RESUMO
BACKGROUND: The prevalence of overweight and obesity in children and adolescents is increasing in both the United States and Mexico. OBJECTIVE: The goal of this article was to assess the efficacy and safety of sibutramine in obese Mexican adolescents. METHODS: This was a 6-month, randomized, double-blind, placebo-controlled, prospective clinical trial of sibutramine QD. Male and female patients aged 14 to 18 years with sex-specific body mass index (BMI) for age and sex >85th percentile were eligible. The primary end points for the trial were the baseline versus end point absolute values for body weight, BMI, and percentage of the initial BMI (%BMI); secondary end points were waist circumference and percentage of the initial waist circumference (%waist). These were measured at days -15, 0, 30, 60, 90, 120, 150, and 180 of the study. Quality of life was assessed at the study start and end using the 36-Item Short-Form Health Survey (SF-36) questionnaire. Blood pressure and heart rate were assessed, and adverse events (AEs) were recorded. Both groups received individually tailored diet and exercise programs. RESULTS: Forty-six patients (age range, 14-18 years) with a BMI >95th percentile for age were included (sibutramine group, n = 23 [14 females, 9 males]; placebo group, n = 23 [12 females, 11 males]). Twenty-one patients in the sibutramine group and 19 patients in the placebo group completed the 6-month trial. Using the intent-to-treat data, weight (mean [SD]) in the sibutramine group changed from 92.5 (14.6) kg to 85.7 (14.4) kg, for a net weight loss of 7.3 kg (95% CI 4.6-9.9), a waist circumference loss of 8.0 cm (95% CI, 4.7-11.3), and a % BMI loss of 9.2% (95% CI, 6.9-11.6). In the placebo group, weight changed from 98.9 (22.7) kg to 94.6 (22.5) kg, a weight loss of 4.3 kg (95% CI, 1.7-6.9), a waist circumference loss of 3.8 cm (95% CI, 0.7-7.0), and a %BMI loss of 5.2% (95% CI, 2.4-7.9) (P < 0.05 for all intragroup comparisons; P > 0.05 for the intergroup comparisons). Mean (SD) scores on the SF-36 scale in the sibutramine group changed from 78.0 (13.3) at baseline to 84.8 (7.4) at study end (P < 0.05); the respective values in the placebo group were 82.8 (10.3) and 87.3 (7.6) (P < 0.05). At base-line, systolic blood pressure (SBP) was 116.7 (5.9) mm Hg in the sibutramine group and 118.3 (7.6) mm Hg in the placebo group; at end point, the respective SBPs were 112.4 (9.6) mm Hg and 112.6 (6.5) mm Hg. At baseline, diastolic blood pressure (DBP) was 78.9 (4.5) mm Hg in the sibutramine group and 79.5 (5.2) mm Hg in the placebo group; at end point, the respective DBPs were 73.5 (6.3) mm Hg and 76.6 (6.2) mm Hg. At baseline, heart rate was 76.3 (6.4) beats/min in the sibutramine group and 81.1 (9.5) beats/min in the placebo group; at end point, the respective findings were 79.8 (8.8) beats/min and 77.6 (8.6) beats/min (P > 0.05 for all preceding intergroup comparisons). One patient in the sibutramine group had increased blood pressure (at month 3) and 3 had increased heart rate (at months 1, 2, and 4); 2 patients receiving placebo had increased blood pressure (month 3) and 2 had increased heart rate (at months 1 and 3). These changes disappeared in 1 week and did not require treatment or trial suspension. Additionally, in the sibutramine group, 3 patients experienced 4 mild AEs: headache, dry mouth, headache with nausea, and headache with weakness and paleness (P > 0.05). In the placebo group, 3 patients experienced 4 mild AEs: 2 cases of headache, as well as 1 case of headache with somnolence and 1 case of headache with dry mouth (P > 0.05). CONCLUSION: Sibutramine 10 mg QD in addition to diet and exercise was effective and generally well tolerated in this population of obese Mexican adolescents.
Assuntos
Depressores do Apetite/uso terapêutico , Ciclobutanos/uso terapêutico , Obesidade/tratamento farmacológico , Redução de Peso/efeitos dos fármacos , Adolescente , Método Duplo-Cego , Feminino , Humanos , Masculino , México , Estudos Prospectivos , Fatores de TempoRESUMO
Introducción. En los pacientes con deficiencia de hormona de crecimiento (HC), se ha utilizado como estándar de oro el valor máximo obtenido de HC durante una curva de doble estímulo. El objetivo de este estudio fue determinar la correlación existente entre el factor de crecimiento similar a la insulina (IGF-1) y los diversos criterios auxológicos y bioquímicos que determinan el diagnóstico de deficiencia de HC. Material y métodos. Se revisaron los expedientes clínicos de 57 pacientes que presentaban talla baja en los que había sospecha de deficiencia de HC, seguidos por más de 6 meses en su velocidad de crecimiento y a los que se les había practicado curvas de doble estímulo de HC con L-dopa y de hipoglucemia inducida por insulina y que además contaban con determinaciones de IGF-1. Resultados. A 40.3 por ciento de la población se les diagnosticó deficiencia de HC con base a criterios auxológicos y niveles de HC inferiores a 10 ng/mL durante la curva de estímulo, en estos pacientes, la correlación entre niveles máximos de HC e IGF-1 fue de r=0.027. En 19.3 por ciento de la población se descartó deficiencia de HC y la correlación entre IGF-1 y HC fue de r=0.069. Sin embargo al comparar los promedios de IGF-1 entre los pacientes que tenían HC de más de 10 ng/mL y aquellos que tenían menos de 10 ng/mL se encontró diferencia estadísticamente significativa con p menos de 0.001 (128 vs 58.2 ng/mL). Cuando se consideraron niveles de IGF-1 menores a 100 ng/mL la sensibilidad para la detección de déficit de HC fue de 85 por ciento pero la especificidad fue de 50 por ciento. Conclusiones. Se encontró baja correlación entre los valores de IGF-1 y los niveles máximos de HC o área bajo la curva de estimulación. Por otra parte niveles de IGF-1 menores a 100 ng/mL es un parámetro altamente sensible pero moderadamente específico para detectar deficiencia de HC