Evaluation of effectiveness of orlistat in complexed obesity treatment in teenagers with metabolic syndrome

Abstract

An open, comparative, randomized study of orlistat in the combined treatment of obesity in adolescents with metabolic syndrome (IIIb phase) was held. Objective: to evaluate the efficacy and safety of the orlistat in adolescents 12-17 years with high risk of cardiovascular disease and type 2 diabetes. The study included 60 adolescents with obesity and metabolic syndrome. The main group (n=30) followed a hypocaloric diet and aerobic exercises and took orlistat 120 mg 3 times daily with meals, the control (n=30) group was only on the non-drug therapy. During the study the anthropometric parameters, lipid, carbohydrate metabolism, blood pressure were evaluated. All comparisons were performed as two-way, with the critical level of significance ≤ 0,05. Results: After 6 months therapy of orlistat 68% of adolescents achieved clinically meaningful weight loss, that led to the improvement of metabolic parameters. On therapy body fat decreased by -6600.00 g [-7912.00, -2350.00] in the control group, respectively -2235.50 g [-4700, 00; 667.00] (p=0.011). Orlistat was well tolerated by patients. Most adverse events (9 of 13 in the intervention group) were mild and can be attributed to the expected adverse reactions. Conclusion: The study demonstrated clinically significant efficacy (compared with the control group), combined with good safety records of its use in adolescents 12-17 years old with obesity and metabolic disorders.