Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine.
BACKGROUND
Very-low-calorie diets are a well established method to achieve substantial short-term weight loss in obese patients, but long-term maintenance of the weight loss is very disappointing. A combined very-low-calorie diet and pharmacologic approach could be an effective means of prolonging its benefits.


METHODS
Eligible patients had a body-mass index greater than 30 kg/m2; those who lost 6 kg or more during a 4-week treatment with a very-low-calorie diet were randomly assigned to 1 year of treatment with sibutramine (10 mg) or identical placebo.


RESULTS
In an intention-to-treat analysis, mean (+/-SD) absolute weight change at 1 year (or study endpoint) was -5.2 (+/-7.5) kg in the 81 patients in the sibutramine group and +0.5 (+/-5.7) kg in the 78 patients in the placebo group (P = 0.004). When compared with their weight at study entry (before the very-low-calorie diet), 86% of patients in the sibutramine group had lost at least 5% of their weight, compared with only 55% of those in the placebo group (P <0.001) at the study endpoint. Similarly, at month 12, 75% of subjects in the sibutramine group maintained at least 100% of the weight loss achieved with a very-low-calorie diet, compared with 42% in the placebo group (P <0.01).


CONCLUSIONS
Following a very-low-calorie diet, sibutramine is effective in maintaining and improving weight loss for up to 1 year.
Apfelbaum
M
M
Nutrition Department, Bichat Hospital, Paris, France.
Vague
P
P
Ziegler
O
O
Hanotin
C
C
Thomas
F
F
Leutenegger
E
E
D000328:Adult; D001067:Appetite Depressants / Q000009:adverse effects / Q000627:therapeutic use*; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D004038:Diet, Reducing; D004311:Double-Blind Method; D002149:Energy Intake; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy* / Q000188:drug therapy*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects*
D001067:Appetite Depressants; D003503:Cyclobutanes; D017367:Selective Serotonin Reuptake Inhibitors; C058254:sibutramine