Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects

• Published in: The New England journal of medicine Vol. 363; no. 10; pp. 905 - 917
• Main Authors: James, W. Philip T, Caterson, Ian D, Coutinho, Walmir, Finer, Nick, Van Gaal, Luc F, Maggioni, Aldo P, Torp-Pedersen, Christian, Sharma, Arya M, Shepherd, Gillian M, Rode, Richard A, Renz, Cheryl L
• Format: Journal Article Web Resource
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 02.09.2010
• Subjects: Aged; Appetite Depressants - adverse effects; Appetite Depressants - therapeutic use; Biological and medical sciences; Blood pressure; Blood Pressure - drug effects; Cardiovascular & respiratory systems; Cardiovascular disease; Cardiovascular Diseases - chemically induced; Cardiovascular Diseases - complications; Cardiovascular Diseases - epidemiology; Cardiovascular Diseases - mortality; complications/epidemiology; Cyclobutanes - adverse effects; Cyclobutanes - therapeutic use; Diabetes; Diabetes Mellitus, Type 2 - complications; Double-Blind Method; Endocrinologie, métabolisme & nutrition; Endocrinology, metabolism & nutrition; Female; General aspects; Heart failure; Human health sciences; Humans; Hypertension; Kaplan-Meier Estimate; Male; Medical sciences; Metabolic diseases; Middle Aged; mortality; Myocardial Infarction - chemically induced; Myocardial Infarction - epidemiology; Obesity; Obesity - complications; Obesity - drug therapy; Overweight - complications; Overweight - drug therapy; Pharmacie, pharmacologie & toxicologie; Pharmacy, pharmacology & toxicology; Sciences de la santé humaine; Stroke - chemically induced; Stroke - epidemiology; Systèmes cardiovasculaire & respiratoire; therapeutic use; Human; Obesity; Prognosis; Serotonin; Body weight; Nutrition disorder; Cardiovascular disease; Corporal biometry; Sibutramine; Catecholamine; Reuptake inhibitor; Overweight; Medicine; Neurotransmitter; Norepinephrine; Anorectic; Nutritional status
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1003114

In this clinical trial, the appetite suppressant sibutramine as compared with placebo resulted in modest weight loss but also in an unexpected increase in the risk of nonfatal myocardial infarction and stroke (a finding limited to patients with preexisting cardiovascular disease). Sibutramine should not be used in patients with cardiovascular disease. Obesity and excess weight are escalating public health concerns because they increase the prevalence of associated conditions such as diabetes mellitus and the risk of premature death. 1 , 2 More than 80% of even highly motivated patients are unable to achieve weight loss with dietary and lifestyle modifications alone. 3 Sibutramine is a norepinephrine and serotonin reuptake inhibitor that was approved for weight management in patients who are unable to lose weight by means of diet and exercise alone. Sibutramine induces satiety (resulting in reduced food intake) and an increase in energy expenditure. 4 , 5 In some patients, sibutramine increases blood pressure, pulse . . .