Comparison of the effects of sibutramine and orlistat on obese, poorly-controlled type 2 diabetic patients.

BACKGROUND We assessed and directly compared weight loss effects of sibutramine and orlistat treatment in a group of obese, poorly-controlled type 2 diabetic patients. METHODS This study recruited 34 diabetic subjects [glycohemoglobin (HbA1c) > 8%] with a body mass index of at least 27 kg/m2. A 36-week, three-phase, prospective, randomized, cross-over comparative study was conducted. In phase 1, 34 patients were randomly divided into two groups. One group received sibutramine for 3 months, then completed a 3 month wash-out period and, finally, shifted to orlistat for another 3 months. The second group followed the same procedure but received orlistat first and then sibutramine. The efficacy measures were rate of weight reduction, glycemic control, insulin sensitivity and cardiovascular risk factors, including waist circumference, lipid profiles and blood pressure. RESULTS The sibutramine-treated group achieved 2.0 kg (2.5%) weight loss with observable but not statistically significant changes in insulin sensitivity, glycemic control, and cardiovascular risk factors. There were no significant changes in systolic or diastolic blood pressure. The weight reduction in the orlistat-treated group was only 0.8 kg (0.9%), which was significantly less than that of the sibutramine group. There were significant differences in total cholesterol, low density lipoprotein cholesterol and HbA1C. Direct comparative analysis revealed no significant differences between these two groups. CONCLUSION This study indicates that sibutramine treatment produced greater reduction in weight than orlistat in obese, poorly-controlled type 2 diabetic patients. However, no significant differences in waist circumference, and lipid or glucose levels were found between the two groups.