The Long-term Outcomes of Sibutramine Effectiveness on Weight (LOSE Weight) study: evaluating the role of drug therapy within a weight management program in a group-model health maintenance organization.
OBJECTIVE
To assess the benefit of sibutramine hydrochloride monohydrate within a weight management program.


METHODS
Prospective randomized controlled trial in a health maintenance organization.


METHODS
Obese patients (n = 588) starting a weight management program were enrolled. Patients were randomly assigned to participate in the program alone or to participate in the program and receive sibutramine for 12 months. Outcome measures were change in weight, body mass index (BMI), percentage body fat, serum lipids, serum glucose, and blood pressure.


RESULTS
At baseline, there was a younger age and higher weight, BMI, and waist circumference in the drug group. There was more degenerative joint disease in the nondrug group. The mean weight loss at 6 months was 6.8 kg (95% confidence interval [CI], -7.4 to -6.1 kg) in the drug group vs 3.1 kg (95% CI, -3.8 to -2.4 kg) (P < .001) in the nondrug group. Weight loss was maintained at 12 months. Significant reductions in BMI, body fat, and waist circumference occurred in the drug group. There were no significant changes in laboratory values or blood pressure. Patients taking sibutramine experienced a significant increase in heart rate (1.7 beats/min [95% CI, 0.5-2.9 beats/min] vs -0.4 beats/min [95% CI, -1.5 to 0.8 beats/min]; P <.004).


CONCLUSIONS
In this managed care setting, the effectiveness and safety of sibutramine were similar to those observed in randomized, double-blind clinical efficacy trials.
Porter
Julie A
JA
Aventis Pharmaceuticals, Inc, Bridgewater, NJ 08807, USA. julie.porter@aventis.com
Raebel
Marsha A
MA
Conner
Douglas A
DA
Lanty
Frances A
FA
Vogel
Erin A
EA
Gay
Elizabeth C
EC
Merenich
John A
JA
D000328:Adult; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D003120:Colorado; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D019468:Disease Management; D005260:Female; D006279:Health Maintenance Organizations / Q000458:organization & administration*; D006302:Health Services Research; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D016896:Treatment Outcome
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine