title: Risk-benefit analysis for drotrecogin alfa (activated).
abstract: An analysis of risks and benefits is an important component of patient care. Drotrecogin alfa (activated), the first approved cogin (a class of recombinant human coagulation inhibitors), provides a clear example of a treatment that requires a careful risk-benefit analysis. Treatment with this novel compound has been shown to reduce significantly the risk of death in patients with sepsis and acute organ dysfunction (severe sepsis). However, the drug is a natural antithrombotic that can increase the risk of bleeding in recipients. We will discuss bleeding and other potential risks associated with drotrecogin alfa (activated) treatment, as well as the survival benefits seen with the use of this therapy in patients with severe sepsis.
authors.affiliation: Division of Pulmonary and Critical Care Medicine, University of Miami School of Medicine, Critical Care Medicine (III), 11300 Northeast Second Avenue, Miami Shore, FL 33125, USA. rschein@med.miami.edu
authors.forename: Roland M H
authors.initials: RM
authors.lastname: Schein
authors.forename: Gary T
authors.initials: GT
authors.lastname: Kinasewitz
mesh_terms: D018806:APACHE; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D015981:Epidemiologic Factors; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006403:Hematologic Tests; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D018579:Patient Selection; D011486:Protein C / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D018570:Risk Assessment; D012307:Risk Factors; D018746:Systemic Inflammatory Response Syndrome / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality
chemical_list: D000890:Anti-Infective Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005343:Fibrinolytic Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated