Details

Autor(en) / Beteiligte

• Hiatt, William R
• Kaul, Sanjay
• Smith, Robert J

Titel

The Cardiovascular Safety of Diabetes Drugs — Insights from the Rosiglitazone Experience

Ist Teil von

• The New England journal of medicine, 2013-10, Vol.369 (14), p.1285-1287

Ort / Verlag

United States: Massachusetts Medical Society

Erscheinungsjahr

2013

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• A signal of cardiovascular harm with rosiglitazone led to a new FDA policy on diabetes-drug approval. As that signal has faded in recent analyses, should FDA policy change? The management of type 2 diabetes has been challenged by uncertainty about possible cardiovascular effects related to treatment intensity and choice of drug. Although the Food and Drug Administration (FDA) considers a decrease in glycated hemoglobin an approvable end point, very intensive glycemic control is associated with increased cardiovascular and all-cause mortality. 1 The safety of specific drugs for type 2 diabetes — particularly the thiazolidinediones — has also been questioned. After rosiglitazone had been approved in the United States in 1999 and in Europe in 2000, a highly publicized meta-analysis in 2007 reported a 43% increase in myocardial infarction (P=0.03) . . .