• Clin. Infect. Dis. · Jul 2003

    Randomized Controlled Trial Clinical Trial

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

    • E Wesley Ely, Derek C Angus, Mark D Williams, Becky Bates, Rebecca Qualy, and Gordon R Bernard.
    • Division of Allergy, Center for Health Services Research, Vanderbilt University School of Medicine, Nashville, Tennessee 37232-8300 , USA. wes.ely@vanderbilt.edu
    • Clin. Infect. Dis. 2003 Jul 15;37(2):187-95.

    AbstractThe 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.

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