• David T Bearden and Cory G Garvin.
• Department of Pharmacy Practice, College of Pharmacy, Oregon State University, Portland, OR 97239-3098, USA. beardend@ohsu.edu
• Ann Pharmacother. 2002 Sep 1; 36 (9): 1424-9.

ObjectiveTo review the efficacy and safety of drotrecogin alfa (recombinant human activated protein C) in the treatment of sepsis.Data SourcesLiterature was identified through a MEDLINE search (1966-January 2002), the product manufacturer, and the Food and Drug Administration.Study Selection/Data ExtractionAll relevant information identified from the data sources was evaluated.Data SynthesisDrotrecogin 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.ConclusionsDrotrecogin 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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