Premature Release of Data from Clinical Trials of Ezetimibe

被引：24

作者：

Califf, Robert M. ^{[1
]}

Harrington, Robert A. ^{[2
]}

Blazing, Michael A. ^{[2
]}

机构：

[1] Duke Translat Med Inst, Durham, NC USA

[2] Duke Clin Res Inst, Durham, NC USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2009年 / 361卷 / 07期

关键词：

SIMVASTATIN;

D O I：

10.1056/NEJMsr0900910

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The authors describe the unexpected finding of a cancer risk in ongoing clinical trials of the cholesterol-lowering drug ezetimibe. They discuss the implications of these events for how we address new, unanticipated scientific evidence, especially in the area of drug safety. Copyright © 2009 Massachusetts Medical Society.

引用

页码：712 / 717

页数：6

共 15 条

[1] Study of Heart and Renal Protection (SHARP) [J].

Baigent, C ;

Landry, M .

KIDNEY INTERNATIONAL, 2003, 63 :S207-S210

[2] C-reactive protein and coronary heart disease: a critical review [J].

Casas, J. P. ;

Shah, T. ;

Hingorani, A. D. ;

Danesh, J. ;

Pepys, M. B. .

JOURNAL OF INTERNAL MEDICINE, 2008, 264 (04) :295-314

[3] The discovery of ezetimibe: A view from outside the receptor [J].

Clader, JW .

JOURNAL OF MEDICINAL CHEMISTRY, 2004, 47 (01) :1-9

[4]

*CLINICALTRIALS GO, NCT00202878 CLINICAL

[5]

DeMets David L, 2004, Clin Trials, V1, P525, DOI 10.1191/1740774504cn54oa

[6]

*DIV MET END DRUG, 1990, GUID CLIN EV LIP ALT

[7] Identifying and addressing safety signals in clinical trials [J].

Fleming, Thomas R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2008, 359 (13) :1400-1402

[8]

Meng C Q, 2001, Curr Opin Investig Drugs, V2, P389

[9] Analyses of cancer data from three Ezetimibe trials [J].

Peto, Richard ;

Emberson, Jonathan ;

Landray, Martin ;

Baigent, Colin ;

Collins, Rory ;

Clare, Robert ;

Califf, Robert .

NEW ENGLAND JOURNAL OF MEDICINE, 2008, 359 (13) :1357-1366

[10] Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial [J].

Ridker, Paul M. ;

Danielson, Eleanor ;

Fonseca, Francisco A. H. ;

Genest, Jacques ;

Gotto, Antonio M., Jr. ;

Kastelein, John J. P. ;

Koenig, Wolfgang ;

Libby, Peter ;

Lorenzatti, Alberto J. ;

MacFadyen, Jean G. ;

Nordestgaard, Borge G. ;

Shepherd, James ;

Willerson, James T. ;

Glynn, Robert J. .

LANCET, 2009, 373 (9670) :1175-1182

← 1 2 →