Drotrecogin alfa (activated) treatment of older patients with severe sepsis

Clin Infect Dis. 2003 Jul 15;37(2):187-95. doi: 10.1086/375775. Epub 2003 Jul 8.

Abstract

The incidence of severe sepsis increases dramatically with advanced age, with a mortality rate that approaches 50%. The main purpose of this investigation was to determine both short- and long-term survival outcomes among 386 patients aged >or=75 years who were enrolled in the Protein C Worldwide Evaluation of Severe Sepsis (PROWESS) trial. Subjects who were treated with drotrecogin alfa (activated; DAA) had absolute risk reductions in 28-day and in-hospital mortality of 15.5% and 15.6%, respectively (P=.002 for both), compared with placebo recipients. The relative risk (RR) for 28-day mortality was 0.68 (95% confidence interval [CI], 0.54-0.87), and the in-hospital RR was 0.70 (95% CI, 0.56-0.88). Resource use and patient disposition for DAA-treated patients compared favorably with those for placebo recipients. In addition, long-term follow-up data were available for 375 subjects (97.2%), and survival rates for DAA recipients were significantly higher over a 2-year period (P=.02). The incidences of serious adverse bleeding during the 28-day study period in the DAA and placebo groups were 3.9% and 2.2%, respectively (P=.34). There was no interaction between age and bleeding rates (P=.97). In conclusion, older patients with severe sepsis have higher short- and long-term survival rates when treated with DAA than when treated with placebo but an increased risk of serious bleeding that is not aged related.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Health Resources
  • Humans
  • Male
  • Morbidity
  • Multivariate Analysis
  • Prospective Studies
  • Protein C / adverse effects
  • Protein C / therapeutic use*
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use*
  • Sepsis / drug therapy*
  • Sepsis / mortality
  • Survival Rate
  • Treatment Outcome

Substances

  • Anti-Infective Agents
  • Protein C
  • Recombinant Proteins
  • drotrecogin alfa activated