Endocrine Abstracts

Background: Metabolic syndrome (MS) in children is associated with future risk of developing type 2 diabetes mellitus and cardiovascular disease in adults. In the pediatric population lifestyle interventions alone are often insufficient.

Objective: To evaluate the efficacy and safety of orlistat in obese adolescents with MS.

Design: A 6 month open, comparative, randomized study of 60 obese adolescents (aged 12–17 years; mean body mass index (BMI) 32 kg/m²) with MS. The main group (n=30) was treated with a hypocaloric diet, aerobic exercises and orlistat 120 mg three times daily for 6 months. The control group (n=30) was subjected to the same diet and exercise regimen without the orlistat application. Changes in BMI, waist circumference, body composition, blood pressure, fasting serum lipid and glycemic parameters were evaluated.

Results: BMI decreased by 3.09 kg/m² in the orlistat group and only by 1.11 kg/m² in the control group (P=0,033). The orlistat group compared with the control group also had a significant reduction of body fat (−6600,0 vs −2235,5 g, P=0.011), waist circumference (−6.50 vs −2.50 cm, P=0.019), LDL-cholesterol (−0.33 vs −0.20 mmol/l, P=0.024) and total cholesterol levels (−0.25 vs −0.05 mmol/l, P=0.025). HDL-cholesterol, triglyceride levels and blood pressures improved similarly within both groups; comparisons between groups, however, were not statistically significant. After 6 months of orlistat therapy 68% of the adolescents achieved clinically meaningful weight loss. In the control group only 41% of patients reduced their weight by more than 5%. Orlistat was well tolerated by patients. Most adverse events were mild and can be attributed to the expected adverse reactions.

Conclusion: The study demonstrated significant efficacy and safety when orlistat was combined with the complex therapy in obese adolescents with MS.

Declaration of interest: The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project.

Funding: This research did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector.