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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.
Eur J Clin Nutr. 2005 Aug; 59 Suppl 1:S31-8; discussion S39.EJ

Abstract

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+Show Affiliations

Mathus-Vliegen EM
Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. e.mathus-vliegen@amc.uva.nl
Balance Study Group
No affiliation info available

MeSH

AdultAppetite DepressantsCyclobutanesDiet, ReducingDouble-Blind MethodEnergy IntakeExerciseFemaleHumansLongitudinal StudiesMaleNetherlandsObesitySafetyTreatment OutcomeWeight Loss

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16052193

Citation

Mathus-Vliegen, E M H., and Balance Study Group. "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." European Journal of Clinical Nutrition, vol. 59 Suppl 1, 2005, pp. S31-8; discussion S39.
Mathus-Vliegen EM, Balance Study Group. 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. Eur J Clin Nutr. 2005;59 Suppl 1:S31-8; discussion S39.
Mathus-Vliegen, E. M. (2005). 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. European Journal of Clinical Nutrition, 59 Suppl 1, S31-8; discussion S39.
Mathus-Vliegen EM, Balance Study Group. 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. Eur J Clin Nutr. 2005;59 Suppl 1:S31-8; discussion S39. PubMed PMID: 16052193.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Mathus-Vliegen,E M H, AU - ,, PY - 2005/7/30/pubmed PY - 2005/10/29/medline PY - 2005/7/30/entrez SP - S31-8; discussion S39 JF - European journal of clinical nutrition JO - Eur J Clin Nutr VL - 59 Suppl 1 N2 - 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. SN - 0954-3007 UR - https://www.unboundmedicine.com/medline/citation/16052193/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_ DB - PRIME DP - Unbound Medicine ER -