Comparative estimation of efficiency of orlistat and metformin in patients with type 2 diabetes mellitus and obesity

The study was made to compare the effects of treatment with orlistat on metformin for 6 months on anthropometric parameters, carbohydrate and lipid metabolism, blood pressure, insulin resistance and insulin secretion in patients with type 2 diabetes mellitus. Open study with parallel groups included a total of 60 patients with type 2 diabetes mellitus, aged 40 to 75 years. Before the study all the patients were or diet alone, or not more than 1 tablet of medication of sulphonylurea, their fasting plasma glucose was < 12 mmol/l, they had hypercholesterinemia and or hypertriglyceridemia. Each individual was assigned randomly to receive 120 mg orlistat three times daily or metformin, in the initial dosage 500 mg, and successive increment of the dosage to the therapeutic level. Both groups received the same dietary counseling. Initially and 1, 2, 3 and 6 months later body mass, body mass index, blood pressure, the levels of fasting blood glucose levels, Нb А_1с, triglycerides, cholesterin, low- density lipoprotein (LDL), high-density lipoproteis (HDL) were determined. Initially and after treatment an oral glucose tolerance test was performed with estimation of glycemia and insulin levels with calculation of index of insulin resistance assessed by the homeostasis model for assessment of insulin resistance (HOMA). From orlistat group 2 patients and from metformin group 5patients were withdrawn, but in no case because of side-effects. In the orlistat group there was more pronounced positive dynamics in trend of anthropometric parameters alteration than in the metformin group. The orlistat group lost 8,4 ± 3,7% of initial body mass vs. 4.5 ± 2.7% in the metformin group (P < 0.001), decline of body mass index was 3,3 ± 1,8 and 1,6 ± 0,9 kg/m² (p < 0,001), decrement of waist circumference was -8,9 ± 4,6 and 5,2 ± 3,8 cm respectively (p < 0,003). Both therapeutic groups showed significantly reduced systolic and diastolic blood pressure values, fasting blood glucose levels, total cholesterd, low-density lipoprotein (LDL) cholesterol, triglycerides levels in patient with initial hypertriglyceridaemia without any difference between the two groups. Initial Нb А_1с levels in orlistat and metformin groups reached 9,2 ± 1,5% and 9,1 ± 2,0%, treatment with orlistat was followed by significant statistical and clinically significant decrease of Нb А_1с levels to 8,0 ± 1,5% (p < 0,001), in the metformin group it did not change significantly (8,7 ± 1,7%, p > 0,05). The part of the patients with Нb А_1с in the metformin group before and after treatment was equal 20% and 23,3% respectively, in the orlistat group, respectively, 16,5% and 30%, although the tendency in both groups did not reach statistical significance. The glycemia level during GTT reduced significantly in both groups, IRI levels did not change. In the metformin group there was significant improvement in sensitivity to insulin (IR-HOMA decreased from 6,1 ± 4,6 to 4,2 ± 2,6 (p = 0,024). In the orlistat group mean IRI-HOMA did not change, but there was significant increase in the part of patients with normal sensitivity to insulin (from 10% to 33,3%, p - 0,035), that was not seen in the metformin group. Orlistat is not inferior to metformin in the ability for reducing plasma glucose level and as remedy for correction of dislipidemia and may be used as medication of choice in patients with type 2 diabetes mellitus with excessive body weight and obesity.

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