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

Ely EW, Angus DC, Williams MD, Bates B, Qualy R, Bernard GR
Clin Infect Dis. 2003 37 (2): 187-95

PMID: 12856210 · DOI:10.1086/375775

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.

MeSH Terms (16)

Aged Aged, 80 and over Anti-Infective Agents Double-Blind Method Female Health Resources Humans Male Morbidity Multivariate Analysis Prospective Studies Protein C Recombinant Proteins Sepsis Survival Rate Treatment Outcome

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