eng     Pagination:  S31-8; discussion S39     Citation Subset:  IM    
Affiliation:
Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. e.mathus-vliegen@amc.uva.nl
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MeSH Terms
Descriptor/Qualifier:
Adult
Appetite Depressants / adverse effects,  therapeutic use*
Cyclobutanes / adverse effects,  therapeutic use*
Diet, Reducing*
Double-Blind Method
Energy Intake
Exercise / physiology*
Female
Humans
Longitudinal Studies
Male
Netherlands
Obesity / diet therapy,  drug therapy,  therapy*
Safety
Treatment Outcome
Weight Loss / drug effects
Chemical
Reg. No./Substance:
0/Appetite Depressants; 0/Cyclobutanes; 106650-56-0/sibutramine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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