Sibutramine plus meal replacement therapy for body weight loss and maintenance in obese patients.
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.


METHODS
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.


CONCLUSIONS
Sibutramine plus LCD with meal replacements and behavior modification is a safe and effective strategy for achieving and sustaining weight loss in obese patients.
Early
James L
JL
Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, 1010 N. Kansas Rd., Wichita, KS 67214-3199, USA. jearly@kumc.edu
Apovian
Caroline M
CM
Aronne
Louis J
LJ
Fernstrom
Madelyn H
MH
Frank
Arthur
A
Greenway
Frank L
FL
Heber
David
D
Kushner
Robert F
RF
Cwik
Kristine M
KM
Walch
Julia K
JK
Hewkin
Ann C
AC
Blakesley
Vicky
V
D000293:Adolescent; D000328:Adult; D000465:Algorithms; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D001521:Behavior Therapy; D003131:Combined Modality Therapy / Q000009:adverse effects; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D004038:Diet, Reducing; D005526:Food, Formulated; D006801:Humans; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy* / Q000188:drug therapy* / Q000378:metabolism / Q000517:prevention & control*; D010919:Placebos; D016037:Single-Blind Method; D015431:Weight Loss / Q000187:drug effects
D001067:Appetite Depressants; D003503:Cyclobutanes; D010919:Placebos; C058254:sibutramine