Effects of sibutramine plus orlistat in obese women following 1 year of treatment by sibutramine alone: A placebo-controlled trial

Objective: This study assessed whether adding orlistat to sibutramine would induce further weight loss in patients who previously had lost weight whil e taking sibutramine alone. Research Methods and Procedures: Patients were 34 women with a mean age of 44.1 +/- 10.4 years, weight of 89.4 +/- 13.8 kg, and body mass index (BMI) of 33.9 +/- 4.9 kg/m(2) who had lost an average of 11.6 +/- 9.2% of initial weight during the prior 1 year of treatment by sibutramine combined with l ifestyle modification. Patients were randomly assigned, in double-blind fas hion, to sibutramine plus orlistat or sibutramine plus placebo. In addition to medication, participants were provided five brief lifestyle modificatio n visits during the 16-week continuation trial. Results: Mean body weight did not change significantly in either treatment condition during the 16 weeks. The addition of orlistat to sibutramine did not induce further weight loss as compared with treatment by sibutramine al one (mean changes = +0.1 +/- 4.1 kg vs. +0.5 +/- 2.1 kg, respectively). Discussion: These results must be interpreted with caution because of the s tudy's small sample size. The findings, however, suggest that the combinati on of sibutramine and orlistat is unlikely to have additive effects that wi ll yield mean losses greater than or equal to 15% of initial weight, as des ired by many obese individuals.