Background
The purpose of this study was to characterize the usage patterns and clinical outcomes of DAA in Ontario and Quebec over a 1-year
period.
Methods
All hospitals with DAA on formulary in Ontario and Quebec were invited to participate. Consecutive patients who received DAA
from 1 March 2003 to 29 February 2004 were identified retrospectively. Demographic, treatment, and outcome variables were
collected via chart review. Descriptive statistics on relevant variables were performed, along with logistic regression to
determine relevant risk factors for survival and bleeding.
Results
Thirty-seven sites participated with a total of 261 courses of DAA administered. The overall mortality rate was 45%; age (> 65
years), multiple organ system failure (> 3), and nosocomial source of sepsis were predictors of mortality, whereas early DAA
administration (< 12 h) was associated with lower mortality. Serious bleeding events occurred in 10% of the patients. Only
1 case (0.4%) of fatal intracranial bleed was observed. Multiple organ system failure (≥ 4)and relative contraindications
to DAA were predictors of bleeding events.
Interpretation
Mortality and bleeding complications associated with the use of DAA were higher than that reported in randomized trials but
similar to other usage database. This may be due to the higher severity of illness seen in this cohort of patients. Modifiable
risks associated with mortality and bleeding, such as time to treatment, and knowledge of relative contraindications should
be targets of further research and future educational efforts in order to optimize the risk-to-benefit ratio of DAA.
Keywords Drotrecogin alfa (activated) - Sepsis - Severe sepsis - Post-marketing surveillance - Drug utilization evaluation
This article is discussed in the editorial available at: http://dx.doi.org/10.1007/s00134-007-0556-8