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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, Jean-Louis ; Bernard, Gordon R ; Beale, Richard ; Doig, Christopher ; Putensen, Christian ; Dhainaut, Jean-Francois ; Artigas, Antonio ; Fumagalli, Roberto ; Macias, William ; Wright, Theressa ; Wong, Kar ; Sundin, David P ; Turlo, Mary Ann ; Janes, Jonathan

Critical care medicine, 2005-10, Vol.33 (10), p.2266-2277 [Periódico revisado por pares]

Hagerstown, MD: by the Society of Critical Care Medicine and Lippincott Williams & Wilkins

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Título:
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
Autor: Vincent, Jean-Louis ; Bernard, Gordon R ; Beale, Richard ; Doig, Christopher ; Putensen, Christian ; Dhainaut, Jean-Francois ; Artigas, Antonio ; Fumagalli, Roberto ; Macias, William ; Wright, Theressa ; Wong, Kar ; Sundin, David P ; Turlo, Mary Ann ; Janes, Jonathan
Assuntos: Adult ; Aged ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Anti-Infective Agents - adverse effects ; Anti-Infective Agents - therapeutic use ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Drug Administration Schedule ; Emergency and intensive care: infection, septic shock ; Female ; Follow-Up Studies ; Humans ; Intensive care medicine ; Intracranial Hemorrhages - chemically induced ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Protein C - adverse effects ; Protein C - therapeutic use ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Sepsis - drug therapy ; Sepsis - mortality ; Survival Rate ; Treatment Outcome
É parte de: Critical care medicine, 2005-10, Vol.33 (10), p.2266-2277
Descrição: OBJECTIVE:To provide further evidence for the efficacy and safety of drotrecogin alfa (activated) treatment in severe sepsis. DESIGN:Single-arm, open-label, trial of drotrecogin alfa (activated) treatment in severe sepsis patients. Enrollment began in March 2001 and day-28 follow-up completed in January 2003. SETTING:ENHANCE took place in 25 countries at 361 sites. PATIENTS:Patients with known or suspected infection, three or four systemic inflammatory response syndrome criteria, and one or more sepsis-induced organ dysfunctions. Of 2,434 adults entered, 2,378 received drotrecogin alfa (activated), and of these, 2,375 completed the protocol. INTERVENTIONS:Drotrecogin alfa (activated) was infused at a dose of 24 μg/kg/hr for 96 hrs. MEASUREMENTS AND MAIN RESULTS:The 28-day all-cause mortality approximated that observed in PROWESS (25.3% vs. 24.7%). Although patients in ENHANCE had increased serious bleeding rates compared with patients in the drotrecogin alfa (activated) arm of PROWESS (during infusion, 3.6% vs. 2.4%; postinfusion, 3.2% vs. 1.2%; 28-day, 6.5% vs. 3.5%), increased postinfusion bleeding suggested a higher background bleeding rate. Intracranial hemorrhage was more common in ENHANCE than PROWESS (during infusion, 0.6% vs. 0.2%; 28-day, 1.5% vs. 0.2%). The incidence of fatal intracranial hemorrhage was the same during infusion (0.2%) and higher at 28 days (0.5% vs. 0.2%). ENHANCE patients treated within 0–24 hrs from their first sepsis-induced organ dysfunction had lower observed mortality rate than those treated after 24 hrs (22.9% vs. 27.4%, p = .01). CONCLUSIONS:ENHANCE provides supportive evidence for the favorable benefit/risk ratio observed in PROWESS and suggests that more effective use of drotrecogin alfa (activated) might be obtained by initiating therapy earlier.
Editor: Hagerstown, MD: by the Society of Critical Care Medicine and Lippincott Williams & Wilkins
Idioma: Inglês

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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, Jean-Louis ; Bernard, Gordon R ; Beale, Richard ; Doig, Christopher ; Putensen, Christian ; Dhainaut, Jean-Francois ; Artigas, Antonio ; Fumagalli, Roberto ; Macias, William ; Wright, Theressa ; Wong, Kar ; Sundin, David P ; Turlo, Mary Ann ; Janes, Jonathan

Hagerstown, MD: by the Society of Critical Care Medicine and Lippincott Williams & Wilkins

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