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

• Published in: Journal of human hypertension Vol. 19; no. 9; pp. 737 - 743
• Main Authors: GACIONG, Z, PLACHA, G
• Format: Journal Article
• Language: English
• Published: Basingstoke Nature Publishing 01-09-2005; Nature Publishing Group
• Subjects: Adult; Antihypertensive agents; Appetite Depressants - administration & dosage; Appetite Depressants - adverse effects; Appetite Depressants - therapeutic use; Arterial hypertension. Arterial hypotension; Biological and medical sciences; Blood and lymphatic vessels; Blood pressure; Blood Pressure - drug effects; Body weight; Body Weight - drug effects; Body weight loss; Cardiology. Vascular system; Cardiovascular diseases; Cardiovascular Diseases - etiology; Cardiovascular system; Clinical manifestations. Epidemiology. Investigative techniques. Etiology; Complications and side effects; Cyclobutanes - administration & dosage; Cyclobutanes - adverse effects; Cyclobutanes - therapeutic use; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - physiopathology; Diagnosis; Diastole; Dosage and administration; Dose-Response Relationship, Drug; Drug therapy; Female; Heart rate; Heart Rate - drug effects; Humans; Hyperlipidemia; Hypertension; Hypertension - complications; Hypertension - physiopathology; Male; Medical sciences; Middle Aged; Obesity - complications; Obesity - drug therapy; Observational studies; Overweight; Overweight - drug effects; Patients; Pharmacology. Drug treatments; Population studies; Primary care; Risk Factors; Sibutramine; Systole; Treatment Outcome; Poland; Endocrinopathy; Short term; Type 2 diabetes; Human; Hypertension; Obesity; Serotonin; type II diabetes mellitus; Nutrition disorder; Metabolic diseases; Cardiovascular disease; Sibutramine; cardiovascular risk factors; Catecholamine; Reuptake inhibitor; Risk factor; Neurotransmitter; Arterial pressure; Norepinephrine; Blood pressure; Anorectic; Nutritional status
• ISSN: 0950-9240; 1476-5527
• DOI: 10.1038/sj.jhh.1001877

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 (BMI> or =27 kg/m2) 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 >5% from baseline to week 12 was achieved in 2030 (91%) patients and >10% 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..