Assessing the use of activated protein C in the treatment of severe sepsis

New England Journal of Medicine

Volumn 347, Issue 13, 2002, Pages 1030-1034

  Siegel, Jay P ^a  

^a Center for Biologics Evaluation/Res   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVATED PROTEIN C; BROPHY G; DROTRECOGIN;

ARTICLE; BLEEDING; CLINICAL TRIAL; DISEASE SEVERITY; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SEPSIS; SURVIVAL RATE; TREATMENT OUTCOME;

ANTI-INFECTIVE AGENTS; APACHE; CELL LINE; CLINICAL TRIALS; COMORBIDITY; DRUG APPROVAL; HEMORRHAGE; HUMANS; PROTEIN C; RECOMBINANT PROTEINS; SEPSIS; SURVIVAL ANALYSIS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0037179705     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMsb021512     Document Type: Article

References (6)

1. Bernard GR, Vincent J-L, Laterre P-F, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001;344:699-709.
2. Anti-Infective Advisory Committee. FDA briefing document: drotrecogin alfa (activated) [recombinant human activated protein C (rhAPC)] Xigris, BLA#125029/0. Rockville, Md.: Food and Drug Administration, September 12, 2001. (Accessed September 6, 2002, at http://www.fda.gov/ ohrms/dockcts/ac/01/briefing/3797b1_02_FDAbriefing.doc.)
3. [Transcripts of the meeting of the] Anti-Infective Drugs Advisory Committee meeting. Rockville, Md.: Food and Drug Administration, October 16, 2001. (Accessed September 6, 2002, at http://www.fda.gov/ohrms/ dockets/ac/01/transcripts/3797t1.doc.)
4. Warren HS, Suffredini AF, Eichackcr PQ, Munford RS. Risks and benefits of activated protein C treatment for severe sepsis. N Engl J Med 2002; 347:1027-30.
5. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985;13:818-29.
6. FDA clinical review: drotrecogin alfa (activated) [recombinant human activated protein C (rhAPC)] Xigris. Rockville, Md.: Food and Drug Administration (in press).