Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study

Abstract

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.

Development and validation of an analytical method by RP-HPLC for quantification of sibutramine hydrochloride in pharmaceutical capsules

“…2 Sibutramine is a centrally acting drug and its mechanism of action is a selective serotonin and noradrenaline reuptake inhibition.…”

Os efeitos do uso do cloridrato de sibutramina no tratamento da obesidade / Effects of using sibutramine hydrochloride in the treatment of obesity

“…Seu uso em pacientes obesos e hipertensos tem sido questionado, mesmo quando a hipertensão está bem controlada (COUTINHO, 2009). É um fármaco que garante a perda de peso associada à diminuição da circunferência abdominal e redução das taxas lipídicas no sangue (HALPERN et al, 2002). Através de estudos é observado que a perda de peso causada pela sibutramina é moderada, atingindo uma perda de peso de cerca de 5 kg em 12 a 52 semanas (RADAELLI et al, 2016).…”

Rapid Surface Enhanced Raman Scattering (SERS) Detection of Sibutramine Hydrochloride in Pharmaceutical Capsules with a β-Cyclodextrin- Ag/Polyvivnyl Alcohol Hydrogel Substrate

“…Sibutramine hydrochloride (SH) was a commonly used drug for the treatment of obesity. It could play an significant role in the inhibition of serotonin and norepinephrine reuptake, and makes the body produce heat, hence promoting the consumption of fat tissue [ 1 , 2 , 3 , 4 ]. Its good performance in reducing weight made it one of the most adulterated anorexic drugs used in slimming pills [ 5 , 6 ].…”