This is a double-blind, placebo-controlled study of the efficacy, safety, and tolerability of sibutramine in the management of obese patients for a 6-month period.METHOD: Sixty-one obese patients (BMI >30, <40 kg/m2), aged 18-65 years were evaluated. In the first phase of the study (30 days), the patients were given a placebo. We monitored compliance with a low-calorie diet (1200 kcal/day) and to the placebo. In the next stage, the double-blind phase (6 months), we compared placebo and sibutramine (10 mg/day). The criteria for evaluating efficacy were weight loss, reduction in body mass index (BMI), and abdominal and hip circumferences. Tolerability was assessed based on reported side effects, variation in arterial blood pressure and heart rate, metabolic profile (fasting glucose, total cholesterol and its fractions, and triglycerides), laboratory tests (renal and hepatic functions), and flow Doppler echocardiogram. RESULTS:We observed a greater weight loss (7.3 kg, 8% vs 2.6 kg, 2.8%) and a reduction in body mass index (7.4% vs 2.1%) in the sibutramine group than in the placebo group. Classifying the patients into 4 subgroups according to weight loss (weight gain, loss <5%, loss of 5% to 9.9%, and loss >10%), we observed a weight loss of >5% in 40% of the patients on sibutramine compared with 12.9% in the placebo group. We also detected weight gain in 45.2% of the placebo group compared to 20% in the sibutramine group. The sibutramine group showed improvement in HDL-cholesterol values (increased by 17%) and triglyceride values (decreased by 12.8%). This group also showed an increase in systolic blood pressure (6.7%, 5 mmHg). There were no changes in echocardiograms comparing the beginning and end of follow-up, and side effects did not lead to discontinuation of treatment.DISCUSSION: Sibutramine proved to be effective for weight loss providing an 8% loss of the initial weight. Compliance to prolonged treatment was good, and side effects did not result in discontinuation of treatment. These data confirmed the good efficacy, tolerability, and safety profiles of sibutramine for treatment of obesity. DESCRIPTORS: Obesity. Weight loss. Sibutramine.
(APC, CCL, AH). RESUMOO objetivo deste trabalho foi estudar através da ecodopplercardiografia as funções sistólica e diastólica do coração de indivíduos obesos sadios, não complicados, sem diabetes e normotensos. Para tanto, foram avaliados 60 indivíduos obesos com índice de massa corpórea (IMC) médio de 35kg/m 2 e comparados a grupo controle de 39 indiví-duos hígidos com IMC médio de 24kg/m 2 . Os resultados permitiram concluir que no grupo de indivíduos obesos sadios, não complicados e assintomáticos foi encontrada nítida tendência a valores mais elevados da pressão arterial sistólica, um aumento da hipertrofia e consequentemente da massa miocárdica, uma elevação do estresse circunferencial da parede ventricular esquerda e indiscutível presença de uma disfunção diastólica já instalada. Diante desses achados, os autores postulam a necessidade imperativa da realização de uma avaliação semiológica mais profunda e específica nos pacientes com real excesso de peso. ) of 39 subjects. Our results show that obese group was associated with an increased systolic blood pressure, increased left ventricular mass and augmented systolic circumferencial wall stress. Filling abnormalities were observed with impairment of relaxation prolonged isovolumic relaxation time (IVRT) and augmented atrial contribution represent an early index of cardiac dysfunction when systolic performance is still normal. Obesity is generally a chronic condition and echocardiography as a noninvasive method can be used for repeated assessment of cardiac performance.
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