title: [Questionable efficacy and safety of activated drotrecogin alpha (activated protein C) in the treatment of severe sepsis].
abstract: Activated protein C (APC) has both anticoagulant and anti-inflammatory properties. In a clinical trial, recombinant APC reduced the mortality rate in patients with severe sepsis by 6.1%. However, the results were felt to be questionable. In sepsis patients with a low risk of death, no beneficial effect of APC was apparent. In addition, concern had been voiced about the increased risk of serious bleeding. A new study was therefore carried out in patients with severe sepsis and a lower risk of death. This trial was terminated prematurely because no benefit from APC could be observed. In a post-hoc analysis, increased mortality was found in patients who had undergone recent surgery. Additional information is required to establish definitively the efficacy and safety of recombinant APC in patients with severe sepsis and a high risk of death.
authors.affiliation: Meander Medisch Centrum, afd. Intensive Care en Interne Geneeskunde, Utrechtseweg 160, 3818 ES Amersfoort. akm.bartelink@meandermc.nl
authors.forename: A K M
authors.initials: AK
authors.lastname: Bartelink
mesh_terms: D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003257:Consumer Product Safety; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D011486:Protein C / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012307:Risk Factors; D018805:Sepsis / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated