Table 3.
Summary of studies about orlistat, metformin, and sibutramine in children and adolescents.
| Authors and year | Drug | Population treated | Age (years) | Duration | Effects on BMI or other metabolic effects | Adverse events |
|---|---|---|---|---|---|---|
| Chanoine et al. 2005 [8] | Orlistat | 357 obese adolescent | 12–16 | 1 year | BMI: −0.55 SD | Mild to moderate gastrointestinal tract adverse events (9%–50%) |
| Srinivasan et al. 2006 [9] | Metformin | 28 | 9–18 | 6 months | BMI: −1.26 Kg/m2 (P = .002); waist circumference: −2.8 cm (P = .003); fasting insulin: −2.2 mU/liter (P = .011) | Nausea |
| Kay et al. 2001 [10] | Metformin | 24 | 15.6 ± 0.4 | 8 weeks | Body fat: −6.0 ± 0.62; fat-free mass was similar in metformin group and placebo. Enhances insulin sensitivity, significant reduction in plasma leptin, cholesterol, triglycerides, and free fatty acid. | Nausea, dizziness, and stools |
| Freemark and Bursey 2001 [11] | Metformin | 29 | 12–19 | 6 months | BMI: decline of 0.12 SD and a 5.5% reduction in serum leptin in girls. Metformin caused a progressive decline in fasting blood glucose and a reduction in fasting insulin levels. | Transient abdominal discomfort or diarrhea |
| Jones et al. 2002 [12] | Metformin | 82 | 10–16 | 16 weeks | Improved glycemic control, the adjusted mean change from baseline in fasting plasma glucose was −2.4 mmol/L. Mean HbA1c values was significantly lower. | Gastrointestinal side effects (diarrhea) |
| Berkowitz et al. 2003 [13] | Sibutramine | 82 | 13–17 | 6 months | BMI: −8.5% | Elevated blood pressure and/or pulse rate, ventricular premature beats, cholelithiasis, ecchymoses, and rash |
| Berkowitz et al. 2006 [14] | Sibutramine | 498 | 12–16 | 12 months | BMI: −2.9 Kg/m2; body weight: −8.4 Kg (P < .001 for both); greater improvements in triglyceride levels, high-density lipoprotein cholesterol levels, insulin levels and sensitivity | Tachycardia |
| Garcia-Morales et al. 2006 [15] | Sibutramine | 46 | 14–18 | 6 months | BMI: −9.2% | No significant difference in blood pressure, tachycardia, headache with nausea, or weakness |
| Godoy-Matos et al. 2005 [16] | Sibutramine | 60 | 14–17 | 6 months | The mean BMI reduction was greater in the sibutramine group: 3.6 ± 2.5 Kg/m2 | No significant difference in blood pressure or heart rate |
| Van Mil et al. 2007 [17] | Sibutramine | 24 | 12–17 | 12 weeks | Effect on BMI-SDS not significant | Abdominal complaints, insomnia, headache, loss of interest, and loss of appetite |
| Daniels et al. 2007 [18] | Sibutramine | 498 | 12–16 | 12 months | BMI reduction was > or = 5% | Small mean decreases in blood pressure and pulse rate were seen in both sibutramine and placebo |