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 while taking sibutramine alone.


METHODS
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/m2 who had lost an average of 11.6 +/- 9.2% of initial weight during the prior 1 year of treatment by sibutramine combined with lifestyle modification. Patients were randomly assigned, in double-blind fashion, to sibutramine plus orlistat or sibutramine plus placebo. In addition to medication, participants were provided five brief lifestyle modification 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 alone (mean changes = +0.1 +/- 4.1 kg vs. +0.5 +/- 2.1 kg, respectively).


CONCLUSIONS
These results must be interpreted with caution because of the study's small sample size. The findings, however, suggest that the combination of sibutramine and orlistat is unlikely to have additive effects that will yield mean losses > or =15% of initial weight, as desired by many obese individuals.
Wadden
T A
TA
University of Pennsylvania School of Medicine, Department of Psychiatry, Philadelphia 19104, USA. wadden@mail.med.upenn.edu
Berkowitz
R I
RI
Womble
L G
LG
Sarwer
D B
DB
Arnold
M E
ME
Steinberg
C M
CM
D000328:Adult; D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001067:Appetite Depressants / Q000008:administration & dosage / Q000627:therapeutic use*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D003131:Combined Modality Therapy; D003503:Cyclobutanes / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000627:therapeutic use*; D008019:Life Style; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000517:prevention & control; D000077403:Orlistat; D010865:Pilot Projects; D013997:Time Factors
D019440:Anti-Obesity Agents; D001067:Appetite Depressants; D003503:Cyclobutanes; D007783:Lactones; D000077403:Orlistat; C058254:sibutramine