RESUMO
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 percent vs 2.6 kg, 2.8 percent) and a reduction in body mass index (7.4 percent vs 2.1 percent) in the sibutramine group than in the placebo group. Classifying the patients into 4 subgroups according to weight loss (weight gain, loss <5 percent, loss of 5 percent to 9.9 percent, and loss >10 percent), we observed a weight loss of >5 percent in 40 percent of the patients on sibutramine compared with 12.9 percent in the placebo group. We also detected weight gain in 45.2 percent of the placebo group compared to 20 percent in the sibutramine group. The sibutramine group showed improvement in HDL- cholesterol values (increased by 17 percent) and triglyceride values (decreased by 12.8 percent). This group also showed an increase in systolic blood pressure (6.7 percent, 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 percent 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