FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 347:1030-1034 September 26, 2002 Number 13 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Purchase this article Perspective by Wenzel, R. P. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

In 2001, the Food and Drug Administration (FDA) evaluated an application for the use of drotrecogin alfa (activated), or recombinant human activated protein C (Xigris, Eli Lilly), in patients with severe sepsis. The use of activated protein C, as compared with placebo, was associated with a significant reduction in mortality in the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial (24.7 percent vs. 30.8 percent, P=0.005).¹ Extensive review by physicians and scientists at the FDA confirmed the principal findings of the PROWESS trial but raised issues regarding the interpretation of data and appropriate use of the . . . [Full Text of this Article]

Changes during the Trial

Patients with Serious Preexisting Diseases

End Points

Changes in the Product

Use of the Apache II Score

Risk of Bleeding and Survival Benefits

Conclusions

Related Letters:

Activated Protein C for Severe Sepsis
Ely E. W., Bernard G. R., Vincent J.-L.
Extract | Full Text | PDF  
N Engl J Med 2002; 347:1035-1036, Sep 26, 2002. Correspondence

This article has been cited by other articles:

• Chen, H.-W., Kuo, H.-T., Chai, C.-Y., Ou, J.-L., Yang, R.-C. (2007). Pretreatment of curcumin attenuates coagulopathy and renal injury in LPS-induced endotoxemia. Innate Immunity 13: 15-23 [Abstract]  
• Dombrovskiy, V., Martin, A., Sunderram, J., Paz, H. (2006). Use of drotrecogin alfa (activated) for severe sepsis in New Jersey acute care hospitals.. Am J Health Syst Pharm 63: 1151-1156 [Abstract] [Full Text]  
• Friedrich, J. O., LaRosa, S. P., Baillie, J.K., Murray, G., Abraham, E., Laterre, P.-F. (2006). Drotrecogin Alfa (Activated) in Severe Sepsis. NEJM 354: 94-96 [Full Text]  
• Rivers, E. P., McIntyre, L., Morro, D. C., Rivers, K. K. (2005). Early and innovative interventions for severe sepsis and septic shock: taking advantage of a window of opportunity. CMAJ 173: 1054-1065 [Abstract] [Full Text]  
• Abraham, E., Laterre, P.-F., Garg, R., Levy, H., Talwar, D., Trzaskoma, B. L., Francois, B., Guy, J. S., Bruckmann, M., Rea-Neto, A., Rossaint, R., Perrotin, D., Sablotzki, A., Arkins, N., Utterback, B. G., Macias, W. L., the Administration of Drotrecogin Alfa (Activated), (2005). Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death.. NEJM 353: 1332-1341 [Abstract] [Full Text]  
• Parrillo, J. E. (2005). Severe sepsis and therapy with activated protein C.. NEJM 353: 1398-1400 [Full Text]  
• Knaus, W. A. (2005). Designing Trials and Deciding on Therapy in Complex Diseases: What Can We Do to Improve?. Med Decis Making 25: 366-369  
• Johnston, J. A. (2005). Determinants of Mortality in Patients with Severe Sepsis. Med Decis Making 25: 374-386 [Abstract]  
• Bernard, G. R., Margolis, B. D., Shanies, H. M., Ely, E. W., Wheeler, A. P., Levy, H., Wong, K., Wright, T. J. (2004). Extended Evaluation of Recombinant Human Activated Protein C United States Trial (ENHANCE US): A Single-Arm, Phase 3B, Multicenter Study of Drotrecogin Alfa (Activated) in Severe Sepsis. Chest 125: 2206-2216 [Abstract] [Full Text]  
• Graham, P. L., Cook, D. A. (2004). Prediction of Risk of Death Using 30-Day Outcome: A Practical End Point for Quality Auditing in Intensive Care. Chest 125: 1458-1466 [Abstract] [Full Text]  
• Easby, J., Greaves, I. (2004). Current concepts in the diagnosis and management of trauma-related sepsis. Trauma 6: 1-11 [Abstract]  
• Dettenmeier, P., Swindell, B., Stroud, M., Arkins, N., Howard, A. (2003). Role of Activated Protein C in the Pathophysiology of Severe Sepsis. Am J Crit Care 12: 518-524 [Abstract] [Full Text]  
• Abraham, E., Reinhart, K., Opal, S., Demeyer, I., Doig, C., Rodriguez, A. L., Beale, R., Svoboda, P., Laterre, P. F., Simon, S., Light, B., Spapen, H., Stone, J., Seibert, A., Peckelsen, C., De Deyne, C., Postier, R., Pettila, V., Artigas, A., Percell, S. R., Shu, V., Zwingelstein, C., Tobias, J., Poole, L., Stolzenbach, J. C., Creasey, A. A. (2003). Efficacy and Safety of Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) in Severe Sepsis: A Randomized Controlled Trial. JAMA 290: 238-247 [Abstract] [Full Text]  
• Hotchkiss, R. S., Karl, I. E. (2003). The Pathophysiology and Treatment of Sepsis. NEJM 348: 138-150 [Full Text]  
• (2002). Activated Protein C -- How Should We Use It to Treat Sepsis?. JWatch Infect. Diseases 2002: 3-3 [Full Text]  
• (2002). Debate on Xigris Heats Up. JWatch General 2002: 4-4 [Full Text]  
• Ely, E. W., Bernard, G. R., Vincent, J.-L. (2002). Activated Protein C for Severe Sepsis. NEJM 347: 1035-1036 [Full Text]