Related Experiment Videos
Recombinant human activated protein C for use in severe sepsis
David T Bearden1, Cory G Garvin
1Department of Pharmacy Practice, College of Pharmacy, Oregon State University, Portland, OR 97239-3098, USA. beardend@ohsu.edu
Objective:
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.