• Expert Opin Drug Saf · Nov 2004

    Review

    Safety of drotrecogin alfa (activated) in the treatment of patients with severe sepsis.

    • Christopher McCoy.
    • Beth Israel Deaconess Medical Center, One Deaconess Road/Palmer 504, Boston, MA 02215, USA. cmccoy@bidmc.harvard.edu
    • Expert Opin Drug Saf. 2004 Nov 1;3(6):625-37.

    AbstractWhile severe sepsis continues to plague hospitals worldwide, new treatment modalities, including activated recombinant protein C (drotrecogin alfa, Xigris, Lilly), have become a standard treatment alternative in many institutional algorithms. Drotrecogin alfa was shown to have a beneficial effect on mortality versus placebo in the PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) trial (p = 0.005), but its use is not completely without risk. An increased risk of bleeding, including severe bleeding episodes, exists ranging 3.5 - 5.2% in the drotrecogin alfa treatment group versus 2.0 - 5.0% in the placebo group. Patients at risk include those on concomitant heparin therapy (> 15,000 units/day), those with platelet counts

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