Abstract
Drotecogin alfa (activated; DrotAA) was approved in 2001 by the US Food and Drug Administration for the treatment of patients with severe sepsis who are at high risk for death. The European Agency for the Evaluation of Medical Products also recommended that DrotAA could be administered to patients with severe sepsis and multiple organ dysfunction when added to the best standard care. Following the initial publication of the PROWESS (Protein C Worldwide Evaluation in Severe Sepsis) findings, multiple subgroup analyses supported the need for additional studies to explore the various hypotheses raised by this study. This review discusses all large clinical trials exploring the efficacy and safety of DrotAA and proposes recommendations for the use of DrotAA in severe sepsis.
Highlights
Drotecogin alfa is a recombinant form of the natural anticoagulant activated protein C, and it was approved by the US Food and Drug Administration (FDA) in November 2001 for the treatment of adult patients with severe sepsis at high risk of death
Other studies were mandated by the FDA to explore the hypotheses generated by subgroup analyses from PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis), which suggested that patients at low risk for death might be harmed by DrotAA and that heparin prophylaxis could reduce the survival benefit conferred by DrotAA
In light of the various clinical trials evaluating the efficacy and safety of DrotAA in severe sepsis, we can conclude that DrotAA can reduce mortality in patients with severe sepsis at high risk for death
Summary
Drotecogin alfa (activated [DrotAA]; Xigris®; Eli Lilly and Company, Indianapolis, IN, USA) is a recombinant form of the natural anticoagulant activated protein C, and it was approved by the US Food and Drug Administration (FDA) in November 2001 for the treatment of adult patients with severe sepsis at high risk of death (for instance, as indicated by Acute Physiology and Chronic Health Evaluation [APACHE] II score). Not powered to evaluate this end-point, the 28-day, all-cause mortality in the 24 to 32 μg/kg per hour arm was reduced compared with placebo (34.1% versus 28.9%) Together with these recommendations, other studies were mandated by the FDA to explore the hypotheses generated by subgroup analyses from PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis), which suggested that patients at low risk for death might be harmed by DrotAA and that heparin prophylaxis could reduce the survival benefit conferred by DrotAA.
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