A systematic review including 2 studies with a total of 1821 subjects was abstracted in DARE. The combined overall 28-day mortality rate was 25.1% in patients treated with drotrecogin alfa (activated) and 31.0% in those treated with placebo (RR 0.81, 95% CI: 0.70 to 0.94). Based on data from all available clinical studies, 2.3% of patients on placebo experienced a serious bleeding event, compared with 5.3% of those who had received drotrecogin alfa (activated).
Comment: The quality of evidence is downgraded by indirectness (lack of reporting corticosteroid use which may affect mortality).