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

被引：152

作者：

Hiatt, William R. ^{[1
,2
]}

Kaul, Sanjay ^{[3
,4
]}

Smith, Robert J. ^{[5
,6
]}

机构：

[1] Univ Colorado, Div Cardiol, Sch Med, Aurora, CO USA

[2] Univ Colorado, Colorado Prevent Ctr Clin Res, Dept Med, Sch Med, Aurora, CO USA

[3] Univ Calif Los Angeles, Div Cardiol, Los Angeles, CA USA

[4] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

[5] Brown Univ, Ocean State Res Inst, Alpert Med Sch, Providence, RI 02912 USA

[6] Providence Vet Affairs Med Ctr, Providence, RI USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2013年 / 369卷 / 14期

关键词：

RISK;

D O I：

10.1056/NEJMp1309610

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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) ...

引用

页码：1285 / 1287

页数：3

共 5 条

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