Skip to main content
Erschienen in: Diabetologia 2/2011

01.02.2011 | Commentary

Rosiglitazone: a European regulatory perspective

verfasst von: E. Blind, K. Dunder, P. A. de Graeff, E. Abadie

Erschienen in: Diabetologia | Ausgabe 2/2011

Einloggen, um Zugang zu erhalten

Excerpt

Rosiglitazone, a drug for the treatment of type 2 diabetes, which has been authorised for use in the EU since 11 July 2000, has attracted continuous scrutiny with regard to its cardiovascular safety profile. The European Medicines Agency (EMA)’s scientific committee, the Committee for Medicinal Products for Human Use (CHMP), in its most recent comprehensive review of rosiglitazone (started 8 July 2010 and completed 22 September 2010), concluded that the benefits of rosiglitazone no longer outweigh the risks, and that the marketing authorisation of the drug in the EU should be suspended [1]. …
Literatur
4.
Zurück zum Zitat Nissen SE, Wolski K (2007) Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356:2457–2471CrossRefPubMed Nissen SE, Wolski K (2007) Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356:2457–2471CrossRefPubMed
5.
Zurück zum Zitat Drazen JM, Morrissey S, Curfman GD (2007) Rosiglitazone—continued uncertainty about safety. N Engl J Med 357:63–64CrossRefPubMed Drazen JM, Morrissey S, Curfman GD (2007) Rosiglitazone—continued uncertainty about safety. N Engl J Med 357:63–64CrossRefPubMed
6.
Zurück zum Zitat Montori VM, Gandhi GY, Guyatt GH (2007) Patient-important outcomes in diabetes—time for consensus. Lancet 370:1104–1106CrossRefPubMed Montori VM, Gandhi GY, Guyatt GH (2007) Patient-important outcomes in diabetes—time for consensus. Lancet 370:1104–1106CrossRefPubMed
7.
Zurück zum Zitat Nathan DM (2007) Rosiglitazone and cardiotoxicity—weighing the evidence. N Engl J Med 357:64–66CrossRefPubMed Nathan DM (2007) Rosiglitazone and cardiotoxicity—weighing the evidence. N Engl J Med 357:64–66CrossRefPubMed
8.
Zurück zum Zitat Psaty BM, Furberg CD (2007) The record on rosiglitazone and the risk of myocardial infarction. N Engl J Med 357:67–69CrossRefPubMed Psaty BM, Furberg CD (2007) The record on rosiglitazone and the risk of myocardial infarction. N Engl J Med 357:67–69CrossRefPubMed
9.
Zurück zum Zitat Psaty BM, Furberg CD (2007) Rosiglitazone and cardiovascular risk. N Engl J Med 356:2522–2524CrossRefPubMed Psaty BM, Furberg CD (2007) Rosiglitazone and cardiovascular risk. N Engl J Med 356:2522–2524CrossRefPubMed
10.
Zurück zum Zitat Rosen CJ (2007) The rosiglitazone story—lessons from an FDA Advisory Committee meeting. N Engl J Med 357:844–846CrossRefPubMed Rosen CJ (2007) The rosiglitazone story—lessons from an FDA Advisory Committee meeting. N Engl J Med 357:844–846CrossRefPubMed
11.
Zurück zum Zitat Home PD, Jones NP, Pocock SJ et al (2007) Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med 24:626–634CrossRefPubMed Home PD, Jones NP, Pocock SJ et al (2007) Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med 24:626–634CrossRefPubMed
12.
Zurück zum Zitat Home PD, Pocock SJ, Beck-Nielsen H et al (2009) Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 373:2125–2135CrossRefPubMed Home PD, Pocock SJ, Beck-Nielsen H et al (2009) Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 373:2125–2135CrossRefPubMed
13.
Zurück zum Zitat Dormandy JA, Charbonnel B, Eckland DJ et al (2005) Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 366:1279–1289CrossRefPubMed Dormandy JA, Charbonnel B, Eckland DJ et al (2005) Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 366:1279–1289CrossRefPubMed
14.
Zurück zum Zitat Nathan DM, Buse JB, Davidson MB et al (2009) Medical management of hyperglycaemia in type 2 diabetes mellitus: 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 52:17–30CrossRefPubMed Nathan DM, Buse JB, Davidson MB et al (2009) Medical management of hyperglycaemia in type 2 diabetes mellitus: 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 52:17–30CrossRefPubMed
15.
Zurück zum Zitat Graham DJ, Ouellet-Hellstrom R, MaCurdy TE et al (2010) Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 304:411–418CrossRefPubMed Graham DJ, Ouellet-Hellstrom R, MaCurdy TE et al (2010) Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 304:411–418CrossRefPubMed
16.
Zurück zum Zitat Nissen SE, Wolski K (2010) Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 170:1191–1201CrossRef Nissen SE, Wolski K (2010) Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 170:1191–1201CrossRef
18.
Zurück zum Zitat Wertz DA, Chang CL, Sarawate CA, Willey VJ, Cziraky MJ, Bohn RL (2010) Risk of cardiovascular events and all-cause mortality in patients treated with thiazolidinediones in a managed-care population. Circ Cardiovasc Qual Outcomes 3:538–545CrossRefPubMed Wertz DA, Chang CL, Sarawate CA, Willey VJ, Cziraky MJ, Bohn RL (2010) Risk of cardiovascular events and all-cause mortality in patients treated with thiazolidinediones in a managed-care population. Circ Cardiovasc Qual Outcomes 3:538–545CrossRefPubMed
21.
24.
Zurück zum Zitat UK Prospective Diabetes Study (UKPDS) Group (1998) Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352:837–853CrossRef UK Prospective Diabetes Study (UKPDS) Group (1998) Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352:837–853CrossRef
Metadaten
Titel
Rosiglitazone: a European regulatory perspective
verfasst von
E. Blind
K. Dunder
P. A. de Graeff
E. Abadie
Publikationsdatum
01.02.2011
Verlag
Springer-Verlag
Erschienen in
Diabetologia / Ausgabe 2/2011
Print ISSN: 0012-186X
Elektronische ISSN: 1432-0428
DOI
https://doi.org/10.1007/s00125-010-1992-5

Weitere Artikel der Ausgabe 2/2011

Diabetologia 2/2011 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.