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

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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.

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Copyright (c) 2011 Mel'nichenko G.A., Peterkova V.A., Savel'eva L.V., Zubkova N.A.

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