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: | William L. Macias, Mary Ann Turlo, Christopher J. Doig, Christian Putensen, Antonio Artigas, JF Dhainaut, Richard Beale, Kar Wong, Jonathan Janes, Roberto Fumagalli, David P. Sundin, Jean Louis Vincent, Gordon R. Bernard, Theressa J. Wright |
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| Přispěvatelé: | Vincent, J, Bernard, G, Beale, R, Doig, C, Putensen, C, Dhainaut, J, Artigas, A, Fumagalli, R, Macias, W, Wright, T, Wong, K, Sundin, D, Turlo, M, Janes, J |
| Rok vydání: | 2005 |
| Předmět: |
Anti-Infective Agent
Adult Male medicine.medical_specialty Resuscitation Sepsi medicine.drug_class macromolecular substances Critical Care and Intensive Care Medicine Drug Administration Schedule Follow-Up Studie Sepsis Anti-Infective Agents stomatognathic system Intensive care medicine Humans MED/41 - ANESTESIOLOGIA Intensive care medicine Survival rate Aged Intracranial Hemorrhage business.industry Drotrecogin alfa Anticoagulant virus diseases Recombinant Protein Middle Aged medicine.disease Recombinant Proteins digestive system diseases Survival Rate Clinical trial Treatment Outcome Female business Intracranial Hemorrhages Protein C Follow-Up Studies Human medicine.drug |
| Zdroj: | Critical Care Medicine. 33:2266-2277 |
| ISSN: | 0090-3493 |
| DOI: | 10.1097/01.ccm.0000181729.46010.83 |
| Popis: | 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. Enrolment 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 drofrecogin 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 (22.3% 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 |
| Databáze: | OpenAIRE |
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