To review the efficacy and safety of drotrecogin alfa (recombinant human activated protein C) in the treatment of sepsis.
DATA SOURCES:
Literature was identified through a MEDLINE search (1966–January 2002), the product manufacturer, and the Food and Drug Administration.
STUDY SELECTION/DATA EXTRACTION:
All relevant information identified from the data sources was evaluated.
DATA SYNTHESIS:
Drotrecogin alfa reduces coagulation and inflammation in septic patients. A large placebo-controlled clinical trial (n = 1690) of drotrecogin alfa in severely septic patients demonstrated a reduction in mortality (24.7% vs. 30.8%; p = 0.005), with increased bleeding risks (24.9% vs. 17.7%; p <0.001). Patients with more severe sepsis appeared to gain the most benefit. The complete clinical and economic impact of this agent requires further analysis.
CONCLUSIONS:
Drotrecogin alfa offers a significant advance in the treatment of severe sepsis. Judicious use in appropriate patients is necessary to control cost and maximize clinical benefits.
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