Heavy Sepsis Effectiveness and Safety of Recombinant Human Activated Protein C

Abstract

Drotrecogin alfa (activated) or recombinant human activated protein C (rhAPC) has been registered for use as adjuvant treatment in severe sepsis since 2001 under the trade name Xigris essentially based on the results from one large clinical trial (the PROWESS-Worldwide Evaluation in Severe Sepsis trial). Drotrecogin alfa (activated) produces a robust reduction in the mortality rate of patients with severe sepsis that is evident across nearly every subgroup examined in the phase III clinical trial and has an acceptable safety profile with bleeding during infusion as the only significant risk associated with therapy. In patients with similar numbers of injured organs, mortality rates may be higher with rhAPC during clinical use compared with the phase ill trial There may also be an increased risk of hemorrhage and other adverse events that necessitate early discontinuation of treatment A confirmatory clinical trial is required before rhAPC can be used with confidence. The side-effects and the cost of rhAPC are well documented but its efficacy is not.