Published in:
01-02-2004 | Poster presentation
The efficacy of Drotrecogin alfa (activated) during a global, single-arm, open-label trial in adult patients with severe sepsis (ENHANCE): comparisons with PROWESS
Authors:
J Vincent, G Bernard, J Dhainaut, M Levy, A Wheeler, W Macias
Published in:
Critical Care
|
Special Issue 1/2004
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Excerpt
Treatment with Drotrecogin alfa (activated) (DrotAA) in a phase 3 clinical trial (PROWESS, n = 1690) was associated with a significant survival advantage and favorable benefit–risk profile compared with placebo in adult patients with severe sepsis. A global, single-arm, open-label trial of DrotAA in adult patients with severe sepsis was subsequently conducted at 361 sites in 25 countries (ENHANCE, n = 2378). Here, the efficacies of DrotAA in ENHANCE and PROWESS were compared, with all-cause mortality at 28 days as the primary study endpoint. …