Regulatory Action on Rosiglitazone by the US Food and Drug Administration

被引：114

作者：

Woodcock, Janet ^{[1
]}

Sharfstein, Joshua M. ^{[2
]}

Hamburg, Margaret ^{[2
]}

机构：

[1] Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Dept Hlth & Human Serv, Silver Spring, MD USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2010年 / 363卷 / 16期

关键词：

D O I：

10.1056/NEJMp1010788

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页码：1489 / 1491

页数：3

共 6 条

[1] Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial [J].

Home, Philip D. ;

Pocock, Stuart J. ;

Beck-Nielsen, Henning ;

Curtis, Paula S. ;

Gomis, Ramon ;

Hanefeld, Markolf ;

Jones, Nigel P. ;

Komajda, Michel ;

McMurray, John J. V. .

LANCET, 2009, 373 (9681) :2125-2135

[2]

Nissen SE, 2007, NEW ENGL J MED, V357, P100

[3] Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes (vol 356, pg 2457, 2007) [J].

Nissen, Steven E. ;

Wolski, Kathy .

NEW ENGLAND JOURNAL OF MEDICINE, 2007, 356 (24) :2457-2471

[4] Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) [J].

Turner, RC ;

Holman, RR ;

Stratton, IM ;

Cull, CA ;

Matthews, DR ;

Manley, SE ;

Frighi, V ;

Wright, D ;

Neil, A ;

Kohner, E ;

McElroy, H ;

Fox, C ;

Hadden, D .

LANCET, 1998, 352 (9131) :854-865

[5]

U.S. Food and Drug Administration, GUID IND DIAB MELL E

[6]

US Food & Drug Administration, FDA DRUG SAF COMM ON

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