Recombinant human activated protein C in sepsis: inconsistent trial results, an unclear mechanism of action, and safety concerns resulted in labeling restrictions and the need for phase IV trials.
Eichacker
Peter Q
PQ
Critical Care Medicine Department, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Natanson
Charles
C
D000818:Animals; D000890:Anti-Infective Agents / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D004195:Disease Models, Animal; D017277:Drug Approval; D004348:Drug Labeling; D006801:Humans; D011486:Protein C / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D051381:Rats; D011994:Recombinant Proteins / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D018805:Sepsis / Q000188:drug therapy*
D000890:Anti-Infective Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated