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Drug for Severe Adult Sepsis
Bernard A. Schwetz, DVM,PhD
JAMA. 2002;287:33.
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The FDA has approved drotrecogin alfa (activated) (Xigris, Eli Lilly, Indianapolis), a recombinant form of human activated protein C, for the reduction of mortality in adults with severe sepsis (associated with acute organ dysfunction).
The effectiveness of the drug was shown in a multicenter, randomized, double-blind, placebo-controlled trial of 1690 adult patients with severe sepsis. Entry criteria included a systemic inflammatory response presumed due to infection and at least one of the following: cardiovascular, respiratory, or renal dysfunction; thrombocytopenia; or metabolic acidosis.
Patients received a 96-hour infusion of Xigris at 24 µg/kg per hour (the recommended dosage) or placebo within 48 hours after onset of the first sepsis-induced organ dysfunction. The primary efficacy end point was all-cause mortality assessed 28 days after the start of Xigris administration. The study was terminated after a planned interim analysis because of significantly lower mortality in patients who received Xigris . . . [Full Text of this Article]
Acting Principal Deputy Commissioner
Food and Drug Administration
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
Use of drotrecogin alfa (activated) for severe sepsis in New Jersey acute care hospitals.
Dombrovskiy et al.
Am J Health Syst Pharm 2006;63:1151-1156.
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