, Volume 33, Issue 3, pp 396-399
Date: 15 Feb 2007

Increasing evidence that the risks of rhAPC may outweigh its benefits

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Sir: The surveys by Kanji et al. and Bertolini et al. in this issue of “Intensive Care Medicine” are important in providing further insights into the increased bleeding risks associated with recombinant human activated protein C (rhAPC) in clinical practice [1, 2]. Following approval of rhAPC in 2001, early surveys and post-marketing studies suggested that the risk of bleeding during clinical use might be greater than was noted in the original phase-3 trial [Recombinant Human Activated protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial; 3, 4, 5, 6]. Even more concerning, two additional randomized controlled sepsis trials conducted post-approval have failed to show any significant benefit with rhAPC [7, 8]. In light of increasing experience with rhAPC, the critical care community should reconsider whether the bleeding risks associated with this agent outweigh its purported benefit.

Increased bleeding with rhAPC has been a consistent finding in all sepsis trials conducted to

This editorial refers to the articles available at: http://dx.doi.org/10.1007/s00134-007-0554-x and http://dx.doi.org/10.1007/s00134-007-0555-9