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Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis.

Bernard GR, Macias WL, Joyce DE, Williams MD, Bailey J, Vincent JL.

Crit Care. 2003 Apr;7(2):155-63. Epub 2003 Feb 28. Review.PMID: 12720562 [PubMed - indexed for MEDLINE]Related articlesFree article

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.

Bernard GR, Margolis BD, Shanies HM, Ely EW, Wheeler AP, Levy H, Wong K, Wright TJ; Extended Evaluation of Recombinant Human Activated Protein C United States Investigators.

Chest. 2004 Jun;125(6):2206-16.PMID: 15189943 [PubMed - indexed for MEDLINE]Related articlesFree article

International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: analysis of efficacy and safety data in a large surgical cohort.

Payen D, Sablotzki A, Barie PS, Ramsay G, Lowry S, Williams M, Sarwat S, Northrup J, Toland P, McL Booth FV.

Surgery. 2006 Nov;140(5):726-39. Corrected and republished in: Surgery. 2007 Apr;141(4):548-61. PMID: 17084715 [PubMed - indexed for MEDLINE]Related articles

International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: analysis of efficacy and safety data in a large surgical cohort.

Payen D, Sablotzki A, Barie PS, Ramsay G, Lowry S, Williams M, Sarwat S, Northrup J, Toland P, Booth FV.

Surgery. 2007 Apr;141(4):548-61.PMID: 17431957 [PubMed - indexed for MEDLINE]Related articles

Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: further evidence for survival and safety and implications for early treatment.

Vincent JL, Bernard GR, Beale R, Doig C, Putensen C, Dhainaut JF, Artigas A, Fumagalli R, Macias W, Wright T, Wong K, Sundin DP, Turlo MA, Janes J.

Crit Care Med. 2005 Oct;33(10):2266-77.PMID: 16215381 [PubMed - indexed for MEDLINE]Related articles

Drotrecogin alfa (activated) administration across clinically important subgroups of patients with severe sepsis.

Ely EW, Laterre PF, Angus DC, Helterbrand JD, Levy H, Dhainaut JF, Vincent JL, Macias WL, Bernard GR; PROWESS Investigators.

Crit Care Med. 2003 Jan;31(1):12-9.PMID: 12544987 [PubMed - indexed for MEDLINE]Related articles

ENHANCE: results of a global open-label trial of drotrecogin alfa (activated) in children with severe sepsis.

Goldstein B, Nadel S, Peters M, Barton R, Machado F, Levy H, Haney DJ, Utterback B, Williams MD, Giroir BP.

Pediatr Crit Care Med. 2006 May;7(3):200-11.PMID: 16575354 [PubMed - indexed for MEDLINE]Related articles

Safety of drotrecogin alfa (activated) in surgical patients with severe sepsis.

Fry DE, Beilman G, Johnson S, Williams MD, Rodman G, Booth FV, Bates BM, McCollam JS, Lowry SF; PROWESS Surgical Evaluation Committee.

Surg Infect (Larchmt). 2004 Fall;5(3):253-9.PMID: 15684796 [PubMed - indexed for MEDLINE]Related articles

Drotrecogin alfa (activated) in patients with severe sepsis presenting with purpura fulminans, meningitis, or meningococcal disease: a retrospective analysis of patients enrolled in recent clinical studies.

Vincent JL, Nadel S, Kutsogiannis DJ, Gibney RT, Yan SB, Wyss VL, Bailey JE, Mitchell CL, Sarwat S, Shinall SM, Janes JM.

Crit Care. 2005 Aug;9(4):R331-43. Epub 2005 May 17.PMID: 16137345 [PubMed - indexed for MEDLINE]Related articlesFree article

Safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in children with severe sepsis.

Barton P, Kalil AC, Nadel S, Goldstein B, Okhuysen-Cawley R, Brilli RJ, Takano JS, Martin LD, Quint P, Yeh TS, Dalton HJ, Gessouron MR, Brown KE, Betts H, Levin M, Macias WL, Small DS, Wyss VL, Bates BM, Utterback BG, Giroir BP.

Pediatrics. 2004 Jan;113(1 Pt 1):7-17.PMID: 14702440 [PubMed - indexed for MEDLINE]Related articlesFree article

A retrospective observational study of drotrecogin alfa (activated) in adults with severe sepsis: comparison with a controlled clinical trial.

Wheeler A, Steingrub J, Schmidt GA, Sanchez P, Jacobi J, Linde-Zwirble W, Bates B, Qualy RL, Woodward B, Zeckel M.

Crit Care Med. 2008 Jan;36(1):14-23.PMID: 18158435 [PubMed - indexed for MEDLINE]Related articles

Safety of drotrecogin alfa (activated) in the treatment of patients with severe sepsis.

McCoy C.

Expert Opin Drug Saf. 2004 Nov;3(6):625-37. Review.PMID: 15500421 [PubMed - indexed for MEDLINE]Related articles

Clinical effectiveness and cost-effectiveness of drotrecogin alfa (activated) (Xigris) for the treatment of severe sepsis in adults: a systematic review and economic evaluation.

Green C, Dinnes J, Takeda A, Shepherd J, Hartwell D, Cave C, Payne E, Cuthbertson BH.

Health Technol Assess. 2005 Mar;9(11):1-126, iii-iv.PMID: 15774234 [PubMed - indexed for MEDLINE]Related articlesFree article

Benefit/risk profile of drotrecogin alfa (activated) in surgical patients with severe sepsis.

Barie PS, Williams MD, McCollam JS, Bates BM, Qualy RL, Lowry SF, Fry DE; PROWESS Surgical Evaluation Committee.

Am J Surg. 2004 Sep;188(3):212-20.PMID: 15450822 [PubMed - indexed for MEDLINE]Related articles

Adverse outcomes associated with the use of drotrecogin alfa (activated) in patients with severe sepsis and baseline bleeding precautions.

Gentry CA, Gross KB, Sud B, Drevets DA.

Crit Care Med. 2009 Jan;37(1):19-25.PMID: 19050637 [PubMed - indexed for MEDLINE]Related articles

Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death.

Abraham E, Laterre PF, Garg R, Levy H, Talwar D, Trzaskoma BL, François B, Guy JS, Brückmann M, Rea-Neto A, Rossaint R, Perrotin D, Sablotzki A, Arkins N, Utterback BG, Macias WL; Administration of Drotrecogin Alfa (Activated) in Early Stage Severe Sepsis (ADDRESS) Study Group.

N Engl J Med. 2005 Sep 29;353(13):1332-41.PMID: 16192478 [PubMed - indexed for MEDLINE]Related articlesFree article

Efficacy and safety of drotrecogin alfa (activated) for the therapy of surgical patients with severe sepsis.

Barie PS, Hydo LJ, Shou J, Eachempati SR.

Surg Infect (Larchmt). 2006;7 Suppl 2:S77-80. Review.PMID: 16895513 [PubMed - indexed for MEDLINE]Related articles

Drotrecogin alfa: a second look. More clinical trials in severe sepsis: mostly negative results.

[No authors listed]

Prescrire Int. 2007 Feb;16(87):7-9.PMID: 17323514 [PubMed - indexed for MEDLINE]Related articles

Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: data from the PROWESS trial.

Dhainaut JF, Laterre PF, Janes JM, Bernard GR, Artigas A, Bakker J, Riess H, Basson BR, Charpentier J, Utterback BG, Vincent JL; Recombinant Human Activated Protein C Worldwide Evaluation in Sepsis (PROWESS) Study Group.

Intensive Care Med. 2003 Jun;29(6):894-903. Epub 2003 Apr 24.PMID: 12712239 [PubMed - indexed for MEDLINE]Related articles

Efficacy and safety of recombinant human activated protein C for severe sepsis.

Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr; Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group.

N Engl J Med. 2001 Mar 8;344(10):699-709.PMID: 11236773 [PubMed - indexed for MEDLINE]Related articlesFree article