Clinical trials in severe sepsis with drotrecogin alfa (activated).
Drotecogin alfa (activated; DrotAA) was approved in 2001 by the US Food and Drug Administration for the treatment of patients with severe sepsis who are at high risk for death. The European Agency for the Evaluation of Medical Products also recommended that DrotAA could be administered to patients with severe sepsis and multiple organ dysfunction when added to the best standard care. Following the initial publication of the PROWESS (Protein C Worldwide Evaluation in Severe Sepsis) findings, multiple subgroup analyses supported the need for additional studies to explore the various hypotheses raised by this study. This review discusses all large clinical trials exploring the efficacy and safety of DrotAA and proposes recommendations for the use of DrotAA in severe sepsis.
Laterre
Pierre-François
PF
Department of Critical Care Medicine, St-Luc University Hospital, Université Catholique de Louvain, Avenue Hippocrate, 1200 Brussels, Belgium. laterre@rean.ucl.ac.be
D018806:APACHE; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D004333:Drug Administration Routes; D004334:Drug Administration Schedule; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D015337:Multicenter Studies as Topic; D011358:Product Surveillance, Postmarketing; D011486:Protein C / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D012107:Research Design; D018805:Sepsis / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
D000890:Anti-Infective Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated