Effects of drotrecogin alfa (activated) in human endotoxemia.

Andre C. Kalil, Susette M. Coyle, John Y. Um, Steven P. LaRosa, Mary Ann Turlo, Steve E. Calvano, David P. Sundin, David R. Nelson, Stephen F. Lowry

Research output: Contribution to journalArticle

67 Scopus citations

Abstract

In a phase III clinical trial, drotrecogin alfa (activated) was shown to improve survival and promote faster improvement of cardiovascular and respiratory dysfunction in patients with severe sepsis. To further examine mechanisms involved in the action of this drug, a healthy human endotoxin model was used. Healthy volunteers (eight per group) received drotrecogin alfa (activated) or placebo intravenously for 8 h in a randomized, double-blind, controlled manner. After 2 h of study drug infusion, endotoxin (2 ng/kg) was infused and measurement of physiologic responses and biomarkers continued for 24 h. Consistent with results from severe sepsis clinical trials, drotrecogin alfa (activated) improved mean arterial pressure during the period of infusion after endotoxin exposure. In contrast to severe sepsis clinical trials using drotrecogin alfa (activated) but similar to another human endotoxin study, no significant antithrombotic, profibrinolytic, or anti-inflammatory effects were observed. These results suggest a novel role for drotrecogin alfa (activated) in the human endotoxin model.

Original languageEnglish (US)
Pages (from-to)222-229
Number of pages8
JournalShock (Augusta, Ga.)
Volume21
Issue number3
DOIs
StatePublished - Mar 2004

ASJC Scopus subject areas

  • Emergency Medicine
  • Critical Care and Intensive Care Medicine

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    Kalil, A. C., Coyle, S. M., Um, J. Y., LaRosa, S. P., Turlo, M. A., Calvano, S. E., Sundin, D. P., Nelson, D. R., & Lowry, S. F. (2004). Effects of drotrecogin alfa (activated) in human endotoxemia. Shock (Augusta, Ga.), 21(3), 222-229. https://doi.org/10.1097/01.shk.0000116778.27924.79