Benefit/risk profile of drotrecogin alfa (activated) in surgical patients with severe sepsis

Philip S Barie; Mark D Williams; Jill Shwed McCollam; Becky M Bates; Rebecca L Qualy; Stephen F Lowry; Donald E Fry; PROWESS Surgical Evaluation Committee

doi:10.1016/j.amjsurg.2004.06.008

Benefit/risk profile of drotrecogin alfa (activated) in surgical patients with severe sepsis

Am J Surg. 2004 Sep;188(3):212-20. doi: 10.1016/j.amjsurg.2004.06.008.

Authors

Philip S Barie¹, Mark D Williams, Jill Shwed McCollam, Becky M Bates, Rebecca L Qualy, Stephen F Lowry, Donald E Fry; PROWESS Surgical Evaluation Committee

Affiliation

¹ Division of Critical Care and Trauma, Weill Medical College of Cornell University, Payson 713A, 525 E. 68th St., New York, NY 10021, USA. pbarie@med.cornell.edu

PMID: 15450822
DOI: 10.1016/j.amjsurg.2004.06.008

Abstract

Background: The Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial examined the safety and efficacy of drotrecogin alfa (activated) (Xigris) in adult patients with severe sepsis. A clinical evaluation committee examined clinical data for each patient enrolled in PROWESS. However, there were no surgeons on the committee, and thus questions remained regarding the safety and efficacy of drotrecogin alfa (activated) in surgical patients.

Methods: Masked to treatment, a Surgical Evaluation Committee adjudicated the presence and type of operation, timing of surgery, infection, and adequacy of source control of surgical patients included in PROWESS.

Results: Twenty-eight percent of PROWESS cases were confirmed as surgical. The absolute risk reduction for mortality in all surgical patients was 3.2% and 9.1% for patients undergoing intraabdominal procedures. Serious bleeding during the infusion and 28-day period was similar between surgical and nonsurgical patients.

Conclusions: Consistent with the overall PROWESS results, drotrecogin alfa (activated) has a favorable benefit/risk profile in surgical patients.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Anti-Infective Agents / adverse effects
Anti-Infective Agents / therapeutic use*
Cohort Studies
Female
Hemorrhage / chemically induced
Humans
Male
Middle Aged
Protein C / adverse effects
Protein C / therapeutic use*
Recombinant Proteins / adverse effects
Recombinant Proteins / therapeutic use*
Retrospective Studies
Risk Assessment
Surgical Procedures, Operative / methods
Systemic Inflammatory Response Syndrome / drug therapy*
Systemic Inflammatory Response Syndrome / surgery
Treatment Outcome

Substances

Anti-Infective Agents
Protein C
Recombinant Proteins
drotrecogin alfa activated