Tags

Type your tag names separated by a space and hit enter

Sibutramine plus meal replacement therapy for body weight loss and maintenance in obese patients.
Obesity (Silver Spring) 2007; 15(6):1464-72O

Abstract

OBJECTIVE

Our objective was to assess the efficacy and safety of sibutramine with a low-calorie diet (LCD) and commercial meal-replacement product in achieving weight loss and weight-loss maintenance in obese patients.

RESEARCH METHODS AND PROCEDURES

Eight U.S. centers recruited 148 obese patients for a 3-month comprehensive weight-loss therapy (Phase I) comprising daily sibutramine 10 mg + LCD (two Slim-Fast meal-replacement shakes, one low-calorie meal; total kcal/d = 1200-1500). Patients (N = 113) who lost > or =5% of initial body weight during Phase I were randomized for a 9-month period (Phase II) to daily sibutramine 15 mg + LCD (one meal-replacement shake; two low-calorie meals: total kcal/d approximately 1200-1500) or daily placebo + three low-calorie meals (total kcal/d approximately 1200-1500). Both phases included behavior modification. Efficacy was assessed by body weight change during each phase and by the number of patients at endpoint maintaining > or =80% of the weight they had lost by the end of Phase I. Other outcomes included changes in cardiovascular and metabolic risk factors, adverse events, and vital signs.

RESULTS

Mean body weight change during Phase I was -8.3 kg (p < 0.001). Patients randomized to sibutramine in Phase II had an additional -2.5 kg mean weight loss vs. a 2.8-kg increase in the placebo group (p < 0.001). More sibutramine patients maintained > or =80% of their Phase I weight loss at the end of Phase II (85.5% vs. placebo 36.7%, p < 0.001). Most adverse events were mild or moderate in severity, and all serious adverse events were unrelated to sibutramine.

DISCUSSION

Sibutramine plus LCD with meal replacements and behavior modification is a safe and effective strategy for achieving and sustaining weight loss in obese patients.

Authors+Show Affiliations

Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, 1010 N. Kansas Rd., Wichita, KS 67214-3199, USA. jearly@kumc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17557984

Citation

Early, James L., et al. "Sibutramine Plus Meal Replacement Therapy for Body Weight Loss and Maintenance in Obese Patients." Obesity (Silver Spring, Md.), vol. 15, no. 6, 2007, pp. 1464-72.
Early JL, Apovian CM, Aronne LJ, et al. Sibutramine plus meal replacement therapy for body weight loss and maintenance in obese patients. Obesity (Silver Spring). 2007;15(6):1464-72.
Early, J. L., Apovian, C. M., Aronne, L. J., Fernstrom, M. H., Frank, A., Greenway, F. L., ... Blakesley, V. (2007). Sibutramine plus meal replacement therapy for body weight loss and maintenance in obese patients. Obesity (Silver Spring, Md.), 15(6), pp. 1464-72.
Early JL, et al. Sibutramine Plus Meal Replacement Therapy for Body Weight Loss and Maintenance in Obese Patients. Obesity (Silver Spring). 2007;15(6):1464-72. PubMed PMID: 17557984.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sibutramine plus meal replacement therapy for body weight loss and maintenance in obese patients. AU - Early,James L, AU - Apovian,Caroline M, AU - Aronne,Louis J, AU - Fernstrom,Madelyn H, AU - Frank,Arthur, AU - Greenway,Frank L, AU - Heber,David, AU - Kushner,Robert F, AU - Cwik,Kristine M, AU - Walch,Julia K, AU - Hewkin,Ann C, AU - Blakesley,Vicky, PY - 2007/6/15/pubmed PY - 2007/9/5/medline PY - 2007/6/15/entrez SP - 1464 EP - 72 JF - Obesity (Silver Spring, Md.) JO - Obesity (Silver Spring) VL - 15 IS - 6 N2 - OBJECTIVE: Our objective was to assess the efficacy and safety of sibutramine with a low-calorie diet (LCD) and commercial meal-replacement product in achieving weight loss and weight-loss maintenance in obese patients. RESEARCH METHODS AND PROCEDURES: Eight U.S. centers recruited 148 obese patients for a 3-month comprehensive weight-loss therapy (Phase I) comprising daily sibutramine 10 mg + LCD (two Slim-Fast meal-replacement shakes, one low-calorie meal; total kcal/d = 1200-1500). Patients (N = 113) who lost > or =5% of initial body weight during Phase I were randomized for a 9-month period (Phase II) to daily sibutramine 15 mg + LCD (one meal-replacement shake; two low-calorie meals: total kcal/d approximately 1200-1500) or daily placebo + three low-calorie meals (total kcal/d approximately 1200-1500). Both phases included behavior modification. Efficacy was assessed by body weight change during each phase and by the number of patients at endpoint maintaining > or =80% of the weight they had lost by the end of Phase I. Other outcomes included changes in cardiovascular and metabolic risk factors, adverse events, and vital signs. RESULTS: Mean body weight change during Phase I was -8.3 kg (p < 0.001). Patients randomized to sibutramine in Phase II had an additional -2.5 kg mean weight loss vs. a 2.8-kg increase in the placebo group (p < 0.001). More sibutramine patients maintained > or =80% of their Phase I weight loss at the end of Phase II (85.5% vs. placebo 36.7%, p < 0.001). Most adverse events were mild or moderate in severity, and all serious adverse events were unrelated to sibutramine. DISCUSSION: Sibutramine plus LCD with meal replacements and behavior modification is a safe and effective strategy for achieving and sustaining weight loss in obese patients. SN - 1930-7381 UR - https://www.unboundmedicine.com/medline/citation/17557984/Sibutramine_plus_meal_replacement_therapy_for_body_weight_loss_and_maintenance_in_obese_patients_ L2 - https://doi.org/10.1038/oby.2007.175 DB - PRIME DP - Unbound Medicine ER -