COMMENTARY: Drotrecogin-α (activated) did not reduce death and increased bleeding in patients with severe sepsis and low risk for death

Carlet, Jean
March 2006
ACP Journal Club;Mar/Apr2006, Vol. 144 Issue 2, p43
Academic Journal
This article reports that the approval of Drotrecogin-α (activated) by the U.S. Food and Drug Administration required a randomized trial to establish the safety and effectiveness of the drug in patients with severe sepsis and low risk for death. This was considered important because the drug was approved only in patients at high risk for death. The sample size calculation for the study indicated the need to enroll 11 444 patients to show a difference of 4% in mortality between groups. The study was stopped because of futility after 2640 patients were randomized.


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