Suspension of the commercialization of sibutramine and rosiglitazone in Europe;Suspension de la commercialisation de la sibutramine et de la rosiglitazone en Europe

Revue Medicale de Liege

Volumn 65, Issue 10, 2010, Pages 574-579

  Scheen, A J ^a,b  

^a UNIVERSITY OF LIÈGE   (Belgium)

^b UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

Cardiovascular safety; Diabetes; Myocardial infarction; Obesity; Rosiglitazone; Sibutramine

Indexed keywords

METFORMIN; METFORMIN PLUS ROSIGLITAZONE; PIOGLITAZONE; PLACEBO; ROSIGLITAZONE; SIBUTRAMINE; SULFANILAMIDE; TETRAHYDROLIPSTATIN;

CLINICAL DECISION MAKING; DRUG MARKETING; EUROPE; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; REVIEW;

APPETITE DEPRESSANTS; CYCLOBUTANES; EUROPE; HUMANS; HYPOGLYCEMIC AGENTS; PRODUCT SURVEILLANCE, POSTMARKETING; SAFETY-BASED DRUG WITHDRAWALS; THIAZOLIDINEDIONES;

EID: 78049471936     PISSN: 00353663     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (41)

1. Van Gaal LF, Mertens IL, De Block CE. - Mechanisms linking obesity with cardiovascular disease. Nature, 2006, 444, 875-880.
2. Ryden L, Standl E, Bartnik M, et al. - Guidelines on diabetes, pre-diabetes, and cardiovascular diseases : executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J, 2007, 28, 88-136.
3. Scheen AJ. - Current management strategies for coexisting diabetes mellitus and obesity. Drugs, 2003, 63, 1165-1184.
4. Klein S, Burke LE, Bray GA, et al. - Clinical implications of obesity with specific focus on cardiovascular disease: a statement for professionals from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: endorsed by the American College of Cardiology Foundation. Circulation, 2004, 110, 2952-2967.
5. Rorive M, De Flines J, Paquot N, et al. - Actualités thérapeutiques dans le domaine de l'obésité. Rev Med Liège, 2007, 62, 329-334.
6. Scheen AJ. - The future of obesity: new drugs versus lifestyle interventions. Expert Opin Investig Drugs, 2008, 17, 263-267.
7. Scheen AJ, Paquot N. - Pharmacological treatment of obesity, food intake, and reversal of metabolic disorders. Curr Nutr Food Sci, 2007, 3, 123-133.
8. Scheen AJ, Lefèbvre PJ. - Pharmacological treatment of obesity: present status. Int J Obes, 1999, 23 (Suppl 1), 47-53.
9. Scheen AJ. - Après la tempête sur les anorexigènes centraux, l'étude «STORM» avec la sibutramine. Rev Med Liège, 2001, 56, 56-58.
10. Curfman GD, Morrissey S, Drazen JM. - Sibutramine - another flawed diet pill. N Engl J Med, 2010, 363, 972-974.
11. Scheen AJ, Lefèbvre PJ. - Le traitement pharmacologique du diabète de type 2 est-il maudit ? Méd Hyg, 1998, 56, 1539-1540.
12. Scheen AJ. - Exenatide once weekly in type 2 diabetes (comment). Lancet, 2008, 372, 1197-1198.
13. Scheen AJ , Van Gaal LF. - Rimonabant (Acomplia®). Premier antagoniste des récepteurs CB1 du système endocannabinoïde. Rev Med Liège, 2008, 63, 50-55.
14. Scheen AJ. - La sibutramine (Reductil®). Rev Med Liège, 2001, 56, 656-659.
15. European Medicines Agency. - European Medicines Agency recommends suspension of marketing autorisation for sibutramine [online]. Available from URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2 [Accessed 2010 Jul 18]
16. Scheen AJ. - La rosiglitazone (Avandia®). Rev Med Liège, 2002, 57, 236-239.
17. European Medicines Agency (EMA). - Suspension of rosiglitazone. www.ema.europa.eu/docs/en-GB/document.../09/WC500096996.pdf
18. Scheen AJ, Ernest Ph. - Antiobesity treatment in type 2 diabetes : results of clinical trials with orlistat and sibutramine. Diabetes Metab, 2002, 28, 437-445.
19. Scheen AJ. - Controversy about the cardiovascular safety of sibutramine. Drug Safety, 2010, 33, 615-618.
20. Scheen AJ. - Sibutramine : a review of its cardiovascular risk-benefit profile. Am J Cardiovasc Drugs, 2010, 10, 321-334.
21. James WP, Caterson ID, Coutinho W, et al; SCOUT Investigators. - Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med, 2010, 363, 905-917.
22. US Food and Drug Administration. - Meridia (sibutramine hydrochloride) : follow-up to an early communication about an ongoing safety review [online]. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm198221.htm [Accessed 2010 Jul 18].
23. Scheen AJ, Paquot N. - Récepteurs PPAR-γ, nouvelle cible thérapeutique dans les pathologies métaboliques et cardio-vasculaires. Rev Med Liège, 2005, 60, 89-95.
24. Scheen AJ, Radermecker RP, Philips JC, et al. - Le traitement du diabète de type 2 : entre insulinosensibilisateurs et insulinosécrétagogues. Rev Med Liège, 2007, 62, (numéro spécial), 40-46.
25. Scheen AJ. - Glitazones et prise de poids. Ann. Endocrinol (Paris), 2002, 63, 1S41-1S44.
26. Scheen AJ, Lefèbvre PJ. - L'étude PROactive : prévention secondaire des accidents cardio-vasculaires par la pioglitazone chez le patient diabétique de type 2. Rev Med Liège, 2005, 60, 896-901.
27. Nesto RW, Bell D, Bonow RO, et al. - Thiazolidinedione use, fluid retention, and congestive heart failure. A consensus statement from the American Heart Association and American Diabetes Association. Diabetes Care, 2004, 27, 256-263.
28. De Flines J, Scheen AJ. - Glitazones et insuffisance cardiaque : les point sur les études PROactive, ADOPT, DREAM et RECORD. Rev Med Suisse, 2007, 3, 1876-1883.
29. 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.
30. Scheen AJ, De Flines J, Paquot N. - Le point sur la controverse à propos de la rosiglitazone. Rev Med Liège, 2007, 62, 560-565.
31. Home PD, Pocock SJ, Beck-Nielsen H, et al. - Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD) : a multicentre, randomised, open-label trial. Lancet, 2009, 373, 2125-2135.
32. Nathan DM, Buse JB, Davidson MB, et al. - Medical management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia, 2009, 52, 17-30.
33. Scheen AJ. - Rosiglitazone : to be or not to be ? Diabetologia, 2009, 52, 1448-1450.
34. Nissen SE, Wolski K. - Rosiglitazone Revisited : an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med, 2010 Jun 28. [Epub ahead of print]
35. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al. - Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA, 2010, 304, 411-418.
36. Scheen AJ. - Comment j'explore ... les critères de jugement dans les essais cliniques : réflexion à propos d'études récentes de prévention cardio-vasculaire. Rev Med Liège, 2006, 61, 260-266.
37. Scheen AJ. - Hepatotoxicity with thiazolidinediones. Drug Safety, 2001, 24, 873-888.
38. Scheen AJ. - Combined thiazolidinedione-insulin therapy. Should we be concerned about safety ? Drug Safety, 2004, 27, 841-856.
39. Graham DJ, Gelperin K. - FDA on rosiglitazone. More on advisory committee decision. BMJ, 2010 Sep 7;341:c4868. doi : 10.1136/bmj.c4868.
40. Woodcock J, Sharfstein JM, Hamburg M. - Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med, 2010 [Epub ahead of print] 10.1056/nejmp1010788 nejm.org.
41. Goldfine AB. - Assessing the cardiovascular safety of diabetes therapies. N Engl J Med, 2008, 359, 1092-1095.