Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity

J Fam Pract. 2001 Jun;50(6):505-12.


Objective: The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity.

Study design: This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice.

Population: A total of 485 obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2).

Outcomes measured: The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects.

Results: Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg for those taking sibutramine 10 mg (P < or =.01, last observation carried forward [LOCF]), and -6.4 kg for those taking sibutramine 15 mg (P < or =.001, LOCF). For placebo patients, 20% lost 5% or more of their body weight compared with 39% of patients taking sibutramine 10 mg and 57% taking sibutramine 15 mg. Only 7% of the patients taking placebo lost 10% or more of their body weight, compared with 19% taking sibutramine 10 mg and 34% taking sibutramine 15 mg (P <.001 for both 10 mg and 15 mg vs placebo, and for both > or =5% and > or =10%).

Conclusions: Sibutramine 10 mg or 15 mg once daily given with dietary advice produces and maintains statistically and clinically significantly greater weight loss than dietary advice alone (placebo) throughout a 12-month treatment period, and is safe and well tolerated.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Appetite Depressants / pharmacology
  • Appetite Depressants / therapeutic use*
  • Behavior Therapy
  • Body Mass Index
  • Body Weight / drug effects
  • Combined Modality Therapy
  • Cyclobutanes / pharmacology
  • Cyclobutanes / therapeutic use*
  • Double-Blind Method
  • Family Practice
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nutritional Physiological Phenomena
  • Obesity / classification
  • Obesity / diagnosis
  • Obesity / drug therapy*
  • Placebos
  • Primary Health Care
  • Selective Serotonin Reuptake Inhibitors / pharmacology
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*
  • Severity of Illness Index
  • Treatment Outcome
  • Weight Loss / drug effects


  • Appetite Depressants
  • Cyclobutanes
  • Placebos
  • Serotonin Uptake Inhibitors
  • sibutramine