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Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study.
Exp Clin Endocrinol Diabetes 2004; 112(4):201-7EC

Abstract

BACKGROUND

Sibutramine is a selective serotonin and noradrenaline reuptake inhibitor that is known to reduce body weight. The efficacy of this drug in primary care medicine is currently unknown.

OBJECTIVE

To study, in a primary healthcare setting, the effect of a standardized non-pharmacological treatment program and 15 mg sibutramine or placebo on long-term weight reduction in obese subjects with a body mass index >or= 30 and < 40 kg/m(2).

DESIGN

A multicentre, double-blind, placebo-controlled, randomized, parallel group comparison over 54 weeks of continuous therapy.

SETTING

33 general practitioners in Germany.

SUBJECTS

389 obese patients were recruited of whom 362 were randomized.

MEASUREMENTS

Primary measure was weight reduction at week 54; others included reduction in BMI, waist circumference, waist-hip ratio, blood pressure and blood lipids.

RESULTS

348 obese subjects were analyzed using an intention-to-treat analysis. Mean weight loss in the sibutramine (S) group was 8.1 +/- 8.2 kg vs. 5.1 +/- 6.5 kg in the placebo (P) group (p < 0.001; Intent-to-treat analysis). More subjects lost more than 5 % and 10 % of initial weight with sibutramine than with placebo (5 %, S: 62.6 %, P: 41.4 %, p < 0.001; 10 %, S: 40.8, P: 19.0 %, p < 0.001). Weight loss was accompanied by an improvement in the lipid profile, in particular, an increase in HDL-cholesterol and a decrease in fasting triglycerides. In both groups, systolic and diastolic blood pressure decreased in those with moderate hypertension and remained unchanged in those with normal blood pressure at baseline. There was a modest increase in heart rate in S (1.9 beats/min) vs. P (- 0.9 beats/min) (p < 0.05).

CONCLUSIONS

Under primary care conditions, sibutramine 15 mg daily proved to be a safe and effective drug for additional weight loss in obese subjects undergoing a comprehensive weight reduction program.

Authors+Show Affiliations

German Diabetes Research Institute, Düsseldorf, Germany. Hauner@wzw.tum.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15127325

Citation

Hauner, H, et al. "Weight Reduction By Sibutramine in Obese Subjects in Primary Care Medicine: the SAT Study." Experimental and Clinical Endocrinology & Diabetes : Official Journal, German Society of Endocrinology [and] German Diabetes Association, vol. 112, no. 4, 2004, pp. 201-7.
Hauner H, Meier M, Wendland G, et al. Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study. Exp Clin Endocrinol Diabetes. 2004;112(4):201-7.
Hauner, H., Meier, M., Wendland, G., Kurscheid, T., & Lauterbach, K. (2004). Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study. Experimental and Clinical Endocrinology & Diabetes : Official Journal, German Society of Endocrinology [and] German Diabetes Association, 112(4), pp. 201-7.
Hauner H, et al. Weight Reduction By Sibutramine in Obese Subjects in Primary Care Medicine: the SAT Study. Exp Clin Endocrinol Diabetes. 2004;112(4):201-7. PubMed PMID: 15127325.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study. AU - Hauner,H, AU - Meier,M, AU - Wendland,G, AU - Kurscheid,T, AU - Lauterbach,K, AU - ,, AU - ,, PY - 2004/5/6/pubmed PY - 2004/12/16/medline PY - 2004/5/6/entrez SP - 201 EP - 7 JF - Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association JO - Exp. Clin. Endocrinol. Diabetes VL - 112 IS - 4 N2 - BACKGROUND: Sibutramine is a selective serotonin and noradrenaline reuptake inhibitor that is known to reduce body weight. The efficacy of this drug in primary care medicine is currently unknown. OBJECTIVE: To study, in a primary healthcare setting, the effect of a standardized non-pharmacological treatment program and 15 mg sibutramine or placebo on long-term weight reduction in obese subjects with a body mass index >or= 30 and < 40 kg/m(2). DESIGN: A multicentre, double-blind, placebo-controlled, randomized, parallel group comparison over 54 weeks of continuous therapy. SETTING: 33 general practitioners in Germany. SUBJECTS: 389 obese patients were recruited of whom 362 were randomized. MEASUREMENTS: Primary measure was weight reduction at week 54; others included reduction in BMI, waist circumference, waist-hip ratio, blood pressure and blood lipids. RESULTS: 348 obese subjects were analyzed using an intention-to-treat analysis. Mean weight loss in the sibutramine (S) group was 8.1 +/- 8.2 kg vs. 5.1 +/- 6.5 kg in the placebo (P) group (p < 0.001; Intent-to-treat analysis). More subjects lost more than 5 % and 10 % of initial weight with sibutramine than with placebo (5 %, S: 62.6 %, P: 41.4 %, p < 0.001; 10 %, S: 40.8, P: 19.0 %, p < 0.001). Weight loss was accompanied by an improvement in the lipid profile, in particular, an increase in HDL-cholesterol and a decrease in fasting triglycerides. In both groups, systolic and diastolic blood pressure decreased in those with moderate hypertension and remained unchanged in those with normal blood pressure at baseline. There was a modest increase in heart rate in S (1.9 beats/min) vs. P (- 0.9 beats/min) (p < 0.05). CONCLUSIONS: Under primary care conditions, sibutramine 15 mg daily proved to be a safe and effective drug for additional weight loss in obese subjects undergoing a comprehensive weight reduction program. SN - 0947-7349 UR - https://www.unboundmedicine.com/medline/citation/15127325/Weight_reduction_by_sibutramine_in_obese_subjects_in_primary_care_medicine:_the_SAT_Study_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-2004-817934 DB - PRIME DP - Unbound Medicine ER -