Long-term Maintenance of Weight Loss After a Very-Low-Calorie Diet: A Randomized Blinded Trial of the Efficacy and Tolerability of Sibutramine

Am J Med. 1999 Feb;106(2):179-84. doi: 10.1016/s0002-9343(98)00411-2.


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.

Patients and 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).

Conclusion: Following a very-low-calorie diet, sibutramine is effective in maintaining and improving weight loss for up to 1 year.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Appetite Depressants / adverse effects
  • Appetite Depressants / therapeutic use*
  • Cyclobutanes / adverse effects
  • Cyclobutanes / therapeutic use*
  • Diet, Reducing*
  • Double-Blind Method
  • Energy Intake*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Obesity / diet therapy*
  • Obesity / drug therapy*
  • Serotonin Uptake Inhibitors / adverse effects
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Treatment Outcome
  • Weight Loss / drug effects*


  • Appetite Depressants
  • Cyclobutanes
  • Serotonin Uptake Inhibitors
  • sibutramine