Activated protein C for severe sepsis.
Severe sepsis is a systemic inflammatory response to infection involving organ dysfunction. Severe sepsis is a common cause of death and is associated with a 20% to 56% mortality rate. Drotrecogin alpha (activated) is a recombinant human activated protein C(rhAPC) approved in the U.S. for the reduction of mortality in adult patients with severe sepsis who have a high risk of death. Drotrecogin alpha (activated), when administered to adult patients with clinically defined severe sepsis, demonstrated a 6.1% absolute reduction (p=0.005) in 28-day all-cause mortality in one published, randomized, double-blind study of 1,690 patients (PROWESS). Drotrecogin alpha (activated) is used as an adjunct to standard therapy and is therefore and "add-on" cost. Close attention must be paid to proper patient selection for treatment with drotrecogin alpha (activated). Certain individuals, such as those at a greater risk of bleeding, could be harmed from therapy. The benefit or harm in individuals not meeting the trial selection criteria is uncertain.
Garces
Kirsten
K
D000328:Adult; D002986:Clinical Trials as Topic; D003365:Costs and Cost Analysis; D017277:Drug Approval; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D011486:Protein C / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D018805:Sepsis / Q000188:drug therapy* / Q000401:mortality; D014481:United States; D014486:United States Food and Drug Administration
D005343:Fibrinolytic Agents; D011486:Protein C