Bibliography
- BRUN-BUISSON C, MESHAKA P, PINTON P, VALLET B; EPISEPSIS Study Group: EPISEPSIS a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. (2004) 30:580-588.
- ZAHOREC R, FIRMENT J, STRAKOVA J et al.: Epidemiology of severe sepsis in intensive care units in the Slovak Republic. Infection (2005) 33:122-128.
- FINFER S, BELLOMO R, LIPMAN J, FRENCH C, DOBB G, MYBURGH J: Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med. (2004) 30:589-596.
- ENGEL C, BRUNKHORST FM, BONE HG et al.: Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. (2007) 33:606-618.
- VAN GESTEL A, BAKKER J, VERAART CP, VAN HOUT BA: Prevalence and incidence of severe sepsis in Dutch intensive care units. Crit. Care (2004) 8:R153-R162.
- PADKIN A, GOLDFRAD C, BRADY AR, YOUNG D, BLACK N, ROWAN K: Epidemiology of severe sepsis occurring in the first 24 h in intensive care units in England, Wales, and Northern Ireland. Crit. Care Med. (2003) 31:2332-2338.
- KARLSSON S, VARPULA M, RUOKONEN E et al.: Incidence, treatment, and outcome of severe sepsis in ICU-treated adults in Finland: the Finnsepsis study. Intensive Care Med. (2007) 33(3):435-443.
- WATSON RS, CARCILLO JA, LINDE-ZWIRBLE WT, CLERMONT G, LIDICKER J, ANGUS DC: The epidemiology of severe sepsis in children in the United States. Am. J. Respir. Crit. Care Med. (2003) 167:695-701.
- VINCENT JL, SAKR Y, SPRUNG CL et al.: Sepsis in European intensive care units: results of the SOAP study. Crit. Care Med. (2006) 34:344-353.
- HERON MP, SMITH BL: Deaths: leading causes for 2003. Natl. Vital. Stat. Rep. (2007) 55:1-92.
- DOMBROVSKIY VY, MARTIN AA, SUNDERRAM J, PAZ HL: Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit. Care Med. (2007) 35:1244-1250.
- MARTIN GS, MANNINO DM, EATON S, MOSS M: The epidemiology of sepsis in the United States from 1979 through 2000. N. Engl. J. Med. (2003) 348:1546-1554.
- HARRISON DA, WELCH CA, EDDLESTON JM: The epidemiology of severe sepsis in England, Wales and Northern Ireland, 1996 to 2004: secondary analysis of a high quality clinical database, the ICNARC case mix programme database. Crit. Care (2006) 10:R42.
- DOMBROVSKIY VY, MARTIN AA, SUNDERRAM J, PAZ HL: Facing the challenge: decreasing case fatality rates in severe sepsis despite increasing hospitalizations. Crit. Care Med. (2005) 33:2555-2562.
- DELLINGER RP, CARLET JM, MASUR H et al.: Surviving sepsis campaign guidelines for management of severe sepsis and septic shock. Crit. Care Med. (2004) 32:858-873.
- VINCENT JL, SUN Q, DUBOIS MJ: Clinical trials of immunomodulatory therapies in severe sepsis and septic shock. Clin. Infect. Dis. (2002) 34:1084-1093.
- VINCENT JL, COHEN J: Another antiendotoxin strategy to be added to the list. Crit. Care Med. (1997) 25:1949-1950.
- COHEN J, CARLET J: INTERSEPT: an international, multicenter, placebo-controlled trial of monoclonal antibody to human TNF-α in patients with sepsis. International Sepsis Trial Study Group. Crit. Care Med. (1996) 24:1431-1440.
- ABRAHAM E, ANZUETO A, GUTIERREZ G et al.: Double-blind randomised controlled trial of monoclonal antibody to human tumour necrosis factor in treatment of septic shock. Lancet (1998) 351:929-933.
- RONCO C, INGUAGGIATO P, D'INTINI V et al.: The role of extracorporeal therapies in sepsis. J. Nephrol. (2003) 16(Suppl. 7):S34-S41.
- BERNARD GR, VINCENT JL, LATERRE PF et al.: Efficacy and safety of recombinant human activated protein C for severe sepsis. N. Engl. J. Med. (2001) 344:699-709.
- WARREN BL, EID A, SINGER P et al.: Caring for the critically ill patient. High-dose antithrombin III in severe sepsis: a randomized controlled trial. JAMA (2001) 286:1869-1878.
- ABRAHAM E, REINHART K, OPAL S et al.: Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA (2003) 290:238-247.
- ESMON CT: The protein C pathway. Chest (2003) 124:S26-S32.
- ESMON CT: Inflammation and the activated protein C anticoagulant pathway. Semin. Thromb. Hemost. (2006) 32(Suppl. 1):49-60.
- KRISHNAMURTI C, YOUNG GD, BARR CF, COLLETON CA, ALVING BM: Enhancement of tissue plasminogen activator-induced fibrinolysis by activated protein C in endotoxin-treated rabbits. J. Lab. Clin. Med. (1991) 118:523-530.
- BAJZAR L, NESHEIM ME, TRACY PB: The profibrinolytic effect of activated protein C in clots formed from plasma is TAFI-dependent. Blood (1996) 88:2093-2100.
- STENFLO J: A new vitamin K-dependent protein. Purification from bovine plasma and preliminary characterization. J. Biol. Chem. (1976) 251:355-363.
- KISIEL W: Human plasma protein C: isolation, characterization, and mechanism of activation by α-thrombin. J. Clin. Invest. (1979) 64:761-769.
- HESSELVIK JF, MALM J, DAHLBACK B, BLOMBACK M: Protein C, protein S and C4b-binding protein in severe infection and septic shock. Thromb. Haemost. (1991) 65:126-129.
- FOURRIER F, CHOPIN C, GOUDEMAND J et al.: Septic shock, multiple organ failure, and disseminated intravascular coagulation. Compared patterns of antithrombin III, protein C, and protein S deficiencies. Chest (1992) 101:816-823.
- LECLERC F, HAZELZET J, JUDE B et al.: Protein C and S deficiency in severe infectious purpura of children: a collaborative study of 40 cases. Intensive Care Med. (1992) 18:202-205.
- MESTERS RM, HELTERBRAND J, UTTERBACK BG et al.: Prognostic value of protein C concentrations in neutropenic patients at high risk of severe septic complications. Crit. Care Med. (2000) 28:2209-2216.
- YAN SB, HELTERBRAND JD, HARTMAN DL, WRIGHT TJ, BERNARD GR: Low levels of protein C are associated with poor outcome in severe sepsis. Chest (2001) 120:915-922.
- MACIAS WL, NELSON DR: Severe protein C deficiency predicts early death in severe sepsis. Crit. Care Med. (2004) 32:S223-S228.
- SHORR AF, BERNARD GR, DHAINAUT JF et al.: Protein C concentrations in severe sepsis: an early directional change in plasma levels predicts outcome. Crit. Care (2006) 10:R92.
- BRUNKHORST F, SAKR Y, HAGEL S, REINHART K: Protein C concentrations correlate with organ dysfunction and predict outcome independent of the presence of sepsis. Anesthesiology (2007) 107:15-23.
- GERSON WT, DICKERMAN JD, BOVILL EG, GOLDEN E: Severe acquired protein C deficiency in purpura fulminans associated with disseminated intravascular coagulation: treatment with protein C concentrate. Pediatrics (1993) 91:418-422.
- RIVARD GE, DAVID M, FARRELL C, SCHWARZ HP: Treatment of purpura fulminans in meningococcemia with protein C concentrate. J. Pediatr. (1995) 126:646-652.
- SMITH OP, WHITE B, VAUGHAN D et al.: Use of protein-C concentrate, heparin, and haemodiafiltration in meningococcus-induced purpura fulminans. Lancet (1997) 350:1590-1593.
- ETTINGSHAUSEN CE, VELDMANN A, BEEG T, SCHNEIDER W, JAGER G, KREUZ W: Replacement therapy with protein C concentrate in infants and adolescents with meningococcal sepsis and purpura fulminans. Semin. Thromb. Hemost. (1999) 25:537-541.
- RINTALA E, KAUPPILA M, SEPPALA OP et al.: Protein C substitution in sepsis-associated purpura fulminans. Crit. Care Med. (2000) 28:2373-2378.
- LECLERC F, CREMER R, LETEURTRE S, MARTINOT A, FOURIER C: Protein C concentrate and recombinant tissue plasminogen activator in meningococcal septic shock. Crit. Care Med. (2000) 28:1694-1697.
- LIAW PC: Endogenous protein C activation in patients with severe sepsis. Crit. Care Med. (2004) 32:S214-S218.
- YAN SB, DHAINAUT JF: Activated protein C versus protein C in severe sepsis. Crit. Care Med. (2001) 29:S69-S74.
- FAUST SN, LEVIN M, HARRISON OB et al.: Dysfunction of endothelial protein C activation in severe meningococcal sepsis. N. Engl. J. Med. (2001) 345:408-416.
- GRINNELL BW, JOYCE D: Recombinant human activated protein C: a system modulator of vascular function for treatment of severe sepsis. Crit. Care Med. (2001) 29:S53-S61.
- DERHASCHNIG U, REITER R, KNOBL P, BAUMGARTNER M, KEEN P, JILMA B: Recombinant human activated protein C (rhAPC; drotrecogin alfa [activated]) has minimal effect on markers of coagulation, fibrinolysis, and inflammation in acute human endotoxemia. Blood (2003) 102:2093-2098.
- KALIL AC, COYLE SM, UM JY et al.: Effects of drotrecogin alfa (activated) in human endotoxemia. Shock (2004) 21:222-229.
- DHAINAUT JF, YAN SB, MARGOLIS BD et al.: Drotrecogin alfa (activated) (recombinant human activated protein C) reduces host coagulopathy response in patients with severe sepsis. Thromb. Haemost. (2003) 90:642-653.
- DE PONT AC, BAKHTIARI K, HUTTEN BA et al.: Recombinant human activated protein C resets thrombin generation in patients with severe sepsis – a case control study. Crit. Care (2005) 9:R490-R497.
- MACIAS WL, YAN SB, WILLIAMS MD et al.: New insights into the protein C pathway: potential implications for the biological activities of drotrecogin alfa (activated). Crit. Care (2005) 9(Suppl. 4):S38-S45.
- WHITE B, SCHMIDT M, MURPHY C et al.: Activated protein C inhibits lipopolysaccharide-induced nuclear translocation of nuclear factor κB (NF-κB) and tumour necrosis factor α (TNF-α) production in the THP-1 monocytic cell line. Br. J. Haematol. (2000) 110:130-134.
- LOONEY MR, MATTHAY MA: Bench-to-bedside review: the role of activated protein C in maintaining endothelial tight junction function and its relationship to organ injury. Crit. Care (2006) 10:239.
- MOSNIER LO, ZLOKOVIC BV, GRIFFIN JH: The cytoprotective protein C pathway. Blood (2007) 109:3161-3172.
- ZENG W, MATTER WF, YAN SB, UM SL, VLAHOS CJ, LIU L: Effect of drotrecogin alfa (activated) on human endothelial cell permeability and Rho kinase signalling. Crit. Care Med. (2004) 32:S302-S308.
- FINIGAN JH, DUDEK SM, SINGLETON PA et al.: Activated protein C mediates novel lung endothelial barrier enhancement: role of sphingosine 1-phosphate receptor transactivation. J. Biol. Chem. (2005) 280:17286-17293.
- STURN DH, KANEIDER NC, FEISTRITZER C, DJANANI A, FUKUDOME K, WIEDERMANN CJ: Expression and function of the endothelial protein C receptor in human neutrophils. Blood (2003) 102:1499-1505.
- NICK JA, COLDREN CD, GERACI MW et al.: Recombinant human activated protein C reduces human endotoxin-induced pulmonary inflammation via inhibition of neutrophil chemotaxis. Blood (2004) 104:3878-3885.
- HOFFMANN JN, VOLLMAR B, LASCHKE MW, FERTMANN JM, JAUCH KW, MENGER MD: Microcirculatory alterations in ischaemia–reperfusion injury and sepsis: effects of activated protein C and thrombin inhibition. Crit. Care (2005) 9(Suppl. 4):S33-S37.
- IBA T, KIDOKORO A, FUKUNAGA M, NAGAKARI K, SHIRAHAMA A, IDA Y: Activated protein C improves the visceral microcirculation by attenuating the leukocyte-endothelial interaction in a rat lipopolysaccharide model. Crit. Care Med. (2005) 33:368-372.
- BILBAULT P, LAVAUX T, LAUNOY A et al.: Influence of drotrecogin alfa (activated) infusion on the variation of Bax/Bcl-2 and Bax/Bcl-xl ratios in circulating mononuclear cells: a cohort study in septic shock patients. Crit. Care Med. (2007) 35:69-75.
- MOSNIER LO, GRIFFIN JH: Inhibition of staurosporine-induced apoptosis of endothelial cells by activated protein C requires protease activated receptor-1 and endothelial cell protein C receptor. Biochem. J. (2003) 373:65-70.
- DE BACKER D, VERDANT C, CHIEREGO M, KOCH M, GULLO A, VINCENT JL: Effects of drotrecogin alfa activated on microcirculatory alterations in patients with severe sepsis. Crit. Care Med. (2006) 34:1918-1924.
- BERNARD GR, ELY EW, WRIGHT TJ et al.: Safety and dose relationship of recombinant human activated protein C for coagulopathy in severe sepsis. Crit. Care Med. (2001) 29:2051-2059.
- LEVY H, SMALL D, HEISELMAN DE et al.: Obesity does not alter the pharmacokinetics of drotrecogin alfa (activated) in severe sepsis. Ann. Pharmacother. (2005) 39:262-267.
- TAYLOR FB, CHANG A, ESMON CT, D'ANGELO A, VIGANO-D'ANGELO S, BLICK KE: Protein C prevents the coagulopathic and lethal effects of E. coli in the baboon. J. Clin. Invest. (1987) 79:918-924.
- MURAKAMI K, OKAJIMA K, UCHIBA M et al.: Activated protein C prevents LPS-induced pulmonary vascular injury by inhibiting cytokine production. Am. J. Physiol. (1997) 272:L197-L202.
- MURAKAMI K, OKAJIMA K, UCHIBA M et al.: Activated protein C attenuates endotoxin-induced pulmonary vascular injury by inhibiting activated leukocytes in rats. Blood (1996) 87:642-647.
- ROBACK MG, STACK AM, THOMPSON C, BRUGNARA C, SCHWARZ HP, SALADINO RA: Activated protein C concentrate for the treatment of meningococcal endotoxin shock in rabbits. Shock (1998) 9:138-142.
- WARREN HS, SUFFREDINI AF, EICHACKER PQ, MUNFORD RS: Risks and benefits of activated protein C treatment for severe sepsis. N. Engl. J. Med. (2002) 347:1027-1030.
- SIEGEL JP: Assessing the use of activated protein C in the treatment of severe sepsis. N. Engl. J. Med. (2002) 347:1030-1034.
- MACIAS WL, VALLET B, BERNARD GR et al.: Sources of variability on the estimate of treatment effect in the PROWESS trial: implications for the design and conduct of future studies in severe sepsis. Crit. Care Med. (2004) 32:2385-2391.
- VINCENT JL, ANGUS DC, ARTIGAS A et al.: Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial. Crit. Care Med. (2003) 31:834-840.
- ANGUS DC, LATERRE PF, HELTERBRAND J et al.: The effect of drotrecogin alfa (activated) on long-term survival after severe sepsis. Crit. Care Med. (2004) 32:2199-2206.
- VINCENT JL, BERNARD GR, BEALE R et al.: Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE. Crit. Care Med. (2005) 33:2266-2277.
- ABRAHAM E, LATERRE PF, GARG R et al.: Drotrecogin alfa [activated] for adults with severe sepsis and a low risk of death. N. Engl. J. Med. (2005) 353:1332-1341.
- NADEL S, GOLDSTEIN B, WILLIAMS MD et al.: Drotrecogin alfa (activated) in children with severe sepsis: a multi-centre Phase III randomised controlled trial. Lancet (2007) 369:836-843.
- BARTON P, KALIL AC, NADEL S et al.: Safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in children with severe sepsis. Pediatrics (2004) 113:7-17.
- OPAL SM: Can we RESOLVE the treatment of sepsis? Lancet (2007) 369:803-804.
- LEVI M, LEVY M, WILLIAMS MD et al.: Prophylactic heparin in patients with severe sepsis treated with drotrecogin alfa (activated). Am. J. Respir. Crit. Care Med. (2007) 176:483-490.
- BERNARD GR, MACIAS WL, JOYCE DE, WILLIAMS MD, BAILEY J, VINCENT JL: Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis. Crit. Care (2003) 7:155-163.
- FARMER JC: Drotrecogin alfa (activated) treatment in severe sepsis: a ‘journal club’ review of the global ENHANCE trial. Crit. Care Med. (2005) 33:2428-2431.
- DE PONT AC, BAKX R, BOERMEESTER MA, SCHULTZ MJ: Analysis of efficacy and safety of drotrecogin alfa (activated) in surgical patients, using an international integrated database. Surgery (2007) 141:828-829.
- GREEN C, DINNES J, TAKEDA A et al.: Clinical effectiveness and cost-effectiveness of drotrecogin alfa (activated) (Xigris) for the treatment of severe sepsis in adults: a systematic review and economic evaluation. Health Technol. Assess. (2005) 9(11):1-126, iii-iv.
- ANGUS DC, LINDE-ZWIRBLE WT, CLERMONT G et al.: Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis. Crit. Care Med. (2003) 31:1-11.
- MANNS BJ, LEE H, DOIG CJ, JOHNSON D, DONALDSON C: An economic evaluation of activated protein C treatment for severe sepsis. N. Engl. J. Med. (2002) 347:993-1000.
- NEILSON AR, BURCHARDI H, CHINN C, CLOUTH J, SCHNEIDER H, ANGUS D: Cost-effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in Germany. J. Crit. Care (2003) 18:217-227.
- SACRISTAN JA, PRIETO L, HUETE T et al.: Cost-effectiveness of drotrecogin alfa [activated] in the treatment of severe sepsis in Spain. Gac. Sanit. (2004) 18:50-57.
- DAVIES A, RIDLEY S, HUTTON J, CHINN C, BARBER B, ANGUS DC: Cost effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in the United Kingdom. Anaesthesia (2005) 60:155-162.
- HJELMGREN J, PERSSON U, TENNVALL GR: Local treatment pattern versus trial-based data: a cost-effectiveness analysis of drotrecogin alfa (activated) in the treatment of severe sepsis in Sweden. Am. J. Ther. (2005) 12:425-430.
- RIOU FL, LAUNOIS R, LE LAY K et al.: Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis with multiple organ failure. Int. J. Technol. Assess. Healthcare (2006) 22:101-108.
- KUBLER A, MAYZNER-ZAWADZKA E, DUREK G et al.: Results of severe sepsis treatment programme using recombinant human activated protein C in Poland. Med. Sci. Monit. (2006) 12:CR107-CR112.
- KANJI S, PERREAULT MM, CHANT C, WILLIAMSON D, BURRY L: Evaluating the use of drotrecogin alfa (activated) in adult severe sepsis: a Canadian multicenter observational study. Intensive Care Med. (2007) 33:517-523.
- BERTOLINI G, ROSSI C, ANGHILERI A, LIVIGNI S, ADDIS A, POOLE D: Use of drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey. Intensive Care Med. (2007) 33:426-434.
- VINCENT JL, LATERRE PF, DECRUYENAERE J et al.: A registry of patients treated with drotrecogin alfa (activated) in Belgian intensive care units – an observational study. Acta Clin. Belg. (2007) (In Press).
- ABRAHAM E, REINHART K, OPAL S et al.: Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA (2003) 290:238-247.
- DE BACKER D, CRETEUR J, PREISER JC, DUBOIS MJ, VINCENT JL: Microvascular blood flow is altered in patients with sepsis. Am. J. Respir. Crit. Care Med. (2002) 166:98-104.
- SPRONK PE, INCE C, GARDIEN MJ, MATHURA KR, OUDEMANS-VAN STRAATEN HM, ZANDSTRA DF: Nitroglycerin in septic shock after intravascular volume resuscitation. Lancet (2002) 360:1395-1396.
- MOSNIER LO, GALE AJ, YEGNESWARAN S, GRIFFIN JH: Activated protein C variants with normal cytoprotective but reduced anticoagulant activity. Blood (2004) 104:1740-1744.
Websites
- http://pi.lilly.com/us/xigris.pdf Lilly prescribing information for Xigris (2007).
- http://www.fda.gov/ohrms/dockets/ac/01/briefing/3797b1_02_FDAbriefing.pdf FDA Xigris Briefing Document (2001).
- http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3797t1.htm FDA Anti-infective Drugs Advisery Committee October 21, 2001 Proceedings (2001).
- http://www.fda.gov/medwatch/safety/2005/xigris_DHCP.htm FDA MedWatch 2005 Safety Alert: Xigris (2005).
- http://www.emea.europa.eu/humandocs/PDFs/EPAR/xigris/Xigris-H-C-396-S-21.pdf EMEA European Public Assessment Report 4th Annual Reassessment Scientific Discussion (2007).
- http://www.emea.europa.eu/humandocs/PDFs/EPAR/xigris/Xigris-H-C-396-II-20.pdf EMEA EPAR XPRESS Study Report Scientific Discussion (2007).