Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

Abstract

This study aims to determine the efficacy and tolerability of sibutramine hydrochloride in overweight and obese patients with cardiovascular risk factors. This was a 12-week, open-label, observational trial carried out in primary care settings. Patients' data were obtained from questionnaires received from 153 physicians. A total of 2225 overweight and obese (BMIX27 kg/m 2 ) patients received sibutramine in single daily doses of 10 and/or 15 mg. The study population included patients in general good health and with controlled hypertension (41.2%), type II diabetes mellitus (15.6%), hyperlipidaemia (45.5%), and who were chronic tobacco users (smokers) (37.0%). The main outcome measures were changes in body weight, blood pressure and heart rate, and evaluation of reported adverse events. Reduction of body weight of at least 45% from baseline to week 12 was achieved in 2030 (91%) patients and 410% was achieved in 987 (44%) patients. Baseline differences in the percentages of male and female patients, presence or absence of hyperlipidaemia or smoking status did not appear to affect the rate of weight change. Weight loss was less in patients with type II diabetes mellitus and/or controlled systolic hypertension at baseline compared to those patients without these conditions. Mean systolic and diastolic blood pressure and heart rate decreased from baseline to week 12. Overall, sibutramine was well tolerated. In conclusions, treatment with sibutramine resulted in clinically significant weight loss during short-term therapy in obese adults with a range of cardiovascular risk factors.

Association of CYP2B6, CYP3A5, and CYP2C19 Genetic Polymorphisms With Sibutramine Pharmacokinetics in Healthy Korean Subjects

“…The associate director of the US Food and Drug Administration's Office of Drug Safety has indicated that sibutramine is one of five drugs currently on the market that may be endangering patients 41 . It was also reported that sibutramine is associated with QT prolongation and adverse cardiovascular effects, such as tachycardia, hypertension, and arrhythmia 40 , 42 , 43 . Recently it was revealed that sibutramine itself blocks hERG channels in a concentration‐, voltage‐, state‐, and time‐dependent manner 44 .…”

Cardiovascular Risk-Benefit Profile of Sibutramine

“…The efficacy and tolerability of sibutramine (10-15 mg/day) in 2,225 overweight or obese patients with CVD risk factors were examined in a 12-week, open-label, observational trial carried out in primary care settings in Poland. [84] The study population included patients in general good health and with controlled hypertension (41%), T2DM (15%), hyperlipidaemia (45%), and who were chronic tobacco users (smokers) (37%). Mean systolic and diastolic BP and HR decreased from baseline to week 12.…”

Sibutramine: current status as an anti-obesity drug and its future perspectives

“…In 3 months, 91% and 41% of subjects lost ≥ 5% and ≥ 10% weight from baseline, which was independent of the presence or absence of dyslipidemia. However, DM and hypertensive patients lost less weight comparatively, although BP and HR were decreased in all patients [76] . Meanwhile, sibutramine, when compared with placebo in a primary care setting followed for 54 weeks, showed more weight loss, which correlated with improvement in serum triglycerides and HDL-C levels.…”