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1.
Ann Intern Med ; 145(2): 81-90, 2006 Jul 18.
Artigo em Inglês | MEDLINE | ID: mdl-16847290

RESUMO

BACKGROUND: Increased prevalence of adolescent obesity requires effective treatment options beyond behavior therapy. OBJECTIVE: To see whether sibutramine reduced weight more than placebo in obese adolescents who were receiving a behavior therapy program. DESIGN: 12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002. SETTING: 33 U.S. outpatient clinics. PARTICIPANTS: 498 participants 12 to 16 years of age with a body mass index (BMI) that was at least 2 units more than the U.S. weighted mean of the 95th percentile based on age and sex, to the upper limit of 44 kg/m2. INTERVENTIONS: Site-specific behavior therapy plus 10 mg of sibutramine or placebo. Blinded study medication dose was uptitrated to 15 mg or placebo at month 6 if initial BMI was not reduced by 10%. MEASUREMENTS: Body mass index, waist circumference, body weight, fasting lipid and glycemic variables, safety, and tolerability. RESULTS: Seventy-six percent of patients in the sibutramine group and 62% of patients in the placebo group completed the study. The estimated mean treatment group difference at month 12 (linear mixed-effects model) favored sibutramine for change from baseline in BMI (-2.9 kg/m2 [95% CI, -3.5 to -2.2 kg/m2]) and body weight (-8.4 kg [CI, -9.7 to -7.2 kg]) (P < 0.001 for both). The sibutramine group had greater improvements in triglyceride levels, high-density lipoprotein cholesterol levels, insulin levels, and insulin sensitivity (P < or = 0.001 for all). The rate of tachycardia was greater with sibutramine vs. placebo (12.5% vs. 6.2%; difference, 6.3 percentage points [CI, 1.0 to 11.7 percentage points]) but did not lead to increased withdrawal (2.4% vs. 1.5%; difference, 0.9 percentage point [CI, -1.7 to 3.5 percentage points]). LIMITATIONS: The 1-year study duration precluded assessment of long-term weight maintenance and putative health benefits and harms, and 24% and 38% of the sibutramine and placebo groups, respectively, did not complete follow-up. CONCLUSIONS: Sibutramine added to a behavior therapy program reduced BMI and body weight more than placebo and improved the profile of several metabolic risk factors in obese adolescents.


Assuntos
Depressores do Apetite/uso terapêutico , Ciclobutanos/uso terapêutico , Obesidade/tratamento farmacológico , Adolescente , Depressores do Apetite/efeitos adversos , Terapia Comportamental , Pressão Sanguínea , Estatura , Índice de Massa Corporal , Criança , Terapia Combinada , Ciclobutanos/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Obesidade/sangue , Obesidade/fisiopatologia , Pulso Arterial , Maturidade Sexual , Taquicardia/induzido quimicamente , Redução de Peso
2.
AAPS J ; 7(1): E42-6, 2005 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-16146348

RESUMO

Levothyroxine sodium is a drug with a narrow therapeutic index for which an individual patient must have his or her dose carefully titrated to achieve the necessary therapeutic effect. In addition, exogenous levothyroxine cannot be distinguished from the endogenously produced hormone. Since 2004, generic formulations have been approved for the most frequently prescribed brands of levothyroxine sodium. This review examines the methodology and statistical acceptance criteria and summarizes findings of a previously published relative bioavailability study that brings into question the use of standard criteria to assess bioequivalence of levothyroxine sodium. The key findings reviewed were the following: (1) in the absence of baseline correction for endogenous T4 levels, products that differed by as much as 25% to 33% would be declared bioequivalent; (2) the use of baseline correction reduced the likelihood of declaring products bioequivalent when they actually differed by 25% to 33%; (3) even with baseline correction, products that differed by 12.5% would be declared bioequivalent; and (4) there was evidence of significant carryover from one dosing period to the next even with washout periods of up to 53 days. In conclusion, the current recommended methodology in the United States to assess bioequivalence for levothyroxine sodium products is inadequate to differentiate products that differ by 12.5%, a clinically relevant difference. Recommendations are made for modifications to the criteria that could improve the likelihood that products that differ by a clinically significant amount in their bioavailability would not be accepted as bioequivalent.


Assuntos
Biofarmácia/métodos , Tiroxina/farmacocinética , Adolescente , Adulto , Fatores Etários , Idoso , Área Sob a Curva , Disponibilidade Biológica , Biofarmácia/normas , Química Farmacêutica , Criança , Pré-Escolar , Comorbidade , Estudos Cross-Over , Relação Dose-Resposta a Droga , Medicamentos Genéricos/administração & dosagem , Medicamentos Genéricos/farmacocinética , Medicamentos Genéricos/normas , Feminino , Guias como Assunto , Humanos , Hipotireoidismo/sangue , Hipotireoidismo/tratamento farmacológico , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Gravidez , Complicações na Gravidez/tratamento farmacológico , Equivalência Terapêutica , Glândula Tireoide/efeitos dos fármacos , Glândula Tireoide/metabolismo , Tireotropina/sangue , Tiroxina/administração & dosagem , Tiroxina/sangue , Tiroxina/normas , Estados Unidos , United States Food and Drug Administration/normas
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