Controversy about the cardiovascular safety of sibutramine

Drug Safety

Volumn 33, Issue 7, 2010, Pages 615-618

  Scheen, André J ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

Adverse reactions; Antihyperglycaemics; Cardiovascular disorders; Drug induced; Obesity therapies; Postmarketing surveillance; Rosiglitazone; Sibutramine

Indexed keywords

DEXFENFLURAMINE; PLACEBO; ROSIGLITAZONE; SIBUTRAMINE; ANOREXIGENIC AGENT; CYCLOBUTANE DERIVATIVE;

BODY MASS; BODY WEIGHT; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CLINICAL TRIAL; CONTINUOUS INFUSION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; GENERAL PRACTITIONER; HEART INFARCTION; HEART PALPITATION; HIGH RISK PATIENT; HUMAN; HYPERTENSION; HYPOTENSION; ISCHEMIC HEART DISEASE; MITRAL VALVE DISEASE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NOTE; OBESITY; POPULATION; PRESCRIPTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PULMONARY HYPERTENSION; SIDE EFFECT; SWEATING; TACHYCARDIA; TREATMENT CONTRAINDICATION; TREATMENT DURATION; UNITED KINGDOM; VOMITING; CARDIOVASCULAR DISEASES; CHEMICALLY INDUCED; COMPLICATION; RISK;

APPETITE DEPRESSANTS; CARDIOVASCULAR DISEASES; CYCLOBUTANES; HUMANS; OBESITY; RISK;

EID: 77953587799     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11538810-000000000-00000     Document Type: Note

References (22)

1. Poirier P, Giles TD, Bray GA, et al. Obesity and cardio-vascular disease: pathophysiology, evaluation, and effect of weight loss: an update of the 1997 American Heart Association Scientific Statement on Obesity and Heart Disease from the Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation 2006; 113: 898-918
2. Zalesin KC, Franklin BA, Miller WM, et al. Impact of obesity on cardiovascular disease. Endocrinol Metab Clin North Am 2008; 37: 663-684
3. Greenway FL, Caruso MK. Safety of obesity drugs. Expert Opin Drug Saf 2005; 4: 1083-1095
4. Robinson JR, Niswender KD. What are the risks and the benefits of current and emerging weight-loss medications? Curr Diab Rep 2009; 9: 368-375
5. Kaul S, Bolger AF, Herrington D, et al. Thiazolidinedione drugs and cardiovascular risks: a science advisory from the American Heart Association and American College of Cardiology Foundation. Circulation 2010; 121: 1868-1877
6. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457-2471
7. Sharma B, Henderson DC. Sibutramine: current status as an anti-obesity drug and its future perspectives. Expert Opin Pharmacother 2008; 9: 2161-2173
8. Tziomalos K, Krassas GE, Tzotzas T. The use of sibu-tramine in the management of obesity and related disorders: an update. Vasc Health Risk Manag 2009; 5: 441-452
9. Nisoli E, Carruba MO. A benefit-risk assessment of sibutramine in the management of obesity. Drug Saf 2003; 26: 1027-1048
10. de Simone G, D'Addeo G. Sibutramine: balancing weight loss benefit and possible cardiovascular risk. Nutr Metab Cardiovasc Dis 2008; 18: 337-341
11. James WPT. The SCOUT study: risk-benefit profile of si-butramine in overweight high-risk cardiovascular patients. Eur Heart J 2005; 7 Suppl. L: L44-8
12. Caterson I, Coutinho W, Finer N, et al., for The SCOUT Investigators. Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period. Obesity 2010; 18: 987-994
13. Finer N, Executive Steering Committee of the Sibutramine Cardiovascular Outcome Trial. Withdrawal of sibu-tramine: editorial is judgment in advance of the facts. BMJ 2010 Mar 10; 340: c1346
14. Harrison-Woolrych M, Ashton J, Herbison P. Fatal and non-fatal cardiovascular events in a general population prescribed sibutramine: a prospective cohort study. Drug Safety 2010; 33 (7): 605-613
15. Perrio MJ, Wilton LV, Shakir SA. The safety profiles of orlistat and sibutramine: results of prescription-event monitoring studies in England. Obesity 2007; 15: 2712-2722
16. Calle EE, Thun MJ, Petrelli JM, et al. Body mass index and mortality in a prospective cohort study of US adults. N Engl J Med 1999; 341: 1097-1105
17. Ford ES, Ajani UA, Croft JB, et al. Explaining the decrease in US deaths from coronary disease, 1980-2000. N Engl J Med 2007; 356: 2388-2398
18. Gregg EW, Cheng YJ, Cadwell BL, et al. Secular trends in cardiovascular disease risk factors according to body mass index in US adults. JAMA 2005; 293: 1868-1874
19. Rosengren A, Eriksson H, Hansson PO, et al. Obesity and trends in cardiovascular risk factors over 40 years in Swedish men aged 50. J Intern Med 2009; 266: 268-276
20. Rosengren A. Declining cardiovascular mortality and in-creasing obesity: a paradox. CMAJ 2009; 181: 127-128
21. O'Flaherty M, Ford E, Allender S, et al. Coronary heart disease trends in England and Wales from 1984 to 2004: concealed levelling of mortality rates among young adults. Heart 2007; 94: 178-181
22. Goldfine AB. Assessing the cardiovascular safety of diabetes therapies. N Engl J Med 2008; 359: 1092-1095