Drotrecogin Alfa (Activated): The First Fda-Approved Treatment for Severe Sepsis (Pharmacology Notes) (Drug Overview)
Drotrecogin alfa (activated) (Xigris, Eli Lilly and Company, Indianapolis, Ind) is a recombinant form of human activated protein C. It was approved by the Food and Drug Administration in the last quarter of 2001 for the reduction of mortality due to severe sepsis in adult patients who are at high risk of death (1). This is a unique indication. While many investigational drugs have been proposed as treatments for sepsis in the past, and several have even made it to clinical trials (2), only drotrecogin alfa (activated) has shown a survival benefit. The definition of sepsis given by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference has 2 parts: infection and 2 of the 4 systemic inflammatory response syndrome (SIRS) criteria (temperature [greater than or equal to]38[degrees]C or [less than or equal to]36[degrees]C, heart rate [greater than or equal to]90 beats/minute, respiratory rate [greater than or equal to]20 breaths/minute or PaC[O.sub.2] [less than or equal to]32 mm Hg, white blood cell count [greater than or equal to] 12,000/[micro]L or [less than or equal to]4000/[micro]L or 10% immature forms). The definition of severe sepsis includes the above plus organ dysfunction, hypoperfusion, or hypotension (3). This syndrome is a result of the body’s systemic inflammatory and procoagulant responses to infection and is associated with significant morbidity and mortality (4, 5).