Recombinant human activated protein C in sepsis: Inconsistent trial results, an unclear mechanism of action, and safety concerns resulted in labeling restrictions and the need for phase IV trials

被引:49
作者
Eichacker, PQ [1 ]
Natanson, C [1 ]
机构
[1] NIH, Dept Crit Care Med, Warren G Magnuson Clin Ctr, Bethesda, MD 20892 USA
关键词
D O I
10.1097/00003246-200301001-00013
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
引用
收藏
页码:S94 / S96
页数:3
相关论文
共 8 条
[1]   Assessment of the safety of recombinant tissue factor pathway inhibitor in patients with severe sepsis: A multicenter, randomized, placebo-controlled, single-blind, dose escalation study [J].
Abraham, E ;
Reinhart, K ;
Svoboda, P ;
Seibert, A ;
Olthoff, D ;
Dal Nogare, A ;
Postier, R ;
Hempelmann, G ;
Butler, T ;
Martin, E ;
Zwingelstein, C ;
Percell, S ;
Shu, V ;
Leighton, A ;
Creasey, AA .
CRITICAL CARE MEDICINE, 2001, 29 (11) :2081-2089
[2]   Efficacy and safety of recombinant human activated protein C for severe sepsis. [J].
Bernard, GR ;
Vincent, JL ;
Laterre, P ;
LaRosa, SP ;
Dhainaut, JF ;
Lopez-Rodriguez, A ;
Steingrub, JS ;
Garber, GE ;
Helterbrand, JD ;
Ely, EW ;
Fisher, CJ .
NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (10) :699-709
[3]   Risk and the efficacy of antiinflammatory agents - Retrospective and confirmatory studies of sepsis [J].
Eichacker, PQ ;
Parent, C ;
Kalil, A ;
Esposito, C ;
Cui, X ;
Banks, SM ;
Gerstenberger, EP ;
Fitz, Y ;
Danner, RL ;
Natanson, C .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2002, 166 (09) :1197-1205
[4]  
*FDA, FDA BRIEF DOC ANT CO
[5]   Recombinant human activated protein C attenuates the inflammatory response in endothelium and monocytes by modulating nuclear factor-κB [J].
Joyce, DE ;
Grinnell, BW .
CRITICAL CARE MEDICINE, 2002, 30 (05) :S288-S293
[6]   Severe sepsis - A new treatment with both anticoagulant and antiinflammatory properties. [J].
Matthay, MA .
NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (10) :759-762
[7]  
OKIE S, 2001, WASHINGTONPOST 1019, pA2
[8]   High-dose a randomized antithrombin III in severe sepsis -: A randomized controlled trial [J].
Warren, BL ;
Eid, A ;
Singer, P ;
Pillay, SS ;
Carl, P ;
Novak, I ;
Chalupa, P ;
Atherstone, A ;
Pénzes, I ;
Kübler, A ;
Knaub, S ;
Keinecke, HO ;
Heinrichs, H ;
Schindel, F ;
Juers, M ;
Bone, RC ;
Opal, SM .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2001, 286 (15) :1869-1878